Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-03-03 @ 6:29 AM
Study NCT ID:
NCT02032433
Status:
COMPLETED
Last Update Posted:
2020-08-13
First Post:
2013-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000624616', 'term': 'vivitrol'}, {'id': 'D000069479', 'term': 'Buprenorphine, Naloxone Drug Combination'}], 'ancestors': [{'id': 'D002047', 'term': 'Buprenorphine'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'john.rotrosen@nyumc.org', 'phone': '646-754-4763', 'title': 'John Rotrosen', 'organization': 'NYU School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Weeks 0-36', 'description': 'Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)', 'otherNumAtRisk': 283, 'deathsNumAtRisk': 283, 'otherNumAffected': 118, 'seriousNumAtRisk': 283, 'deathsNumAffected': 3, 'seriousNumAffected': 41}, {'id': 'EG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)', 'otherNumAtRisk': 287, 'deathsNumAtRisk': 287, 'otherNumAffected': 135, 'seriousNumAtRisk': 287, 'deathsNumAffected': 4, 'seriousNumAffected': 31}], 'otherEvents': [{'term': 'Gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 58}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Psychiatric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 22}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Injury poisoning and procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 22}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nervous system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'General Disorders and Administration Site Conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Musculoskeletal and connective tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Respiratory, thoracic and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Skin and subcutaneous tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Metabolism and nutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Renal and urinary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Reproductive system and breast disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Surgical and medical procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 3}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hepatbiliary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Ear and labyrinth disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Immune system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cardiac disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Social circumstances', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Blood and lymphatic system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Product issues', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'seriousEvents': [{'term': 'Psychiatric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 287, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Injury, poisoning and procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Respiratory, thoracic, and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Nervous system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Musculoskeletal and connective tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Metabolism and nutrition disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Hepatobiliary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Reproductive system and breast disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Relapse (Intent to Treat Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '23.4'}, {'value': '14.4', 'groupId': 'OG001', 'lowerLimit': '5.1', 'upperLimit': '23.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 3-24', 'description': 'Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat.'}, {'type': 'PRIMARY', 'title': 'Time to Relapse (Per Protocol Population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '20.4', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '23.4'}, {'value': '15.2', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '23.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 3-24', 'description': 'Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population (those successfully inducted onto medication)'}, {'type': 'SECONDARY', 'title': 'Number Successfully Inducted Onto Assigned Study Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '204', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-24', 'description': 'Binary Y/N assessment of whether the participant was or was not able to initiate their assigned study medication.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}, {'type': 'SECONDARY', 'title': 'Adverse Events Related to Study Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '115', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0-36', 'description': 'Adverse events reported by participants and assessed by clinical staff for relatedness to study medication. These determinations were reviewed by the study medical monitor.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'These are treatment emergent adverse events. Treatment emergence is defined as any adverse events that occurred after the study day of induction for those participants inducted onto study medication.'}, {'type': 'SECONDARY', 'title': 'Opioid Abstinence Over Time While on Study Medication (Subjective)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '144'}, {'value': '87', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '144'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 0-24', 'description': 'Self report of opioid use by participants using the TLFB. At each visit, the TLFB was completed for dates going back to the last participant encounter.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol'}, {'type': 'SECONDARY', 'title': 'Alcohol Use Over Time, Drinks Per Day, Past 30 Days, W0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '.8', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '3.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'Alcohol use over time, drinks per day, past 30 days, at week 0', 'unitOfMeasure': 'drinks per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cigarette Smoking, W0, 10 or Less', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 0', 'description': 'Participants average cigarettes/day, in past 4 weeks, at week 0, equals 10 or less.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Opioid Craving Over Time W0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '68.7', 'spread': '30.55', 'groupId': 'OG000'}, {'value': '68.8', 'spread': '30.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'Opioid craving over time via VAS at week 0', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'spread': '6.45', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '6.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'The Subacute Withdrawal Symptoms Subscale consists of 6 symptoms. Classification of symptoms can be scored as: 0 - absent, 1 - doubtful or trivial, 2 - present. The total range of scores is 0 - 12, and the higher the total score the more severe the depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '.1', 'spread': '.2', 'groupId': 'OG000'}, {'value': '.1', 'spread': '.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'The Alcohol Subscale within ASI is one question that asks how bothered one has been by alcohol problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'spread': '8.85', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '10.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'The Sexual Behavior Subscale consists of 5 questions. Each question is scored from 0-5, for a total score range of 0-25. Higher scores indicate a greater degree of risk-taking behavior.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score on Trail Making Test Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '26.8', 'spread': '11.09', 'groupId': 'OG000'}, {'value': '25.8', 'spread': '10.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'Trail Making Test Part A consists of 25 circles distributed over a sheet of paper. The circles are number 1-25, and the patient is asked to draw lines to connect the numbers in ascending order. The patient is instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Higher scores reveal greater impairment.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Opioid Abstinence Over Time While on Study Medication (Objective)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '21'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Weeks 0-24', 'description': 'A urine sample was obtained and tested for opioids at each in person visit; screening, prior to induction onto study medication, weekly through week 24 and at each of the follow up visits.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol'}, {'type': 'SECONDARY', 'title': 'Cigarette Smoking, W0 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 0', 'description': 'Participants average cigarettes/day, in past 4 weeks, at week 0, equals none', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cigarette Smoking, W0 11-20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 0', 'description': 'Participants average cigarettes/day, in past 4 weeks, at week 0, equals 11-20.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cigarette Smoking, W0 21-30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 0', 'description': 'Participants average cigarettes/day, in past 4 weeks, at week 0, equals 21-30', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cigarette Smoking, W0 31 or More', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 0', 'description': 'Participants average cigarettes/day, in past 4 weeks, at week 0, equals 31 or more', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cigarette Smoking, W24 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'Participants average cigarettes/day, in past 4 weeks, at week 24, equals none', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cigarette Smoking', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'Participants average cigarettes/day, in past 4 weeks, at week 24, equals 10 or less.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cigarette Smoking, W24 11-20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'Participants average cigarettes/day, in past 4 weeks, at week 24, equals 11-20.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cigarette Smoking, W24 21-30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'Participants average cigarettes/day, in past 4 weeks, at week 24, equals 21-30', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cigarette Smoking, W24 31 or More', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'Participants average cigarettes/day, in past 4 weeks, at week 24, equals 31 or more', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score on Opioid Craving Scale (OCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'spread': '21.54', 'groupId': 'OG000'}, {'value': '9.4', 'spread': '17.67', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'OCS is a brief 3-item measure used to measure opioid craving. The scale consists of 3 items rated on a visual analogue scale (VAS) from 1-10. The total range of score is 0-30, and a higher score indicates a stronger craver / desire to use opiates.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '6.53', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '5.48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'The Subacute Withdrawal Symptoms Subscale consists of 6 symptoms. Classification of symptoms can be scored as: 0 - absent, 1 - doubtful or trivial, 2 - present. The total range of scores is 0 - 12, and the higher the total score the more severe the depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score on Subjective Opiate Withdrawal Scale (SOWS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '15.6', 'spread': '13.38', 'groupId': 'OG000'}, {'value': '15.6', 'spread': '13.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). The total range of scores is 0-64; the higher the score, the more intense the withdrawal.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score on Subjective Opiate Withdrawal Scale (SOWS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '7.53', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '7.49', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). The total range of scores is 0-64; the higher the score, the more intense the withdrawal.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '7.3', 'spread': '9.37', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '10.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'The Sexual Behavior Subscale consists of 5 questions. Each question is scored from 0-5, for a total score range of 0-25. Higher scores indicate a greater degree of risk-taking behavior.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '7.34', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '10.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'The Sexual Behavior Subscale consists of 3 questions. Each question is scored from 0-5, for a total score range of 0-15. Higher scores indicate a greater degree of risk-taking behavior.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '10.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'The Sexual Behavior Subscale consists of 3 questions. Each question is scored from 0-5, for a total score range of 0-15. Higher scores indicate a greater degree of risk-taking behavior.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score on Trail Making Test Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '21.6', 'spread': '9.81', 'groupId': 'OG000'}, {'value': '20.3', 'spread': '7.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'Trail Making Test Part A consists of 25 circles distributed over a sheet of paper. The circles are number 1-25, and the patient is asked to draw lines to connect the numbers in ascending order. The patient is instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Higher scores reveal greater impairment.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score on Trail Making Test Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '79.1', 'spread': '40.19', 'groupId': 'OG000'}, {'value': '78.3', 'spread': '40.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'Part B consists of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1-13) and letters (A-L); the patient draws lines to connect the circles in an ascending pattern, by alternating between the numbers and letters. Results are reported as the number of seconds required to complete the task.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score on Trail Making Test Part B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '61.2', 'spread': '39.32', 'groupId': 'OG000'}, {'value': '58.1', 'spread': '33.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'Part B consists of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1-13) and letters (A-L); the patient draws lines to connect the circles in an ascending pattern, by alternating between the numbers and letters. Results are reported as the number of seconds required to complete the task.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score on Word Card of Stoop Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '95.8', 'spread': '16.6', 'groupId': 'OG000'}, {'value': '96.4', 'spread': '16.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'The "word card" of the Stoop Test has the names of colors printed in black and white (100 items to be named). The patient\'s basic score is the total time he/she takes to utter the 100 words on the card.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score on Word Card of Stoop Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '103.2', 'spread': '18.02', 'groupId': 'OG000'}, {'value': '102.9', 'spread': '19.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'The "word card" of the Stoop Test has the names of colors printed in black and white (100 items to be named). The patient\'s basic score is the total time he/she takes to utter the 100 words on the card.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score on Color Card of Stoop Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '69.3', 'spread': '13.63', 'groupId': 'OG000'}, {'value': '70.5', 'spread': '12.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'The "color card" contains 100 patches of between 3-5 different colors. The patient\'s task is to utter the names of the colored patches as rapidly as possible, scanning the rows from left to right. The score is the total time (in seconds) it takes to utter the 100 colors.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score on Color Card of Stoop Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '75.3', 'spread': '15.31', 'groupId': 'OG000'}, {'value': '76.1', 'spread': '14.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'The "color card" contains 100 patches of between 3-5 different colors. The patient\'s task is to utter the names of the colored patches as rapidly as possible, scanning the rows from left to right. The score is the total time (in seconds) it takes to utter the 100 colors.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score on Color Word Card of Stoop Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '41.1', 'spread': '10.33', 'groupId': 'OG000'}, {'value': '42.2', 'spread': '9.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'The "color-word card" contains the printed names of colors, but printed in an ink of a conflicting color (e.g. the word RED might be printed in green, yellow, or blue). The patient is required to name the colors of the inks while ignoring the conflicting printed color names. The basic score is the total time (in seconds) to utter the 100 colors.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score on Color Word Card of Stoop Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '47.6', 'spread': '12.07', 'groupId': 'OG000'}, {'value': '48.8', 'spread': '12.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'The "color-word card" contains the printed names of colors, but printed in an ink of a conflicting color (e.g. the word RED might be printed in green, yellow, or blue). The patient is required to name the colors of the inks while ignoring the conflicting printed color names. The basic score is the total time (in seconds) to utter the 100 colors.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '.1', 'spread': '.11', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'The Alcohol Subscale within ASI is one question that asks how bothered one has been by alcohol problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '.3', 'spread': '0.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'The Drug Use Subscale within ASI is one question that asks how bothered one has been by drug use problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '.1', 'spread': '.13', 'groupId': 'OG000'}, {'value': '.1', 'spread': '.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'The Drug Use Subscale within ASI is one question that asks how bothered one has been by drug use problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score of Social Relationship Subscale Within Addiction Severity Index (ASI) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '.3', 'spread': '.25', 'groupId': 'OG000'}, {'value': '.3', 'spread': '.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'The Social Relationship Subscale within ASI contains 2 questions that ask how bothered one has been by family or social problems. The total range of the subscale is 0-8. The higher the score, the bigger the problem.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score of Family / Social Relationship Subscale Within Addiction Severity Index (ASI) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '.1', 'spread': '.18', 'groupId': 'OG000'}, {'value': '.1', 'spread': '.19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'The Family / Social Relationship Subscale within ASI contains 2 questions that ask how bothered one has been by family or social problems. The total range of the subscale is 0-8. The higher the score, the bigger the problem.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score of Legal Status Subscale Within Addiction Severity Index (ASI) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '.2', 'spread': '.21', 'groupId': 'OG000'}, {'value': '.2', 'spread': '.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'The Legal Status Subscale within ASI is one question that asks how bothered one has been by legal problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score of Legal Status Subscale Within Addiction Severity Index (ASI) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '.1', 'spread': '.17', 'groupId': 'OG000'}, {'value': '.1', 'spread': '.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'The Legal Status Subscale within ASI is one question that asks how bothered one has been by legal problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score of Medical Status Subscale Within Addiction Severity Index (ASI) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '.2', 'spread': '.25', 'groupId': 'OG000'}, {'value': '.2', 'spread': '.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'The Medical Status Subscale within ASI is one question that asks how bothered one has been by medical problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score of Medical Status Subscale Within Addiction Severity Index (ASI) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '.1', 'spread': '.24', 'groupId': 'OG000'}, {'value': '.2', 'spread': '.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'The Medical Status Subscale within ASI is one question that asks how bothered one has been by medical problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score of Psychiatric Status Subscale Within Addiction Severity Index (ASI) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '.3', 'spread': '.22', 'groupId': 'OG000'}, {'value': '.3', 'spread': '.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'The Psychiatric Status Subscale within ASI is one question that asks how bothered one has been by psychiatric or emotional problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score of Psychiatric Status Subscale Within Addiction Severity Index (ASI) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '.2', 'spread': '.21', 'groupId': 'OG000'}, {'value': '.2', 'spread': '.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'The Psychiatric Status Subscale within ASI is one question that asks how bothered one has been by psychiatric or emotional problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score on EuroQOL EQ-5D Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '1.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'Problems related to drug abuse is assessed through this questionnaire, which consists of 5 conditions. Each condition is scored from 0-2 for a total score range of 0-10. The higher the score, the more problems.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Score on EuroQOL EQ-5D Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '1.15', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '1.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'Problems related to drug abuse is assessed through this questionnaire, which consists of 5 conditions. Each condition is scored from 0-2 for a total score range of 0-10. The higher the score, the more problems.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Alcohol Use Over Time, Drinks Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '.1', 'spread': '.82', 'groupId': 'OG000'}, {'value': '.4', 'spread': '1.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'Alcohol use over time, drinks per day', 'unitOfMeasure': 'drinks per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Other Drug Use Over Time, Cannabis, W0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 0', 'description': 'Other drug use over time measuring cannabis at week 0', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Other Drug Use Over Time, Cannabis, W24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 24', 'description': 'Other drug use over time measuring cannabis at week 24', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Other Drug Use Over Time, Cocaine, W0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 0', 'description': 'Other drug use over time measuring cocaine at week 0', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Other Drug Use Over Time, Cocaine, W24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 24', 'description': 'Other drug use over time measuring cocaine at week 0', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Other Drug Use Over Time, Stimulant, W0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 0', 'description': 'Other drug use over time measuring stimulant (cocaine, crack and amphetamine) at week 0', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Other Drug Use Over Time, Stimulant, W24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '287', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'OG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'week 24', 'description': 'Other drug use over time measuring stimulant (cocaine, crack and amphetamine) at week 24', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'FG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '283'}, {'groupId': 'FG001', 'numSubjects': '287'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '205'}, {'groupId': 'FG001', 'numSubjects': '225'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '62'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'BG000'}, {'value': '287', 'groupId': 'BG001'}, {'value': '570', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)\n\nExtended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)'}, {'id': 'BG001', 'title': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)\n\nBuprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.0', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '33.7', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '33.9', 'spread': '9.63', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '195', 'groupId': 'BG000'}, {'value': '206', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '238', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '471', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '206', 'groupId': 'BG000'}, {'value': '215', 'groupId': 'BG001'}, {'value': '421', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Randomization status', 'classes': [{'title': 'Early randomization', 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}]}, {'title': 'Late randomization', 'categories': [{'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '353', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Adults with DSM-5 OUD with non prescribed opioid use in the past 30 days.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-08-31', 'size': 16187946, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2017-10-30T16:34', 'hasProtocol': True}, {'date': '2017-04-27', 'size': 6664705, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2017-11-01T11:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 570}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-30', 'studyFirstSubmitDate': '2013-12-30', 'resultsFirstSubmitDate': '2017-11-24', 'studyFirstSubmitQcDate': '2014-01-08', 'lastUpdatePostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-20', 'studyFirstPostDateStruct': {'date': '2014-01-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Relapse (Intent to Treat Population)', 'timeFrame': 'Weeks 3-24', 'description': 'Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week.'}, {'measure': 'Time to Relapse (Per Protocol Population)', 'timeFrame': 'Weeks 3-24', 'description': 'Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week.'}], 'secondaryOutcomes': [{'measure': 'Number Successfully Inducted Onto Assigned Study Medication', 'timeFrame': 'Weeks 0-24', 'description': 'Binary Y/N assessment of whether the participant was or was not able to initiate their assigned study medication.'}, {'measure': 'Adverse Events Related to Study Medications', 'timeFrame': 'Weeks 0-36', 'description': 'Adverse events reported by participants and assessed by clinical staff for relatedness to study medication. These determinations were reviewed by the study medical monitor.'}, {'measure': 'Opioid Abstinence Over Time While on Study Medication (Subjective)', 'timeFrame': 'Weeks 0-24', 'description': 'Self report of opioid use by participants using the TLFB. At each visit, the TLFB was completed for dates going back to the last participant encounter.'}, {'measure': 'Alcohol Use Over Time, Drinks Per Day, Past 30 Days, W0', 'timeFrame': 'Week 0', 'description': 'Alcohol use over time, drinks per day, past 30 days, at week 0'}, {'measure': 'Cigarette Smoking, W0, 10 or Less', 'timeFrame': 'Week 0', 'description': 'Participants average cigarettes/day, in past 4 weeks, at week 0, equals 10 or less.'}, {'measure': 'Opioid Craving Over Time W0', 'timeFrame': 'Week 0', 'description': 'Opioid craving over time via VAS at week 0'}, {'measure': 'Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale', 'timeFrame': 'Week 0', 'description': 'The Subacute Withdrawal Symptoms Subscale consists of 6 symptoms. Classification of symptoms can be scored as: 0 - absent, 1 - doubtful or trivial, 2 - present. The total range of scores is 0 - 12, and the higher the total score the more severe the depression.'}, {'measure': 'Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale', 'timeFrame': 'Week 0', 'description': 'The Alcohol Subscale within ASI is one question that asks how bothered one has been by alcohol problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.'}, {'measure': 'Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS)', 'timeFrame': 'Week 0', 'description': 'The Sexual Behavior Subscale consists of 5 questions. Each question is scored from 0-5, for a total score range of 0-25. Higher scores indicate a greater degree of risk-taking behavior.'}, {'measure': 'Score on Trail Making Test Part A', 'timeFrame': 'Week 0', 'description': 'Trail Making Test Part A consists of 25 circles distributed over a sheet of paper. The circles are number 1-25, and the patient is asked to draw lines to connect the numbers in ascending order. The patient is instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Higher scores reveal greater impairment.'}, {'measure': 'Opioid Abstinence Over Time While on Study Medication (Objective)', 'timeFrame': 'Weeks 0-24', 'description': 'A urine sample was obtained and tested for opioids at each in person visit; screening, prior to induction onto study medication, weekly through week 24 and at each of the follow up visits.'}, {'measure': 'Cigarette Smoking, W0 0', 'timeFrame': 'Week 0', 'description': 'Participants average cigarettes/day, in past 4 weeks, at week 0, equals none'}, {'measure': 'Cigarette Smoking, W0 11-20', 'timeFrame': 'Week 0', 'description': 'Participants average cigarettes/day, in past 4 weeks, at week 0, equals 11-20.'}, {'measure': 'Cigarette Smoking, W0 21-30', 'timeFrame': 'Week 0', 'description': 'Participants average cigarettes/day, in past 4 weeks, at week 0, equals 21-30'}, {'measure': 'Cigarette Smoking, W0 31 or More', 'timeFrame': 'Week 0', 'description': 'Participants average cigarettes/day, in past 4 weeks, at week 0, equals 31 or more'}, {'measure': 'Cigarette Smoking, W24 0', 'timeFrame': 'Week 24', 'description': 'Participants average cigarettes/day, in past 4 weeks, at week 24, equals none'}, {'measure': 'Cigarette Smoking', 'timeFrame': 'Week 24', 'description': 'Participants average cigarettes/day, in past 4 weeks, at week 24, equals 10 or less.'}, {'measure': 'Cigarette Smoking, W24 11-20', 'timeFrame': 'Week 24', 'description': 'Participants average cigarettes/day, in past 4 weeks, at week 24, equals 11-20.'}, {'measure': 'Cigarette Smoking, W24 21-30', 'timeFrame': 'Week 24', 'description': 'Participants average cigarettes/day, in past 4 weeks, at week 24, equals 21-30'}, {'measure': 'Cigarette Smoking, W24 31 or More', 'timeFrame': 'Week 24', 'description': 'Participants average cigarettes/day, in past 4 weeks, at week 24, equals 31 or more'}, {'measure': 'Score on Opioid Craving Scale (OCS)', 'timeFrame': 'Week 24', 'description': 'OCS is a brief 3-item measure used to measure opioid craving. The scale consists of 3 items rated on a visual analogue scale (VAS) from 1-10. The total range of score is 0-30, and a higher score indicates a stronger craver / desire to use opiates.'}, {'measure': 'Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale', 'timeFrame': 'Week 24', 'description': 'The Subacute Withdrawal Symptoms Subscale consists of 6 symptoms. Classification of symptoms can be scored as: 0 - absent, 1 - doubtful or trivial, 2 - present. The total range of scores is 0 - 12, and the higher the total score the more severe the depression.'}, {'measure': 'Score on Subjective Opiate Withdrawal Scale (SOWS)', 'timeFrame': 'Week 0', 'description': 'The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). The total range of scores is 0-64; the higher the score, the more intense the withdrawal.'}, {'measure': 'Score on Subjective Opiate Withdrawal Scale (SOWS)', 'timeFrame': 'Week 24', 'description': 'The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). The total range of scores is 0-64; the higher the score, the more intense the withdrawal.'}, {'measure': 'Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS)', 'timeFrame': 'Week 24', 'description': 'The Sexual Behavior Subscale consists of 5 questions. Each question is scored from 0-5, for a total score range of 0-25. Higher scores indicate a greater degree of risk-taking behavior.'}, {'measure': 'Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS)', 'timeFrame': 'Week 0', 'description': 'The Sexual Behavior Subscale consists of 3 questions. Each question is scored from 0-5, for a total score range of 0-15. Higher scores indicate a greater degree of risk-taking behavior.'}, {'measure': 'Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS)', 'timeFrame': 'Week 24', 'description': 'The Sexual Behavior Subscale consists of 3 questions. Each question is scored from 0-5, for a total score range of 0-15. Higher scores indicate a greater degree of risk-taking behavior.'}, {'measure': 'Score on Trail Making Test Part A', 'timeFrame': 'Week 24', 'description': 'Trail Making Test Part A consists of 25 circles distributed over a sheet of paper. The circles are number 1-25, and the patient is asked to draw lines to connect the numbers in ascending order. The patient is instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Higher scores reveal greater impairment.'}, {'measure': 'Score on Trail Making Test Part B', 'timeFrame': 'Week 0', 'description': 'Part B consists of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1-13) and letters (A-L); the patient draws lines to connect the circles in an ascending pattern, by alternating between the numbers and letters. Results are reported as the number of seconds required to complete the task.'}, {'measure': 'Score on Trail Making Test Part B', 'timeFrame': 'Week 24', 'description': 'Part B consists of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1-13) and letters (A-L); the patient draws lines to connect the circles in an ascending pattern, by alternating between the numbers and letters. Results are reported as the number of seconds required to complete the task.'}, {'measure': 'Score on Word Card of Stoop Test', 'timeFrame': 'Week 0', 'description': 'The "word card" of the Stoop Test has the names of colors printed in black and white (100 items to be named). The patient\'s basic score is the total time he/she takes to utter the 100 words on the card.'}, {'measure': 'Score on Word Card of Stoop Test', 'timeFrame': 'Week 24', 'description': 'The "word card" of the Stoop Test has the names of colors printed in black and white (100 items to be named). The patient\'s basic score is the total time he/she takes to utter the 100 words on the card.'}, {'measure': 'Score on Color Card of Stoop Test', 'timeFrame': 'Week 0', 'description': 'The "color card" contains 100 patches of between 3-5 different colors. The patient\'s task is to utter the names of the colored patches as rapidly as possible, scanning the rows from left to right. The score is the total time (in seconds) it takes to utter the 100 colors.'}, {'measure': 'Score on Color Card of Stoop Test', 'timeFrame': 'Week 24', 'description': 'The "color card" contains 100 patches of between 3-5 different colors. The patient\'s task is to utter the names of the colored patches as rapidly as possible, scanning the rows from left to right. The score is the total time (in seconds) it takes to utter the 100 colors.'}, {'measure': 'Score on Color Word Card of Stoop Test', 'timeFrame': 'Week 0', 'description': 'The "color-word card" contains the printed names of colors, but printed in an ink of a conflicting color (e.g. the word RED might be printed in green, yellow, or blue). The patient is required to name the colors of the inks while ignoring the conflicting printed color names. The basic score is the total time (in seconds) to utter the 100 colors.'}, {'measure': 'Score on Color Word Card of Stoop Test', 'timeFrame': 'Week 24', 'description': 'The "color-word card" contains the printed names of colors, but printed in an ink of a conflicting color (e.g. the word RED might be printed in green, yellow, or blue). The patient is required to name the colors of the inks while ignoring the conflicting printed color names. The basic score is the total time (in seconds) to utter the 100 colors.'}, {'measure': 'Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale', 'timeFrame': 'Week 24', 'description': 'The Alcohol Subscale within ASI is one question that asks how bothered one has been by alcohol problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.'}, {'measure': 'Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale', 'timeFrame': 'Week 0', 'description': 'The Drug Use Subscale within ASI is one question that asks how bothered one has been by drug use problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.'}, {'measure': 'Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale', 'timeFrame': 'Week 24', 'description': 'The Drug Use Subscale within ASI is one question that asks how bothered one has been by drug use problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.'}, {'measure': 'Score of Social Relationship Subscale Within Addiction Severity Index (ASI) Scale', 'timeFrame': 'Week 0', 'description': 'The Social Relationship Subscale within ASI contains 2 questions that ask how bothered one has been by family or social problems. The total range of the subscale is 0-8. The higher the score, the bigger the problem.'}, {'measure': 'Score of Family / Social Relationship Subscale Within Addiction Severity Index (ASI) Scale', 'timeFrame': 'Week 24', 'description': 'The Family / Social Relationship Subscale within ASI contains 2 questions that ask how bothered one has been by family or social problems. The total range of the subscale is 0-8. The higher the score, the bigger the problem.'}, {'measure': 'Score of Legal Status Subscale Within Addiction Severity Index (ASI) Scale', 'timeFrame': 'Week 0', 'description': 'The Legal Status Subscale within ASI is one question that asks how bothered one has been by legal problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.'}, {'measure': 'Score of Legal Status Subscale Within Addiction Severity Index (ASI) Scale', 'timeFrame': 'Week 24', 'description': 'The Legal Status Subscale within ASI is one question that asks how bothered one has been by legal problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.'}, {'measure': 'Score of Medical Status Subscale Within Addiction Severity Index (ASI) Scale', 'timeFrame': 'Week 0', 'description': 'The Medical Status Subscale within ASI is one question that asks how bothered one has been by medical problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.'}, {'measure': 'Score of Medical Status Subscale Within Addiction Severity Index (ASI) Scale', 'timeFrame': 'Week 24', 'description': 'The Medical Status Subscale within ASI is one question that asks how bothered one has been by medical problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.'}, {'measure': 'Score of Psychiatric Status Subscale Within Addiction Severity Index (ASI) Scale', 'timeFrame': 'Week 0', 'description': 'The Psychiatric Status Subscale within ASI is one question that asks how bothered one has been by psychiatric or emotional problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.'}, {'measure': 'Score of Psychiatric Status Subscale Within Addiction Severity Index (ASI) Scale', 'timeFrame': 'Week 24', 'description': 'The Psychiatric Status Subscale within ASI is one question that asks how bothered one has been by psychiatric or emotional problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.'}, {'measure': 'Score on EuroQOL EQ-5D Questionnaire', 'timeFrame': 'Week 0', 'description': 'Problems related to drug abuse is assessed through this questionnaire, which consists of 5 conditions. Each condition is scored from 0-2 for a total score range of 0-10. The higher the score, the more problems.'}, {'measure': 'Score on EuroQOL EQ-5D Questionnaire', 'timeFrame': 'Week 24', 'description': 'Problems related to drug abuse is assessed through this questionnaire, which consists of 5 conditions. Each condition is scored from 0-2 for a total score range of 0-10. The higher the score, the more problems.'}, {'measure': 'Alcohol Use Over Time, Drinks Per Day', 'timeFrame': 'Week 24', 'description': 'Alcohol use over time, drinks per day'}, {'measure': 'Other Drug Use Over Time, Cannabis, W0', 'timeFrame': 'week 0', 'description': 'Other drug use over time measuring cannabis at week 0'}, {'measure': 'Other Drug Use Over Time, Cannabis, W24', 'timeFrame': 'week 24', 'description': 'Other drug use over time measuring cannabis at week 24'}, {'measure': 'Other Drug Use Over Time, Cocaine, W0', 'timeFrame': 'week 0', 'description': 'Other drug use over time measuring cocaine at week 0'}, {'measure': 'Other Drug Use Over Time, Cocaine, W24', 'timeFrame': 'week 24', 'description': 'Other drug use over time measuring cocaine at week 0'}, {'measure': 'Other Drug Use Over Time, Stimulant, W0', 'timeFrame': 'week 0', 'description': 'Other drug use over time measuring stimulant (cocaine, crack and amphetamine) at week 0'}, {'measure': 'Other Drug Use Over Time, Stimulant, W24', 'timeFrame': 'week 24', 'description': 'Other drug use over time measuring stimulant (cocaine, crack and amphetamine) at week 24'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['extended-release naltrexone (Vivitrol)', 'buprenorphine-naloxone (Suboxone)', 'comparative effective', 'relapse prevention'], 'conditions': ['Opioid Use Disorder']}, 'referencesModule': {'references': [{'pmid': '40342086', 'type': 'DERIVED', 'citation': 'Kornor H, Lobmaier PPK, Kunoe N. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2025 May 9;5(5):CD006140. doi: 10.1002/14651858.CD006140.pub3.'}, {'pmid': '38616571', 'type': 'DERIVED', 'citation': 'Brandt L, Odom GJ, Hu MC, Castro C, Balise RR; CTN-0094 Team. Empirically contrasting urine drug screening-based opioid use disorder treatment outcome definitions. Addiction. 2024 Jul;119(7):1289-1300. doi: 10.1111/add.16494. Epub 2024 Apr 14.'}, {'pmid': '37712113', 'type': 'DERIVED', 'citation': 'Foot C, Korthuis PT, Tsui JI, Luo SX, Chan B, Cook RR. Associations between stimulant use and return to illicit opioid use following initiation onto medication for opioid use disorder. Addiction. 2024 Jan;119(1):149-157. doi: 10.1111/add.16334. Epub 2023 Sep 15.'}, {'pmid': '36063082', 'type': 'DERIVED', 'citation': 'Nielsen S, Tse WC, Larance B. Opioid agonist treatment for people who are dependent on pharmaceutical opioids. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD011117. doi: 10.1002/14651858.CD011117.pub3.'}, {'pmid': '35605529', 'type': 'DERIVED', 'citation': 'Tsui JI, Campbell ANC, Pavlicova M, Choo TH, Lee JD, Cook RR, Shulman M, Nunes EV, Rotrosen J. Methamphetamine/amphetamine use over time among persons with opioid use disorders treated with buprenorphine/naloxone versus extended-release naltrexone. Drug Alcohol Depend. 2022 Jul 1;236:109469. doi: 10.1016/j.drugalcdep.2022.109469. Epub 2022 Apr 21.'}, {'pmid': '35452195', 'type': 'DERIVED', 'citation': 'Jelovac A, McLoughlin DM. Twelve-Month Outcomes for Remitters Following Electroconvulsive Therapy for Depression. J Clin Psychiatry. 2022 Apr 18;83(3):21lr14371. doi: 10.4088/JCP.21lr14371. No abstract available.'}, {'pmid': '35452194', 'type': 'DERIVED', 'citation': 'Na PJ, Scodes J, Fishman M, Rotrosen J, Nunes EV. Co-occurring Depression and Suicidal Ideation in Opioid Use Disorder: Prevalence and Response During Treatment With Buprenorphine-Naloxone and Injection Naltrexone. J Clin Psychiatry. 2022 Apr 18;83(3):21m14140. doi: 10.4088/JCP.21m14140.'}, {'pmid': '34338389', 'type': 'DERIVED', 'citation': 'Rudolph KE, Shulman M, Fishman M, Diaz I, Rotrosen J, Nunes EV. Association between dynamic dose increases of buprenorphine for treatment of opioid use disorder and risk of relapse. Addiction. 2022 Mar;117(3):637-645. doi: 10.1111/add.15654. Epub 2021 Oct 1.'}, {'pmid': '34170188', 'type': 'DERIVED', 'citation': 'Nunes EV Jr, Scodes JM, Pavlicova M, Lee JD, Novo P, Campbell ANC, Rotrosen J. Sublingual Buprenorphine-Naloxone Compared With Injection Naltrexone for Opioid Use Disorder: Potential Utility of Patient Characteristics in Guiding Choice of Treatment. Am J Psychiatry. 2021 Jul;178(7):660-671. doi: 10.1176/appi.ajp.2020.20060816. Epub 2021 Jun 25.'}, {'pmid': '34075644', 'type': 'DERIVED', 'citation': 'Fishman M, Wenzel K, Scodes J, Pavlicova M, Campbell ANC, Rotrosen J, Nunes E. Examination of Correlates of OUD Outcomes in Young Adults: Secondary Analysis From the XBOT Trial. Am J Addict. 2021 Sep;30(5):433-444. doi: 10.1111/ajad.13176. Epub 2021 Jun 1.'}, {'pmid': '33771287', 'type': 'DERIVED', 'citation': 'Shulman M, Choo TH, Scodes J, Pavlicova M, Wai J, Haenlein P, Tofighi B, Campbell ANC, Lee JD, Rotrosen J, Nunes EV. Association between methadone or buprenorphine use during medically supervised opioid withdrawal and extended-release injectable naltrexone induction failure. J Subst Abuse Treat. 2021 May;124:108292. doi: 10.1016/j.jsat.2021.108292. Epub 2021 Jan 16.'}, {'pmid': '29150198', 'type': 'DERIVED', 'citation': 'Lee JD, Nunes EV Jr, Novo P, Bachrach K, Bailey GL, Bhatt S, Farkas S, Fishman M, Gauthier P, Hodgkins CC, King J, Lindblad R, Liu D, Matthews AG, May J, Peavy KM, Ross S, Salazar D, Schkolnik P, Shmueli-Blumberg D, Stablein D, Subramaniam G, Rotrosen J. Comparative effectiveness of extended-release naltrexone versus buprenorphine-naloxone for opioid relapse prevention (X:BOT): a multicentre, open-label, randomised controlled trial. Lancet. 2018 Jan 27;391(10118):309-318. doi: 10.1016/S0140-6736(17)32812-X. Epub 2017 Nov 14.'}, {'pmid': '27521809', 'type': 'DERIVED', 'citation': 'Lee JD, Nunes EV, Mpa PN, Bailey GL, Brigham GS, Cohen AJ, Fishman M, Ling W, Lindblad R, Shmueli-Blumberg D, Stablein D, May J, Salazar D, Liu D, Rotrosen J. NIDA Clinical Trials Network CTN-0051, Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment (X:BOT): Study design and rationale. Contemp Clin Trials. 2016 Sep;50:253-64. doi: 10.1016/j.cct.2016.08.004. Epub 2016 Aug 10.'}]}, 'descriptionModule': {'briefSummary': 'CTN-0051 assesses the comparative effectiveness of extended release injectable naltrexone (XR-NTX, Vivitrol®), an opioid antagonist recently approved and indicated for the prevention of relapse to opioid dependence, versus buprenorphine-naloxone (BUP-NX, Suboxone®), a high affinity partial agonist indicated for maintenance treatment of opioid dependence, as pharmacotherapeutic aids to recovery.\n\nThe study is conducted in 8 NIDA Clinical Trials Network affiliated community based treatment programs. Up to 600 eligible participants will be randomized to treatment with XR-NTX or BUP-NX for 24 weeks (sufficient to include 350 participants who are randomized more than 72 hours after their last opioid).\n\nThe primary goal of the study is to estimate the difference, if one exists, between XR-NTX and BUP-NX in the distribution of the time to relapse (i.e.., loss of persistent abstinence) during the 6-month trial. Secondary objectives are to: (1) compare outcome on XR-NTX versus BUP-NX across a range of clinical safety and secondary efficacy domains, and (2) explore demographic and, clinical, and genetic predictors of successful treatment and moderators of differential effectiveness (i.e., what variables may help clinicians choose which of these treatments is best for a given patient).), and (3) collect a limited dataset to permit analyses of economic costs and benefits of the two treatments.', 'detailedDescription': 'For opioid-dependent patients in the U.S. and most of the rest of the world, detoxification or detoxification followed by short term residential treatment, with the goal of achieving long-term abstinence from opioid misuse is a mainstay of treatment. Nonetheless, the majority of patients treated in this way will relapse to opioid misuse, leading to a costly and ineffectual cycle of readmission for repeated detoxifications.\n\nThe overarching goal of CTN-0051 is to foster adoption of new relapse-prevention pharmacotherapies in community-based treatment programs (CTPs) where these could have a substantial public health impact. To this end CTN-0051 assesses the comparative effectiveness of extended release injectable naltrexone (XR-NTX, Vivitrol®), an opioid antagonist recently approved and indicated for the prevention of relapse to opioid dependence, versus buprenorphine-naloxone (BUP-NX, Suboxone®), a high affinity partial agonist indicated for maintenance treatment of opioid dependence, as pharmacotherapeutic aids to recovery.\n\nThe study is conducted in 8 CTN-affiliated CTPs that provide or partner with detoxification services (inpatient/residential) which have the capacity to maintain participants opioid-free for approximately 3-7 days, have the capacity to provide medication-assisted therapy, and can provide a minimum of one group or individual counseling session per week during the 24-week treatment period. Up to 600 eligible participants will be randomized to treatment with XR-NTX or BUP-NX for 24 weeks (sufficient to include 350 participants who are randomized more than 72 hours after their last opioid). To maximize generalizability, the point of randomization is flexible, from shortly after program admission until just prior to program discharge. A data analysis modification (assessment of whether the early vs. late randomizers have a differential treatment effect and if so, time to relapse will be estimated for early and late randomizers separately) will occur if differential treatment initiation is a problem for cases randomized prior to completing detoxification (i.e., significantly fewer early randomizers are able to complete detoxification and XR-NTX induction).\n\nThe primary goal of the study is to estimate the difference, if one exists, between XR-NTX and BUP-NX in the distribution of the time to relapse (i.e., loss of persistent abstinence) during the 6-month trial. The primary outcome measure will be the time to the event, with the event called relapse. Secondary objectives are to: (1) compare outcome on XR-NTX versus BUP-NX across a range of clinical safety and secondary efficacy domains, and (2) explore demographic and, clinical, and genetic predictors of successful treatment and moderators of differential effectiveness (i.e., what variables may help clinicians choose which of these treatments is best for a given patient), and (3) collect a limited dataset to permit analyses of economic costs and benefits of the two treatments.\n\nToward the end of the 24-week treatment period, participants are referred for follow-up care in the community (which could include pharmacotherapy if desired and available), and follow-up outcomes are assessed at week 28 and week 36 after randomization. For participants receiving BUP-NX, who do not wish to continue, or for whom community resources are not available, the study provides a two-week BUP-NX taper.\n\nIn an ancillary genetics study we plan to study functional variants in three genes (OPRM1, OPRK1 and PDYN), known to affect the dynamic response to opioid receptor ligands. These variants will be evaluated in CTN-0051 for their contribution to treatment retention, abstinence, and depression. Blood collection for DNA extraction will occur at the same time that blood is collected for medical safety and liver function evaluation, precluding the need for an additional needle-stick. Coded blood samples for the genetics studies will be sent to the NIDA Center for Genetics Repository.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Male or female\n* 18 years of age and older\n* Meet DSM-5 criteria for opioid-use disorder (heroin and/or prescription opioids)\n* Have used opioids other than as specifically prescribed within thirty days prior to consent\n* Seeking treatment for opioid dependence and willing to accept "agonist-based" or "antagonist-based" therapy\n* In good-enough general health, as determined by the study physician on the basis of medical history, review of systems, physical exam and laboratory assessments, to permit treatment with XR-NTX or BUP-NX\n* Able to provide written informed consent\n* Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study\n* If female of childbearing potential, be willing to practice an effective method of birth control for the duration of participation in the study\n\nExclusion Criteria\n\n* Serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make study participation hazardous to the participant, or compromise study findings or would prevent the participant from completing the study. Examples include:\n\n 1. Disabling or terminal medical illness (e.g., uncompensated heart failure, cirrhosis or end-stage liver disease) as assessed by medical history, review of systems, physical exam and/or laboratory assessments;\n 2. Severe, untreated or inadequately treated mental disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and/or clinical interview;\n 3. Current severe alcohol, benzodiazepine, or other depressant or sedative hypnotic use likely to require a complicated medical detoxification (routine alcohol and sedative detoxifications may be included)\n* LFTs (ALT, AST) greater than 5 times upper limit of normal\n* Suicidal or homicidal ideation that requires immediate attention\n* Known allergy or sensitivity to buprenorphine, naloxone, naltrexone, polylactide-co-glycolide, carboxymethylcellulose, or other components of the Vivitrol® diluent\n* Maintenance on methadone at doses of 30mg or greater at the time of signing consent\n* Presence of pain of sufficient severity as to require ongoing pain management with opioids\n* Pending legal action or other reasons that might prevent an individual from completing the study\n* If female, currently pregnant or breastfeeding, or planning on conception\n* Body habitus that, in the judgment of the study physician, precludes safe intramuscular injection of XR-NTX (e.g., BMI\\>40, excess fat tissue over the buttocks, emaciation)'}, 'identificationModule': {'nctId': 'NCT02032433', 'briefTitle': 'Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'CTN-0051: Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment', 'orgStudyIdInfo': {'id': '12-03133'}, 'secondaryIdInfos': [{'id': 'UG1DA013035', 'link': 'https://reporter.nih.gov/quickSearch/UG1DA013035', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Extended-Release Naltrexone', 'description': 'Extended-Release Naltrexone (Vivitrol)', 'interventionNames': ['Drug: Extended-Release Naltrexone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Buprenorphine-Naloxone', 'description': 'Buprenorphine-Naloxone (Suboxone)', 'interventionNames': ['Drug: Buprenorphine-Naloxone']}], 'interventions': [{'name': 'Extended-Release Naltrexone', 'type': 'DRUG', 'otherNames': ['Vivitrol®'], 'description': 'Extended-Release Naltrexone (Vivitrol®)', 'armGroupLabels': ['Extended-Release Naltrexone']}, {'name': 'Buprenorphine-Naloxone', 'type': 'DRUG', 'otherNames': ['Suboxone®'], 'description': 'Buprenorphine-Naloxone (Suboxone®)', 'armGroupLabels': ['Buprenorphine-Naloxone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91356', 'city': 'Tarzana', 'state': 'California', 'country': 'United States', 'facility': 'Tarzana Treatment Centers', 'geoPoint': {'lat': 34.17334, 'lon': -118.55397}}, {'zip': '32201', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Gateway Community Services, Inc.', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '20853', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Avery Road Treatment Center', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '02720', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Stanley Street Treatment and Resources', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '87108', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Turquoise Lodge Hospital', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Bellevue Hospital Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43207', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Maryhaven', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '98134', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Evergreen Treatment Services', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'John Rotrosen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data from this study will be available to researchers on the website, http://datashare.nida.nih.gov/ after the study is complete and the data analyzed. This website will not include information that can identify individual study participants.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'The Emmes Company, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}