Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-01 @ 2:45 AM
Study NCT ID:
NCT01903005
Status:
COMPLETED
Last Update Posted:
2015-10-28
First Post:
2013-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence
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': 'D000069479', 'term': 'Buprenorphine, Naloxone Drug Combination'}, {'id': 'D002047', 'term': 'Buprenorphine'}], 'ancestors': [{'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': 'Suboxdoc1@yahoo.com', 'phone': '(407) 691-3960', 'title': 'Kent Hoffman, DO', 'organization': 'TRY Research'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Day 1 through Week 24 of Open-Label Extension Study', 'description': 'Safety population (N=665)', 'eventGroups': [{'id': 'EG000', 'title': 'Safety Population', 'description': 'Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses of buprenorphine/naloxone between 5.7/1.4 mg and 17.1/4.2 mg mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.', 'otherNumAtRisk': 665, 'otherNumAffected': 41, 'seriousNumAtRisk': 665, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Constipation', 'notes': 'Treatment-emergent.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numEvents': 22, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0.'}, {'term': 'Headache', 'notes': 'Treatment-emergent.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numEvents': 22, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0.'}], 'seriousEvents': [{'term': 'Heroin toxicity', 'notes': 'Condition led to death; non-treatment-emergent; not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0.'}, {'term': 'Hypertensive and atherosclerotic cardiovascular disease', 'notes': 'Condition led to death; non-treatment-emergent, not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0.'}, {'term': 'Non-small cell lung cancer', 'notes': 'Moderate, treatment-emergent; not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0.'}, {'term': 'Respiratory syncytial virus bronchitis', 'notes': 'Moderate, treatment-emergent; not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0.'}, {'term': 'Depression', 'notes': 'Mild, treatment-emergent; not related to study drug in one patient; severe, treatment-emergent; possibly related to study drug in another patient.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0.'}, {'term': 'Chronic obstructive pulmonary disease', 'notes': 'Moderate, treatment-emergent; not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0.'}, {'term': 'Asthma', 'notes': 'Moderate, treatment-emergent; not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0.'}, {'term': 'Anal abscess', 'notes': 'Severe, treatment-emergent; unlikely related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0.'}, {'term': 'Arthropod bite', 'notes': 'Moderate, treatment-emergent; not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0.'}, {'term': 'Overdose', 'notes': 'Severe, treatment-emergent; not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0.'}, {'term': 'Metabolic encephalopathy', 'notes': 'Severe, treatment-emergent; not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0.'}, {'term': 'Urinary tract infection', 'notes': 'Severe, treatment-emergent; not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0.'}, {'term': 'Multiple fractures', 'notes': 'Severe, treatment-emergent; not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0.'}, {'term': 'Intentional overdose', 'notes': 'Severe, non-treatment-emergent; not related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0.'}, {'term': 'Worsening of opioid dependence', 'notes': 'Moderate, non-treatment-emergent; not related to study drug in two patients.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0.'}, {'term': 'Bipolar depression', 'notes': 'Severe, non-treatment-emergent; unlikely related to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 665, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0.'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Retention in Treatment in the Safety Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '665', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Population', 'description': 'Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '563', 'groupId': 'OG000', 'lowerLimit': '545', 'upperLimit': '581'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '483', 'groupId': 'OG000', 'lowerLimit': '460', 'upperLimit': '505'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '425', 'groupId': 'OG000', 'lowerLimit': '401', 'upperLimit': '450'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '383', 'groupId': 'OG000', 'lowerLimit': '358', 'upperLimit': '408'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '333', 'groupId': 'OG000', 'lowerLimit': '308', 'upperLimit': '358'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '292', 'groupId': 'OG000', 'lowerLimit': '267', 'upperLimit': '317'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Treatment retention was assessed at weeks 4, 8, 12, 16, 20, and 24', 'description': 'Retention in treatment by visit in the safety population at weeks 4, 8, 12, 16, 20, and 24, defined as the number of patients receiving treatment on the day of the visit (± 5 days for each visit)', 'unitOfMeasure': 'participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'SECONDARY', 'title': 'Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '665', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Population', 'description': 'Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.'}], 'classes': [{'title': 'Day 1 (n=658)', 'categories': [{'measurements': [{'value': '-12.0', 'groupId': 'OG000', 'lowerLimit': '-12.3', 'upperLimit': '-11.6'}]}]}, {'title': 'Week 4 (n=557)', 'categories': [{'measurements': [{'value': '-12.2', 'groupId': 'OG000', 'lowerLimit': '-12.6', 'upperLimit': '-11.8'}]}]}, {'title': 'Week 8 (n=477)', 'categories': [{'measurements': [{'value': '-12.7', 'groupId': 'OG000', 'lowerLimit': '-13.1', 'upperLimit': '-12.3'}]}]}, {'title': 'Week 12 (n=423)', 'categories': [{'measurements': [{'value': '-12.9', 'groupId': 'OG000', 'lowerLimit': '-13.4', 'upperLimit': '-12.5'}]}]}, {'title': 'Week 16 (n=384)', 'categories': [{'measurements': [{'value': '-13.1', 'groupId': 'OG000', 'lowerLimit': '-13.6', 'upperLimit': '-12.6'}]}]}, {'title': 'Week 20 (n=336)', 'categories': [{'measurements': [{'value': '-13.3', 'groupId': 'OG000', 'lowerLimit': '-13.8', 'upperLimit': '-12.8'}]}]}, {'title': 'Week 24 (completers only; n=288)', 'categories': [{'measurements': [{'value': '-13.1', 'groupId': 'OG000', 'lowerLimit': '-13.7', 'upperLimit': '-12.6'}]}]}, {'title': 'Study Endpoint (n=597)', 'categories': [{'measurements': [{'value': '-12.5', 'groupId': 'OG000', 'lowerLimit': '-12.9', 'upperLimit': '-12.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to dosing on day 1, at weeks 4, 8,12,16, 20, 24, and at study endpoint', 'description': 'Mean change from primary study baseline in COWS total scores during the 24-week open-label, extension study; COWS scores range from 0 to 48, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for COWS', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; patient population at day 1 (n=658) is lower than overall safety population (n=665) due to missing data'}, {'type': 'SECONDARY', 'title': 'Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '665', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Population', 'description': 'Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.'}], 'classes': [{'title': 'Day 1 (n=650)', 'categories': [{'measurements': [{'value': '-26.8', 'groupId': 'OG000', 'lowerLimit': '-27.8', 'upperLimit': '-25.7'}]}]}, {'title': 'Week 4 (n=550)', 'categories': [{'measurements': [{'value': '-27.4', 'groupId': 'OG000', 'lowerLimit': '-28.6', 'upperLimit': '-26.2'}]}]}, {'title': 'Week 8 (n=472)', 'categories': [{'measurements': [{'value': '-28.0', 'groupId': 'OG000', 'lowerLimit': '-29.2', 'upperLimit': '-26.7'}]}]}, {'title': 'Week 12 (n=418)', 'categories': [{'measurements': [{'value': '-27.7', 'groupId': 'OG000', 'lowerLimit': '-29.0', 'upperLimit': '-26.3'}]}]}, {'title': 'Week 16 (n=376)', 'categories': [{'measurements': [{'value': '-28.7', 'groupId': 'OG000', 'lowerLimit': '-30.1', 'upperLimit': '-27.3'}]}]}, {'title': 'Week 20 (n=331)', 'categories': [{'measurements': [{'value': '-28.9', 'groupId': 'OG000', 'lowerLimit': '-30.4', 'upperLimit': '-27.5'}]}]}, {'title': 'Week 24 (n=282)', 'categories': [{'measurements': [{'value': '-27.7', 'groupId': 'OG000', 'lowerLimit': '-29.4', 'upperLimit': '-26.0'}]}]}, {'title': 'Study Endpoint (n=588)', 'categories': [{'measurements': [{'value': '-27.3', 'groupId': 'OG000', 'lowerLimit': '-28.5', 'upperLimit': '-26.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to dosing on day 1, at weeks 4, 8,12,16, 20, and 24, and at study endpoint', 'description': 'Mean change from primary study baseline in SOWS total scores during the 24-week open-label, extension study; SOWS scores range from 0 to 64, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for SOWS', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; patient population at day 1 (n=650) is lower than overall safety population (n=665) due to missing data'}, {'type': 'SECONDARY', 'title': 'Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '665', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Population', 'description': 'Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.'}], 'classes': [{'title': 'Day 1 (n=646)', 'categories': [{'measurements': [{'value': '-52.8', 'groupId': 'OG000', 'lowerLimit': '-55.0', 'upperLimit': '-50.6'}]}]}, {'title': 'Week 4 (n=563)', 'categories': [{'measurements': [{'value': '-56.6', 'groupId': 'OG000', 'lowerLimit': '-59.0', 'upperLimit': '-54.2'}]}]}, {'title': 'Week 8 (n=479)', 'categories': [{'measurements': [{'value': '-59.4', 'groupId': 'OG000', 'lowerLimit': '-62.0', 'upperLimit': '-56.9'}]}]}, {'title': 'Week 12 (n=426)', 'categories': [{'measurements': [{'value': '-59.4', 'groupId': 'OG000', 'lowerLimit': '-62.0', 'upperLimit': '-56.8'}]}]}, {'title': 'Week 16 (n=384)', 'categories': [{'measurements': [{'value': '-61.5', 'groupId': 'OG000', 'lowerLimit': '-64.1', 'upperLimit': '-58.8'}]}]}, {'title': 'Week 20 (n=338)', 'categories': [{'measurements': [{'value': '-61.4', 'groupId': 'OG000', 'lowerLimit': '-64.3', 'upperLimit': '-58.5'}]}]}, {'title': 'Week 24 (n=289)', 'categories': [{'measurements': [{'value': '-60.5', 'groupId': 'OG000', 'lowerLimit': '-63.8', 'upperLimit': '-57.2'}]}]}, {'title': 'Study Endpoint (n=598)', 'categories': [{'measurements': [{'value': '-57.3', 'groupId': 'OG000', 'lowerLimit': '-59.6', 'upperLimit': '-55.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Prior to dosing on day 1, at weeks 4, 8, 12, 16, 20, and 24, and at study endpoint', 'description': 'Mean change from primary study baseline in VAS craving scores during the 24-week open-label, extension study; VAS craving scores range from 0 ("no cravings") to 100 mm ("most intense craving I have ever had"); study endpoint was defined as the last post-baseline value recorded for VAS craving', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; patient population at day 1 (n=646) is lower than overall safety population (n=665) due to missing data'}, {'type': 'SECONDARY', 'title': 'Percent Change From Primary Study Baseline (OX219-006 or OX219-007) for Question 1 of the Work Productivity/Activity Impairment: 6-Question Specific Health Problem Questionnaire (WPAI:SHP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '665', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Population', 'description': 'Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.'}], 'classes': [{'title': 'Unemployed at baseline; employed at study endpoint', 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000'}]}]}, {'title': 'Employed at baseline; unemployed at study endpoint', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000'}]}]}, {'title': 'Increase in patients employed at study endpoint', 'categories': [{'measurements': [{'value': '15.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Study Endpoint', 'description': 'Question 1 of the WPAI:SHP asks patients to provide a "yes" or "no" response to the question "Are you employed?"; The percentage of patients employed at the end of the 24-week open-label, extension study was calculated by subtracting the percentage of previously employed patients not employed at study end from the percentage of previously unemployed patients who were employed by study end', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; patients with missing data were excluded from the analysis and are reflected in the number of patients analyzed'}, {'type': 'SECONDARY', 'title': 'Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 2-4 of the WPAI:SHP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '665', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Population', 'description': 'Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.'}], 'classes': [{'title': 'Missed work hours due to opioid dependence (n=79)', 'categories': [{'measurements': [{'value': '-4.8', 'groupId': 'OG000', 'lowerLimit': '-8.1', 'upperLimit': '-1.5'}]}]}, {'title': 'Missed work hours due to other reason (n=79)', 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000', 'lowerLimit': '-1.9', 'upperLimit': '1.5'}]}]}, {'title': 'Number of hours actually worked (n=78)', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '12.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'Mean change from primary study baseline to week 24 of the open-label, extension study for questions 2-4 of the WPAI:SHP; Question 2: During the past 7 days, how many hours did you miss from work because of problems associated with your opioid dependence?; Question 3: During the past 7 days, how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study?; Question 4: During the past 7 days, how many hours did you actually work?', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed'}, {'type': 'SECONDARY', 'title': 'Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 5-6 of the WPAI:SHP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '665', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Population', 'description': 'Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.'}], 'classes': [{'title': 'Problem affects work productivity (n=70)', 'categories': [{'measurements': [{'value': '-3.9', 'groupId': 'OG000', 'lowerLimit': '-4.7', 'upperLimit': '-3.1'}]}]}, {'title': 'Problem affects daily activities (n=283)', 'categories': [{'measurements': [{'value': '-4.3', 'groupId': 'OG000', 'lowerLimit': '-4.8', 'upperLimit': '-3.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24', 'description': 'Mean change from primary study baseline to week 24 of the open-label extension study for questions 5-6 of the WPAI:SHP; Question 5: During the past 7 days, how much did your opioid dependence affect your productivity while you were working?; Question 6: During the past 7 days, how much did your opioid dependence affect your ability to do regular daily activities, other than work at a job?; Questions 5 and 6 of the WPAI:SHP are scored on an 11-point scale (0 = problem had no effect; 10 = problem completely prevented me from doing my work/daily activities)', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; patients with missing data were excluded from the analysis and are reflected in the number of participants analyzed'}, {'type': 'PRIMARY', 'title': 'Number of Patients Reporting Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '665', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Population', 'description': 'Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.'}], 'classes': [{'title': 'Constipation', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through week 24', 'description': 'Number of patients reporting treatment-emergent adverse events during open-label, extension treatment with higher bioavailability BNX sublingual tablets', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'PRIMARY', 'title': 'Number of Patients Reporting Treatment-Related, Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '665', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Population', 'description': 'Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.'}], 'classes': [{'title': 'Gastrointestinal disorders', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Constipation', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through week 24', 'description': 'Treatment-emergent adverse events considered related to treatment with the higher bioavailability BNX sublingual tablets', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'PRIMARY', 'title': 'Number of Patients Reporting Treatment-Emergent Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '665', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Population', 'description': 'Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.'}], 'classes': [{'title': 'Possibly treatment-related', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Not treatment-related', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 throught week 24', 'description': 'Patients reporting treatment-emergent serious adverse events considered either related or not related to treatment with the higher bioavailability BNX sublingual tablets', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'PRIMARY', 'title': 'Number of Patient Discontinuations Due to Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '665', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Safety Population', 'description': 'Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 through week 24', 'description': 'Study discontinuations due to treatment-emergent adverse events that occurred during treatment with bioavailability BNX sublingual tablets', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Safety Population', 'description': 'Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Primary study OX219-006 (n=475); Primary study OX219-007 (n=190)', 'groupId': 'FG000', 'numSubjects': '665'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Primary study OX219-006 (n=194); Primary study OX219-007 (n=98)', 'groupId': 'FG000', 'numSubjects': '292'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '373'}]}]}], 'preAssignmentDetails': 'A total of 668 patients who completed primary study OX219-006 (NCT01908842) or OX219-007 (NCT01848054) were enrolled. Three patients entered the study without taking any study medication and were excluded. A total of 665 patients were included in the data analyses.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '475', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '665', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'OX219-006 Completers', 'description': 'Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg and 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.'}, {'id': 'BG001', 'title': 'OX219-007 Completers', 'description': 'Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg and 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.9', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '39.0', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '36.8', 'spread': '11.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '196', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '259', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '279', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '406', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '410', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '583', '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': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '62', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '402', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '569', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '171.99', 'spread': '9.43', 'groupId': 'BG000'}, {'value': '173.35', 'spread': '10.01', 'groupId': 'BG001'}, {'value': '172.38', 'spread': '9.61', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '78.34', 'spread': '18.99', 'groupId': 'BG000'}, {'value': '78.98', 'spread': '20.73', 'groupId': 'BG001'}, {'value': '78.53', 'spread': '19.49', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '26.47', 'spread': '6.11', 'groupId': 'BG000'}, {'value': '26.26', 'spread': '6.63', 'groupId': 'BG001'}, {'value': '26.41', 'spread': '6.26', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Opioid Use', 'classes': [{'categories': [{'measurements': [{'value': '7.20', 'spread': '9.50', 'groupId': 'BG000'}, {'value': '9.6', 'spread': '8.79', 'groupId': 'BG001'}, {'value': '7.95', 'spread': '9.32', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Safety population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 668}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-28', 'studyFirstSubmitDate': '2013-07-09', 'resultsFirstSubmitDate': '2015-08-17', 'studyFirstSubmitQcDate': '2013-07-16', 'lastUpdatePostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-28', 'studyFirstPostDateStruct': {'date': '2013-07-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients Reporting Treatment-Emergent Adverse Events', 'timeFrame': 'Day 1 through week 24', 'description': 'Number of patients reporting treatment-emergent adverse events during open-label, extension treatment with higher bioavailability BNX sublingual tablets'}, {'measure': 'Number of Patients Reporting Treatment-Related, Treatment-Emergent Adverse Events', 'timeFrame': 'Day 1 through week 24', 'description': 'Treatment-emergent adverse events considered related to treatment with the higher bioavailability BNX sublingual tablets'}, {'measure': 'Number of Patients Reporting Treatment-Emergent Serious Adverse Events', 'timeFrame': 'Day 1 throught week 24', 'description': 'Patients reporting treatment-emergent serious adverse events considered either related or not related to treatment with the higher bioavailability BNX sublingual tablets'}, {'measure': 'Number of Patient Discontinuations Due to Treatment-Emergent Adverse Events', 'timeFrame': 'Day 1 through week 24', 'description': 'Study discontinuations due to treatment-emergent adverse events that occurred during treatment with bioavailability BNX sublingual tablets'}], 'secondaryOutcomes': [{'measure': 'Retention in Treatment in the Safety Population', 'timeFrame': 'Treatment retention was assessed at weeks 4, 8, 12, 16, 20, and 24', 'description': 'Retention in treatment by visit in the safety population at weeks 4, 8, 12, 16, 20, and 24, defined as the number of patients receiving treatment on the day of the visit (± 5 days for each visit)'}, {'measure': 'Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Clinical Opioid Withdrawal Scale (COWS) Score', 'timeFrame': 'Prior to dosing on day 1, at weeks 4, 8,12,16, 20, 24, and at study endpoint', 'description': 'Mean change from primary study baseline in COWS total scores during the 24-week open-label, extension study; COWS scores range from 0 to 48, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for COWS'}, {'measure': 'Mean Change From Primary Study Baseline (OX219-006 or OX219-007) in Subjective Opioid Withdrawal Scale (SOWS) Score', 'timeFrame': 'Prior to dosing on day 1, at weeks 4, 8,12,16, 20, and 24, and at study endpoint', 'description': 'Mean change from primary study baseline in SOWS total scores during the 24-week open-label, extension study; SOWS scores range from 0 to 64, with a lower score being more favorable; study endpoint was defined as the last post-baseline value recorded for SOWS'}, {'measure': 'Mean Change From Primary Study Baseline (OX219-006 and OX219-007) in Visual Analog Scale (VAS) Craving Scores', 'timeFrame': 'Prior to dosing on day 1, at weeks 4, 8, 12, 16, 20, and 24, and at study endpoint', 'description': 'Mean change from primary study baseline in VAS craving scores during the 24-week open-label, extension study; VAS craving scores range from 0 ("no cravings") to 100 mm ("most intense craving I have ever had"); study endpoint was defined as the last post-baseline value recorded for VAS craving'}, {'measure': 'Percent Change From Primary Study Baseline (OX219-006 or OX219-007) for Question 1 of the Work Productivity/Activity Impairment: 6-Question Specific Health Problem Questionnaire (WPAI:SHP)', 'timeFrame': 'Study Endpoint', 'description': 'Question 1 of the WPAI:SHP asks patients to provide a "yes" or "no" response to the question "Are you employed?"; The percentage of patients employed at the end of the 24-week open-label, extension study was calculated by subtracting the percentage of previously employed patients not employed at study end from the percentage of previously unemployed patients who were employed by study end'}, {'measure': 'Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 2-4 of the WPAI:SHP', 'timeFrame': 'Week 24', 'description': 'Mean change from primary study baseline to week 24 of the open-label, extension study for questions 2-4 of the WPAI:SHP; Question 2: During the past 7 days, how many hours did you miss from work because of problems associated with your opioid dependence?; Question 3: During the past 7 days, how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study?; Question 4: During the past 7 days, how many hours did you actually work?'}, {'measure': 'Mean Change From Primary Study Baseline (OX219-006 or OX219-007) for Questions 5-6 of the WPAI:SHP', 'timeFrame': 'Week 24', 'description': 'Mean change from primary study baseline to week 24 of the open-label extension study for questions 5-6 of the WPAI:SHP; Question 5: During the past 7 days, how much did your opioid dependence affect your productivity while you were working?; Question 6: During the past 7 days, how much did your opioid dependence affect your ability to do regular daily activities, other than work at a job?; Questions 5 and 6 of the WPAI:SHP are scored on an 11-point scale (0 = problem had no effect; 10 = problem completely prevented me from doing my work/daily activities)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Opioid, Dependence, agonist, Buprenorphine, Naloxone'], 'conditions': ['Opioid Dependence, on Agonist Therapy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to assess safety, efficacy, and treatment retention following extended treatment with OX219, a higher-bioavailability buprenorphine/naloxone (BNX) sublingual tablet formulation in opioid-dependent patients who completed 1 of 2 primary efficacy and safety studies of OX219.', 'detailedDescription': 'This was a multicenter, open-label, uncontrolled, single-arm, 24-week, extension study to assess safety, efficacy, and treatment retention during maintenance treatment.\n\nEligible patients had completed 1 of 2 primary efficacy and safety studies of the higher-bioavailability BNX sublingual tablet formulation (primary study OX219-006 \\[NCT01908842\\] or OX219-007 \\[NCT01848054\\]). The total duration of study treatment was 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Signed informed consent form.\n* Completion of 1 of 2 primary efficacy safety studies of BNX sublingual tablets (OX219-006 or OX219-007).\n* Female patients of child bearing potential who used a reliable method of contraception (hormonal, condom with spermicide, intrauterine device) during the previous OX219-006 or OX219-007 study and continue to use it for the OX219-008 study. Females who are not of child-bearing potential who are either surgically sterile (by hysterectomy, bilateral oophorectomy, bilateral salpingectomy, or tubal ligation), or postmenopausal, as defined by being at least 50 years of age and having had an absence of menses for at least 2 years, were also eligible.\n\nExclusion criteria\n\n* Females who are pregnant (positive pregnancy test result) or lactating, or planning to become pregnant during the study.\n* Participants who are unwilling or unable to comply with the requirements of the protocol (eg, pending incarceration) or are in a situation or condition that, in the opinion of the investigator, may interfere with participation in the study.\n* Participants who are participating in any other clinical study in which medication(s) are being delivered or who had used an investigational drug or device within the last 30 days.\n* Participants with any known allergy or sensitivity or intolerance to buprenorphine, naloxone, or any related drug, or history of any drug hypersensitivity or intolerance that, in the opinion of the investigator, would compromise the safety of the subject or the study.\n* Participant with a contra-indicated serious medical condition.\n* Participants who are at suicidal risk as determined by any of the following: a history of suicidal ideation ≤ 3 months prior to baseline with a score of 4 (intent to act) or 5 (specified plan and intent) on the Columbia Suicide Severity Risk Scale (C-SSRS).'}, 'identificationModule': {'nctId': 'NCT01903005', 'briefTitle': 'Multi-Center, Open-Label, 24-Week Study of OX219 Safety and Efficacy for Maintenance Treatment of Opioid Dependence', 'organization': {'class': 'INDUSTRY', 'fullName': 'Orexo AB'}, 'officialTitle': 'A Multi-center, Open-Label, 24-Week, Follow-Up Study to Assess Safety, Efficacy, and Treatment Adherence For Maintenance Treatment of Opioid Dependence With OX219', 'orgStudyIdInfo': {'id': 'OX219-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open-label BNX sublingual tablets', 'description': 'Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.', 'interventionNames': ['Drug: Higher bioavailability BNX sublingual tablets']}], 'interventions': [{'name': 'Higher bioavailability BNX sublingual tablets', 'type': 'DRUG', 'otherNames': ['OX219', 'Zubsolv', 'Buprenorphine/naloxone sublingual tablets'], 'description': 'Once daily, open-label treatment with higher bioavailability BNX sublingual tablets for 24 weeks', 'armGroupLabels': ['Open-label BNX sublingual tablets']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jefferson County', 'state': 'Alabama', 'country': 'United States'}, {'city': 'Marion County', 'state': 'Alabama', 'country': 'United States'}, {'city': 'Winston County', 'state': 'Alabama', 'country': 'United States'}, {'city': 'Maricopa County', 'state': 'Arizona', 'country': 'United States'}, {'city': 'Los Angeles County', 'state': 'California', 'country': 'United States'}, {'city': 'San Diego County', 'state': 'California', 'country': 'United States'}, {'city': 'Broward County', 'state': 'Florida', 'country': 'United States'}, {'city': 'Columbia County', 'state': 'Florida', 'country': 'United States'}, {'city': 'Duval County', 'state': 'Florida', 'country': 'United States'}, {'city': 'Jacksonville Metropolitan Area', 'state': 'Florida', 'country': 'United States'}, {'city': 'Miami-Dade County', 'state': 'Florida', 'country': 'United States'}, {'city': 'Orlando Metropolitan Area', 'state': 'Florida', 'country': 'United States'}, {'city': 'Osceola County', 'state': 'Florida', 'country': 'United States'}, {'city': 'Palm Beach County', 'state': 'Florida', 'country': 'United States'}, {'city': 'DeKalb County', 'state': 'Georgia', 'country': 'United States'}, {'city': 'Chicago Metropolitan Area', 'state': 'Illinois', 'country': 'United States'}, {'city': 'Baltimore County', 'state': 'Maryland', 'country': 'United States'}, {'city': 'Bristol County', 'state': 'Massachusetts', 'country': 'United States'}, {'city': 'Rankin County', 'state': 'Mississippi', 'country': 'United States'}, {'city': 'Saint Louis Metropolitan Area', 'state': 'Missouri', 'country': 'United States'}, {'city': 'Warren County', 'state': 'New Jersey', 'country': 'United States'}, {'city': 'Oklahoma County', 'state': 'Oklahoma', 'country': 'United States'}, {'city': 'Portland Metropolitan Area', 'state': 'Oregon', 'country': 'United States'}, {'city': 'Delaware County', 'state': 'Pennsylvania', 'country': 'United States'}, {'city': 'Philadelphia County', 'state': 'Pennsylvania', 'country': 'United States'}, {'city': 'Charleston County', 'state': 'South Carolina', 'country': 'United States'}, {'city': 'Salt Lake County', 'state': 'Utah', 'country': 'United States'}, {'city': 'Benton County', 'state': 'Washington', 'country': 'United States'}], 'overallOfficials': [{'name': 'Kent Hoffman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TRY Research, 406 Lake Howell Road, Maitland, Florida 32751'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orexo AB', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Worldwide Clinical Trials', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}