Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT00678418
Status:
COMPLETED
Last Update Posted:
2017-02-10
First Post:
2008-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}, {'id': 'D006556', 'term': 'Heroin Dependence'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000624616', 'term': 'vivitrol'}, {'id': 'D009271', 'term': 'Naltrexone'}], 'ancestors': [{'id': 'D009270', 'term': 'Naloxone'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bernard.silverman@alkermes.com', 'phone': '1-781-609-6000', 'title': 'Bernard L. Silverman, MD', 'organization': 'Alkermes, Inc.'}, 'certainAgreement': {'otherDetails': "No individual investigator may publish results until after the publication of the overall study without receiving Alkermes' written approval. After that time, a PI/Institution may publish results for noncommercial purposes. Should an investigator wish to do so, the Sponsor will have 30 days to review the proposed publication. The PI/Institution will delete any Sponsor Confidential Information other than study results and will revise a publication based on regulatory requirements of the Sponsor.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '6 Months (Part A)', 'description': 'All participants who received at least 1 dose of randomized, double-blinded study drug (VIVITROL or placebo) are included in the safety population for Part A. Adverse events were tallied by number of participants affected as opposed to number of incidences reported for a given preferred term.', 'eventGroups': [{'id': 'EG000', 'title': 'VIVITROL® 380 mg', 'description': 'Single intramuscular (IM) injection administered every 4 weeks', 'otherNumAtRisk': 126, 'otherNumAffected': 63, 'seriousNumAtRisk': 126, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Single intramuscular (IM) injection administered every 4 weeks', 'otherNumAtRisk': 124, 'otherNumAffected': 40, 'seriousNumAtRisk': 124, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Gamma-glutamyl transferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Drug dependence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Pharyngolarnygeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Protein total increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'seriousEvents': [{'term': 'Acquired immunodeficiency syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Adnexitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'HIV infection WHO clinical stage III', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Herpes virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Drug dependence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}, {'term': 'Peptic ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.1)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage (%) of Opioid-free Weeks Per Subject in Double-blind Period (Part A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VIVITROL® 380 mg', 'description': 'Single intramuscular (IM) injection administered every 4 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single intramuscular (IM) injection administered every 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '90.0', 'spread': '40.1', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '100.0'}, {'value': '35.0', 'spread': '43.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '95.0'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis = the distribution function of opioid-free weeks is the same for both treatment groups.', 'statisticalMethod': 'Van der Waerden', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '20 weeks', 'description': "Included are data from the last 20 weeks of the 24-week double-blind treatment period (Part A). Response profiles for each Arm are based on subjects' individual rates of weekly opioid-free data, including negative urine test results, attendance at study visits, and self-reports of opioid use/non-use.", 'unitOfMeasure': 'Percentage of opioid-free weeks', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses include all randomized subjects who received at least 1 dose of study drug (Intent-to-treat \\[ITT\\] population).'}, {'type': 'SECONDARY', 'title': 'Days to Discontinuation During Part A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VIVITROL® 380 mg', 'description': 'Single intramuscular (IM) injection administered every 4 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single intramuscular (IM) injection administered every 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median estimate for VIVITROL is \\>168 days (the duration of the treatment period). The median and confidence interval cannot be estimated because less than 50% of VIVITROL subjects discontinued during the 168-day treatment period.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '96.0', 'groupId': 'OG001', 'lowerLimit': '63.0', 'upperLimit': '165.0'}]}]}], 'analyses': [{'pValue': '0.0042', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'A total of 114 subjects continued on-study beyond the 168-day endpoint for Part A; these subjects were censored as of the first dosing day in Part B.', 'groupDescription': 'P-value was calculated using the log-rank test for the null hypothesis: the distribution of days to discontinuation does not differ by treatment.', 'statisticalMethod': 'Kaplan Meier', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '168 days (24 weeks)', 'description': 'Defined as the duration of study participation and calculated as the number of days from Dose 1 to the day of study discontinuation.', 'unitOfMeasure': 'Days to study discontinuation', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses include all randomized subjects who received at least 1 dose of study drug (ITT population).'}, {'type': 'SECONDARY', 'title': 'Craving Score: Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VIVITROL® 380 mg', 'description': 'Single intramuscular (IM) injection administered every 4 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single intramuscular (IM) injection administered every 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.087', 'groupId': 'OG000', 'lowerLimit': '-12.333', 'upperLimit': '-7.840'}, {'value': '0.654', 'groupId': 'OG001', 'lowerLimit': '-3.139', 'upperLimit': '4.446'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'groupDescription': 'P-value was calculated using the Chi-square test for the null hypothesis: mean treatment difference = 0.\n\nCalculations were based on the Generalized Estimating Equation (GEE) model (normal distribution, identity link and AR(1) correlation structure) for repeated data on change from baseline with treatment and visit as main effects, and baseline as a covariate. Missing data were imputed using the Last Observation Carried Forward (LOCF) method.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 6 months (24 weeks)', 'description': 'Measured using subjects\' response on a validated Visual Analog Scale at prespecified weekly visits throughout Part A, with comparison of baseline to end of Part A. The scale ranged from 0 ("No craving") to 100 ("highest possible craving").', 'unitOfMeasure': 'Units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses include all randomized subjects who received at least 1 dose of study drug (ITT population).'}, {'type': 'SECONDARY', 'title': 'Incidence of Subjects Who Relapsed to Physiologic Opioid Dependence During the 24-week Treatment Period (Part A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VIVITROL® 380 mg', 'description': 'Single intramuscular (IM) injection administered every 4 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single intramuscular (IM) injection administered every 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '46.8', 'groupId': 'OG000'}, {'value': '62.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0154', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.60', 'ciUpperLimit': '0.95', 'groupDescription': 'Chi-square test was used to calculate the p-value for treatment. Null hypothesis = no association between relapse to dependence and study treatment.\n\nSubjects who discontinued prematurely from the study were imputed as having a positive naloxone challenge test result.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '24 Weeks', 'description': "Assessment of relapse to physiologic opioid dependence was based on individual subjects' results on the naloxone challenge test. A positive naloxone challenge test result was considered as a relapse to physiologic opioid dependence.", 'unitOfMeasure': 'Percentage of participants who relapsed', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses include all randomized subjects who received at least 1 dose of study drug (ITT population).'}, {'type': 'SECONDARY', 'title': 'Change in Percentage of Self-reported Opioid-free Days From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VIVITROL® 380 mg', 'description': 'Single intramuscular (IM) injection administered every 4 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single intramuscular (IM) injection administered every 4 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '75.83', 'groupId': 'OG000', 'lowerLimit': '32.14', 'upperLimit': '100.00'}, {'value': '46.43', 'groupId': 'OG001', 'lowerLimit': '11.01', 'upperLimit': '96.76'}]}]}], 'analyses': [{'pValue': '0.0031', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Null hypothesis: Treatment difference=0. Missing data from subjects due to early discontinuation during Part A were imputed using the baseline rate; thus data for subjects who discontinued early were imputed as having no change from baseline.', 'statisticalMethod': 'van der Waerden', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '24 Weeks', 'description': "Opioid use was measured using subjects' entries on a validated Timeline FollowBack (TLFB) calendar in which they recorded their use/non-use of opioids each day.", 'unitOfMeasure': 'Percentage of opioid-free days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': "Analyses include all randomized subjects who received at least 1 dose of study drug (ITT population). Change from baseline was calculated per subject as the percent of subjects' self-reported opioid-free days in Part A minus the percent of opioid-free days prior to the subjects' hospitalization for pre-study detoxification."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VIVITROL® 380 mg', 'description': 'Single intramuscular (IM) injection administered every 4 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Single intramuscular (IM) injection administered every 4 weeks'}], 'periods': [{'title': 'Part A (Double Blind)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '124'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '77'}]}]}, {'title': 'Part B (Open Label)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'All participants who received placebo in Part A were switched to open-label VIVITROL in Part B.', 'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'VIVITROL® 380 mg', 'description': 'Single intramuscular (IM) injection administered every 4 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Single intramuscular (IM) injection administered every 4 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.4', 'spread': '4.8', 'groupId': 'BG000'}, {'value': '29.7', 'spread': '3.6', 'groupId': 'BG001'}, {'value': '29.6', 'spread': '4.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-21', 'studyFirstSubmitDate': '2008-05-14', 'resultsFirstSubmitDate': '2010-12-20', 'studyFirstSubmitQcDate': '2008-05-14', 'lastUpdatePostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-12-20', 'studyFirstPostDateStruct': {'date': '2008-05-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage (%) of Opioid-free Weeks Per Subject in Double-blind Period (Part A)', 'timeFrame': '20 weeks', 'description': "Included are data from the last 20 weeks of the 24-week double-blind treatment period (Part A). Response profiles for each Arm are based on subjects' individual rates of weekly opioid-free data, including negative urine test results, attendance at study visits, and self-reports of opioid use/non-use."}], 'secondaryOutcomes': [{'measure': 'Days to Discontinuation During Part A', 'timeFrame': '168 days (24 weeks)', 'description': 'Defined as the duration of study participation and calculated as the number of days from Dose 1 to the day of study discontinuation.'}, {'measure': 'Craving Score: Change From Baseline', 'timeFrame': 'Baseline to 6 months (24 weeks)', 'description': 'Measured using subjects\' response on a validated Visual Analog Scale at prespecified weekly visits throughout Part A, with comparison of baseline to end of Part A. The scale ranged from 0 ("No craving") to 100 ("highest possible craving").'}, {'measure': 'Incidence of Subjects Who Relapsed to Physiologic Opioid Dependence During the 24-week Treatment Period (Part A)', 'timeFrame': '24 Weeks', 'description': "Assessment of relapse to physiologic opioid dependence was based on individual subjects' results on the naloxone challenge test. A positive naloxone challenge test result was considered as a relapse to physiologic opioid dependence."}, {'measure': 'Change in Percentage of Self-reported Opioid-free Days From Baseline to Week 24', 'timeFrame': '24 Weeks', 'description': "Opioid use was measured using subjects' entries on a validated Timeline FollowBack (TLFB) calendar in which they recorded their use/non-use of opioids each day."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Addiction', 'Opiate dependence', 'Inpatient detoxification', 'opioid dependence', 'heroin dependence'], 'conditions': ['Opiate Dependence']}, 'referencesModule': {'references': [{'pmid': '23701526', 'type': 'RESULT', 'citation': 'Krupitsky E, Nunes EV, Ling W, Gastfriend DR, Memisoglu A, Silverman BL. Injectable extended-release naltrexone (XR-NTX) for opioid dependence: long-term safety and effectiveness. Addiction. 2013 Sep;108(9):1628-37. doi: 10.1111/add.12208. Epub 2013 May 24.'}, {'pmid': '25901451', 'type': 'RESULT', 'citation': 'Nunes EV, Krupitsky E, Ling W, Zummo J, Memisoglu A, Silverman BL, Gastfriend DR. Treating Opioid Dependence With Injectable Extended-Release Naltrexone (XR-NTX): Who Will Respond? J Addict Med. 2015 May-Jun;9(3):238-43. doi: 10.1097/ADM.0000000000000125.'}, {'pmid': '23036218', 'type': 'RESULT', 'citation': 'Mitchell MC, Memisoglu A, Silverman BL. Hepatic safety of injectable extended-release naltrexone in patients with chronic hepatitis C and HIV infection. J Stud Alcohol Drugs. 2012 Nov;73(6):991-7. doi: 10.15288/jsad.2012.73.991.'}, {'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': '22945623', 'type': 'DERIVED', 'citation': 'Krupitsky E, Zvartau E, Blokhina E, Verbitskaya E, Wahlgren V, Tsoy-Podosenin M, Bushara N, Burakov A, Masalov D, Romanova T, Tyurina A, Palatkin V, Slavina T, Pecoraro A, Woody GE. Randomized trial of long-acting sustained-release naltrexone implant vs oral naltrexone or placebo for preventing relapse to opioid dependence. Arch Gen Psychiatry. 2012 Sep;69(9):973-81. doi: 10.1001/archgenpsychiatry.2012.1a.'}, {'pmid': '21529928', 'type': 'DERIVED', 'citation': 'Krupitsky E, Nunes EV, Ling W, Illeperuma A, Gastfriend DR, Silverman BL. Injectable extended-release naltrexone for opioid dependence: a double-blind, placebo-controlled, multicentre randomised trial. Lancet. 2011 Apr 30;377(9776):1506-13. doi: 10.1016/S0140-6736(11)60358-9.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 3 multi-center trial designed to evaluate the clinical efficacy and safety of VIVITROL® (Medisorb® naltrexone 380 mg) versus placebo when administered to adults upon discharge from inpatient treatment for opioid dependence.\n\nThe study was conducted in 2 parts, Part A and Part B. The clinical portion of both parts has completed. Results for Part B are not yet available.', 'detailedDescription': "Part A was a double-blind, randomized, placebo-controlled assessment of the efficacy and safety of 24 weeks of monthly treatment with VIVITROL compared to placebo in opioid-dependent adults.\n\nSubjects who completed Part A could choose to continue to Part B, which was an open-label extension to assess longer-term safety, durability of effect, health economics, and quality of life (QOL) in the continuing study population for up to 1 year.\n\nAt the conclusion of both parts, each completing subject will have received a total of up to 19 injections of study drug over approximately 1.5 years.\n\nDosing was performed by the principal investigator or designated study staff member.\n\nAll subjects received standardized, manual-based psychosocial support at each scheduled visit. Opioid use was tracked through urine drug testing and subjects' self reports. Other evaluations for efficacy and safety, health economics, and quality of life were routinely conducted throughout the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Primary Inclusion Criteria:\n\n* Written, informed consent\n* 18 years of age or older\n* Current diagnosis of opioid dependence, based on Diagnostic and Statistical Manual of Mental Health Disorders, 4th Ed. (DSM-IV-TR) criteria\n* Voluntarily seeking treatment for opioid dependence\n* Completing or recently completed up to 30 days of inpatient treatment for opioid detoxification, and off all opioids (including buprenorphine and methadone) for at least 7 days\n* Noncustodial, stable residence and phone, plus 1 contact with verifiable address and phone\n* Significant other (eg, spouse, relative) willing to supervise compliance with the study visit schedule and procedures\n* Agree to use contraception for study duration if of childbearing potential\n\nPrimary Exclusion Criteria:\n\n* Pregnancy or lactation\n* Clinically significant medical condition or observed abnormalities (eg: physical exam, electrocardiogram (ECG), lab and/or urinalysis findings)\n* Positive naloxone challenge test at randomization (Day 0)\n* Evidence of hepatic failure including: ascites, bilirubin \\>10% above upper limit of normal (ULN) and/or esophageal variceal disease\n* Past or present history of an acquired immunodeficiency syndrome (AIDS)-indicator disease in HIV-infected subjects\n* Active hepatitis and/or aspartate aminotransferase (AST), alanine aminotransferase(ALT) \\>3xULN\n* Current major depression with suicidal ideation, psychosis, bipolar disorder, or any psychiatric disorder that would compromise ability to complete the study\n* Recent history (within 6 months prior to screening) of suicidal ideation or attempt\n* Dependence within prior year based on DSM-IV-TR, to any drugs other than prescription opioids or heroin, caffeine, marijuana, or nicotine\n* Active alcohol dependence within prior 6 months\n* Current alcohol use disorder that would, in the Investigator's opinion, preclude successful completion of the study\n* Positive urine drug test for cocaine, benzodiazepines, or amphetamines at screening\n* Use of oral naltrexone for 7 consecutive days within 60 days prior to screening\n* Known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or polylactide-co-glycolide (PLG)"}, 'identificationModule': {'nctId': 'NCT00678418', 'briefTitle': 'ALK21-013: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) in Adults With Opioid Dependence', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alkermes, Inc.'}, 'officialTitle': 'Efficacy and Safety of VIVITROL® (Naltrexone for Extended-release Injectable Suspension) in Adults With Opioid Dependence', 'orgStudyIdInfo': {'id': 'ALK21-013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VIVITROL® 380 mg', 'interventionNames': ['Drug: VIVITROL® 380 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'VIVITROL® 380 mg', 'type': 'DRUG', 'otherNames': ['Naltrexone for extended-release injectable suspension', 'Medisorb® naltrexone'], 'description': 'Administered via intramuscular (IM) injection once every 4 weeks for 24 weeks during Part A, followed by once every 4 weeks for 52 weeks in Part B.', 'armGroupLabels': ['VIVITROL® 380 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered via IM injection once every 4 weeks for 24 weeks during Part A, followed by VIVITROL® 380 mg via IM injection once every 4 weeks for 52 weeks in Part B.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '109074', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Ethics Committee within the Federal Authority for Healthcare and Social Development Regulation', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Evgeny Krupitsky, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leningrad Regional Addiction Center'}, {'name': 'Ruslan Ilyuk, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bekhterev Psychoneurological Research Institute'}, {'name': 'Edvin Zvartau, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint-Petersburg State Medical University n.a. Pavlov'}, {'name': 'Alexander Sofronov, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint-Petersburg Addiction Hospital'}, {'name': 'Alexey Egorov, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint-Petersburg Addiction Hospital'}, {'name': 'Alexander Okhapkin, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Addiction Treatment Center, Clinical Facility of Smolensk State Medical Academy'}, {'name': 'Nikolay Bokhan, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tomsk Mental Health Research Institute'}, {'name': 'Vladimir Mendelevich, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kazan State Medical University'}, {'name': 'Yuri Sivolap, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moscow Medical Academy n.a. I.M. Sechenov'}, {'name': 'Oleg Eryshev, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bekhterev Psychoneurological Research Institute'}, {'name': 'Nikolay Ivanets, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Addiction Scientific Center'}, {'name': 'Vitaliy Sinitskiy, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northern State Medical University'}, {'name': 'Andrey Anipchenko, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint-Petersburg Addiction Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alkermes, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}