Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2026-01-10 @ 6:45 AM
Study NCT ID:
NCT03275350
Status:
COMPLETED
Last Update Posted:
2022-04-27
First Post:
2017-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up
Sponsor:
Organization:
Raw JSON
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'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'korthuis@ohsu.edu', 'phone': '503-494-8044', 'title': 'Dr. Todd Korthuis', 'organization': 'Oregon Health & Science University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Extended-release Naltrexone (XR-NTX)', 'description': 'Extended-release naltrexone\n\nNaltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 11, 'seriousNumAtRisk': 55, 'deathsNumAffected': 2, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Treatment as Usual (TAU)', 'description': 'Treatment as usual\n\nTreatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 7, 'seriousNumAtRisk': 59, 'deathsNumAffected': 1, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervous system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury, poisoning and procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neoplasms benign, malignant and unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Naltrexone (XR-NTX)', 'description': 'Extended-release naltrexone\n\nNaltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU)', 'description': 'Treatment as usual\n\nTreatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic'}], 'classes': [{'title': '12 Weeks', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': '24 Weeks', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks and 24 weeks', 'description': 'HIV-1 RNA \\<200 copies/ml', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Non-inferiority analyses of HIV viral suppression by treatment arm Intent to Treat Group Missing imputed as unsuppressed'}, {'type': 'PRIMARY', 'title': 'Number of Participants With HIV Viral Suppression, Complete Case', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Naltrexone (XR-NTX)', 'description': 'Extended-release naltrexone\n\nNaltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU)', 'description': 'Treatment as usual\n\nTreatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic'}], 'classes': [{'title': '12 Weeks', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': '24 Weeks', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks and 24 weeks', 'description': 'HIV-1 RNA \\<200 copies/ml', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Non-inferiority analyses of HIV viral suppression by treatment arm Complete case: Includes 81 participants with non-missing viral load data at 12 and 24 weeks'}, {'type': 'PRIMARY', 'title': 'Number of Participants With HIV Viral Suppression, Per-protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Naltrexone (XR-NTX)', 'description': 'Extended-release naltrexone\n\nNaltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU)', 'description': 'Treatment as usual\n\nTreatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic'}], 'classes': [{'title': '12 weeks', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks and 24 weeks', 'description': 'HIV-1 RNA \\<200 copies/ml', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Non-inferiority analyses of HIV viral suppression by treatment arm Missing as unsuppressed Per-protocol population includes 69 participants who received at least one dose of their assigned study medication.'}, {'type': 'SECONDARY', 'title': 'Veterans Aging Cohort Study (VACS) Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Naltrexone (XR-NTX)', 'description': 'Extended-release naltrexone\n\nNaltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU)', 'description': 'Treatment as usual\n\nTreatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '65.1', 'spread': '18.1', 'groupId': 'OG000'}, {'value': '68.4', 'spread': '24.7', 'groupId': 'OG001'}]}]}, {'title': '24 Weeks', 'categories': [{'measurements': [{'value': '54.4', 'spread': '20.7', 'groupId': 'OG000'}, {'value': '63.5', 'spread': '25.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Absolute value of participant VACS Index at baseline and 24 weeks\n\nVeterans Aging Cohort Study Index Minimum value: 0 Maximum value: 164 A higher score means a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CD4 Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Naltrexone (XR-NTX)', 'description': 'Extended-release naltrexone\n\nNaltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU)', 'description': 'Treatment as usual\n\nTreatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '380.7', 'spread': '248.2', 'groupId': 'OG000'}, {'value': '439.8', 'spread': '336.6', 'groupId': 'OG001'}]}]}, {'title': '24 Weeks', 'categories': [{'measurements': [{'value': '459.1', 'spread': '249.1', 'groupId': 'OG000'}, {'value': '505.1', 'spread': '349.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Cluster of Differentiation 4\n\nAbsolute value of CD4 count at baseline and 24 weeks.', 'unitOfMeasure': 'cells/mm3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Engagement in HIV Care: Antiretroviral Therapy Prescribed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Naltrexone (XR-NTX)', 'description': 'Extended-release naltrexone\n\nNaltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU)', 'description': 'Treatment as usual\n\nTreatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': '24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Absolute value of participants prescribed ART at baseline and within 24 weeks following randomization. Each individual can be scored 0 (not prescribed ART) or 1 (prescribed ART) at both baseline and follow-up, after which his or her outcome score will be the follow-up score minus the baseline score. Outcomes will be analyzed via rank-based methods such as Wilcoxon rank-sum tests.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed at 24 weeks lower than baseline due to study retention and availability of data.'}, {'type': 'SECONDARY', 'title': 'Engagement in HIV Care: 100% Antiretroviral Therapy Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Naltrexone (XR-NTX)', 'description': 'Extended-release naltrexone\n\nNaltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone.'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU)', 'description': 'Treatment as usual\n\nTreatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 weeks', 'description': 'Number of participants taking 100% of prescribed ART doses in the past month at 24 weeks for those prescribed ART at any point during the 24 week trial (proportion; self-reported medication adherence measure). Chi-squared test comparing proportion to treatment assignment, for those prescribed ART.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure is based on participant self-report. As such, fewer participants provided data for this outcome measure than other measures where data was obtained through pharmacy or clinic attendance logs.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least 1 HIV Care Visit in Past 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Naltrexone (XR-NTX)', 'description': 'Extended-release naltrexone\n\nNaltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU)', 'description': 'Treatment as usual\n\nTreatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 weeks', 'description': 'At least 1 HIV care visit in past 12 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure is based on participant self-report. As such, fewer participants provided data for this outcome measure than other measures where data was obtained through pharmacy or clinic attendance logs.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Had Unprotected Sex in Past 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Naltrexone (XR-NTX)', 'description': 'Extended-release naltrexone\n\nNaltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU)', 'description': 'Treatment as usual\n\nTreatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': '24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Past 30 day unprotected sex, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Those reporting no sex are excluded.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Multiple Sex Partners in Past 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Naltrexone (XR-NTX)', 'description': 'Extended-release naltrexone\n\nNaltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU)', 'description': 'Treatment as usual\n\nTreatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': '24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Past 30 day multiple sex partners, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Two or more sex partners during past month, those reporting no sex partners are excluded'}, {'type': 'SECONDARY', 'title': 'Engagement in HIV Care: Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Naltrexone (XR-NTX)', 'description': 'Extended-release naltrexone\n\nNaltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU)', 'description': 'Treatment as usual\n\nTreatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '58', 'spread': '19.1', 'groupId': 'OG000'}, {'value': '64.3', 'spread': '17.6', 'groupId': 'OG001'}]}]}, {'title': '24 Weeks', 'categories': [{'measurements': [{'value': '67.9', 'spread': '21.2', 'groupId': 'OG000'}, {'value': '71.2', 'spread': '19.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Past 30 day health-related quality of life as measured by the EQ-5D questionnaire at baseline and week 24.\n\nMinimum value: 0 Maximum value: 100 Higher scores mean a better outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Number of Self-Reported Days of Opioid Use in Last 30 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Naltrexone (XR-NTX)', 'description': 'Extended-release naltrexone\n\nNaltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU)', 'description': 'Treatment as usual\n\nTreatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic'}], 'classes': [{'title': 'Intent-to-treat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.73', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30'}, {'value': '14.81', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '30'}]}]}, {'title': 'Per-protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.02', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '30'}, {'value': '13.58', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '30'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Between baseline and 24 weeks', 'description': 'Average number of days of opioid use between baseline and 24 weeks, measured by the Timeline Follow-Back (count; self-report), will be used to compare opioid use by treatment group. Confirmatory analysis will assess opioid use by the average number of days of opioid use in the last 30 days of the study (by Addiction Severity Index-lite; count; self-report) and the number of monthly urine drug screen (UDS) negative for opioids between baseline and 24 weeks (count; laboratory data).', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population includes participants who received at least one dose of their assigned study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Test Positive for Opioids at 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended-release Naltrexone (XR-NTX)', 'description': 'Extended-release naltrexone\n\nNaltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone'}, {'id': 'OG001', 'title': 'Treatment as Usual (TAU)', 'description': 'Treatment as usual\n\nTreatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic'}], 'classes': [{'title': 'Intent-to-treat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Per-protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 weeks', 'description': 'Number and percent of participants with UDS positive for opioids at 24 weeks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population includes participants who received at least one dose of their assigned study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Extended-release Naltrexone (XR-NTX)', 'description': 'Extended-release naltrexone\n\nNaltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone'}, {'id': 'FG001', 'title': 'Treatment as Usual (TAU)', 'description': 'Treatment as usual\n\nTreatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Incarcerated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Extended-release Naltrexone (XR-NTX)', 'description': 'Extended-release naltrexone\n\nNaltrexone Injectable Suspension: Six monthly injections of extended-release naltrexone'}, {'id': 'BG001', 'title': 'Treatment as Usual (TAU)', 'description': 'Treatment as usual\n\nTreatment as usual: Standard treatment for opioid use disorder provided at each HIV clinic'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '46', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '47', 'spread': '11.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '100', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '30', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HIV Viral Load', 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '4.0', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '4.0', 'spread': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-30', 'size': 1755048, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-04-13T12:08', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-26', 'studyFirstSubmitDate': '2017-08-28', 'resultsFirstSubmitDate': '2021-04-28', 'studyFirstSubmitQcDate': '2017-09-05', 'lastUpdatePostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-26', 'studyFirstPostDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With HIV Viral Suppression, Missing Imputed as Unsuppressed', 'timeFrame': '12 weeks and 24 weeks', 'description': 'HIV-1 RNA \\<200 copies/ml'}, {'measure': 'Number of Participants With HIV Viral Suppression, Complete Case', 'timeFrame': '12 weeks and 24 weeks', 'description': 'HIV-1 RNA \\<200 copies/ml'}, {'measure': 'Number of Participants With HIV Viral Suppression, Per-protocol', 'timeFrame': '12 weeks and 24 weeks', 'description': 'HIV-1 RNA \\<200 copies/ml'}], 'secondaryOutcomes': [{'measure': 'Veterans Aging Cohort Study (VACS) Index', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Absolute value of participant VACS Index at baseline and 24 weeks\n\nVeterans Aging Cohort Study Index Minimum value: 0 Maximum value: 164 A higher score means a worse outcome.'}, {'measure': 'CD4 Count', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Cluster of Differentiation 4\n\nAbsolute value of CD4 count at baseline and 24 weeks.'}, {'measure': 'Engagement in HIV Care: Antiretroviral Therapy Prescribed', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Absolute value of participants prescribed ART at baseline and within 24 weeks following randomization. Each individual can be scored 0 (not prescribed ART) or 1 (prescribed ART) at both baseline and follow-up, after which his or her outcome score will be the follow-up score minus the baseline score. Outcomes will be analyzed via rank-based methods such as Wilcoxon rank-sum tests.'}, {'measure': 'Engagement in HIV Care: 100% Antiretroviral Therapy Adherence', 'timeFrame': '24 weeks', 'description': 'Number of participants taking 100% of prescribed ART doses in the past month at 24 weeks for those prescribed ART at any point during the 24 week trial (proportion; self-reported medication adherence measure). Chi-squared test comparing proportion to treatment assignment, for those prescribed ART.'}, {'measure': 'Number of Participants With at Least 1 HIV Care Visit in Past 12 Weeks', 'timeFrame': '24 weeks', 'description': 'At least 1 HIV care visit in past 12 weeks'}, {'measure': 'Number of Participants Who Had Unprotected Sex in Past 30 Days', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Past 30 day unprotected sex, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).'}, {'measure': 'Number of Participants With Multiple Sex Partners in Past 30 Days', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Past 30 day multiple sex partners, as measured by the Risk Assessment Battery at baseline and week 24 (binary; self-report).'}, {'measure': 'Engagement in HIV Care: Quality of Life', 'timeFrame': 'Baseline and 24 weeks', 'description': 'Past 30 day health-related quality of life as measured by the EQ-5D questionnaire at baseline and week 24.\n\nMinimum value: 0 Maximum value: 100 Higher scores mean a better outcome'}, {'measure': 'Average Number of Self-Reported Days of Opioid Use in Last 30 Days', 'timeFrame': 'Between baseline and 24 weeks', 'description': 'Average number of days of opioid use between baseline and 24 weeks, measured by the Timeline Follow-Back (count; self-report), will be used to compare opioid use by treatment group. Confirmatory analysis will assess opioid use by the average number of days of opioid use in the last 30 days of the study (by Addiction Severity Index-lite; count; self-report) and the number of monthly urine drug screen (UDS) negative for opioids between baseline and 24 weeks (count; laboratory data).'}, {'measure': 'Number of Participants Who Test Positive for Opioids at 24 Weeks', 'timeFrame': '24 weeks', 'description': 'Number and percent of participants with UDS positive for opioids at 24 weeks.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid-use Disorder', 'Hiv']}, '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': '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': '34758887', 'type': 'DERIVED', 'citation': 'Hoffman KA, Baker R, Fanucchi LC, Lum PJ, Kunkel LE, Ponce Terashima J, McCarty D, Jacobs P, Korthuis PT. Perspectives on extended-release naltrexone induction among patients living with HIV and opioid use disorder: a qualitative analysis. Addict Sci Clin Pract. 2021 Nov 10;16(1):67. doi: 10.1186/s13722-021-00277-z.'}]}, 'descriptionModule': {'briefSummary': 'The Primary Objective of this study is to compare the effectiveness of HIV clinic-based extended-release Naltrexone (XR-NTX) in decreasing substance use and increasing HIV viral suppression in HIV-infected participants with opioid use disorder to Treatment as Usual in this population.', 'detailedDescription': 'The CTN-0055 CHOICES pilot study demonstrated the feasibility of extended-release naltrexone (XR-NTX) for treatment of opioid use disorder in HIV primary care. The CTN-0067 CHOICES scale-up study builds on lessons learned from the pilot and uses the Consolidated Framework for Implementation Research to advance understanding of XR-NTX adoption in HIV primary care clinics. The study is an open-label, randomized, comparative effectiveness trial of office-based XR-NTX for 24 weeks (6 monthly injections) versus treatment as usual (TAU) in HIV-infected participants with untreated opioid use disorder. Each participant will be engaged in the overall study for 25 to 28 weeks, depending on the speed of screening and enrollment procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is at least 18 years old\n* Participant has provided written informed consent and HIPAA for medical record abstraction\n* Participant meets Diagnostic and Statistical (DSM)-5 criteria for moderate or severe opioid use disorder\n* Willing to be randomized to antagonist-based therapy or TAU for treatment of opioid use disorder\n* Has an HIV viral RNA count of greater than 200 copies/ml (not clinically suppressed)\n* Willing to establish ongoing HIV care at the site if not already receiving ongoing care\n* If female, willing to take at least one evidence-based measure to avoid becoming pregnant\n\nExclusion Criteria:\n\n* Participant has a serious medical, psychiatric, or substance use disorder that, in the opinion of the study physician, would make participation hazardous to the participant, compromise study findings, or prevent participant from completing the study. Examples include:\n* Acutely life-threatening medical illnesses (e.g., active opportunistic infection, uncompensated heart failure, end-stage liver disease, acute hepatitis and moderate to severe renal impairment) as assessed by medical history, review of symptoms, physical exam and/or laboratory assessments\n* Severe, inadequately treated mental health disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and/or clinical interview\n* Suicidal or homicidal ideation requiring immediate attention\n* Participant has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) liver enzymes greater than five times the upper limit of normal on screening phlebotomy\n* Participant has an international normalized ratio (INR) \\> 1.5 or platelet count \\<100k\n* Participant has a known allergy or sensitivity to naloxone, naltrexone, polyactide-co-glycolide, carboxymethylcellulose, or other components of the Vivitrol diluent\n* Anticipate undergoing surgery during study participation\n* Have chronic pain requiring ongoing pain management with opioid analgesics\n* If female, currently (at time of consent) pregnant or breastfeeding or planning on conceiving in the coming months\n* Body habitus that, in the judgment of the study physician, precludes safe intramuscular injection on XR-NTX (e.g., excess fat tissue over the buttocks)\n* Received methadone of buprenorphine maintenance therapy for treatment of opioid dependence in the 4 weeks prior to screening\n* Have taken an investigational drug in another study within 30 days of study consent\n* Have had treatment with XR-NTX for opioid or alcohol dependence in the 4 weeks prior to consent\n* Are currently in jail, prison or have a pending legal action which may prevent an individual from completing the study'}, 'identificationModule': {'nctId': 'NCT03275350', 'briefTitle': 'Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Comparing Treatments for HIV-Infected Opioid Users in an Integrated Care Effectiveness Study (CHOICES) Scale-Up', 'orgStudyIdInfo': {'id': 'Clinical Trials Network-0067'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'XR-NTX', 'description': 'Extended-release naltrexone', 'interventionNames': ['Drug: Naltrexone Injectable Suspension']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TAU', 'description': 'Treatment as usual', 'interventionNames': ['Other: Treatment as usual']}], 'interventions': [{'name': 'Naltrexone Injectable Suspension', 'type': 'DRUG', 'description': 'Six monthly injections of extended-release naltrexone', 'armGroupLabels': ['XR-NTX']}, {'name': 'Treatment as usual', 'type': 'OTHER', 'description': 'Standard treatment for opioid use disorder provided at each HIV clinic', 'armGroupLabels': ['TAU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91356', 'city': 'Tarzana', 'state': 'California', 'country': 'United States', 'facility': 'Tarzana Treatment Centers', 'geoPoint': {'lat': 34.17334, 'lon': -118.55397}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Jackson Memorial Hospital', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Ruth M. Rothstein CORE Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky Bluegrass Care Clinic', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University, Bartlett Specialty Clinic', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'University of Kentucky', 'class': 'OTHER'}, {'name': 'Jackson Health System', 'class': 'OTHER'}, {'name': 'Tarzana Treatment Centers', 'class': 'OTHER'}, {'name': 'Ruth M. Rothstein CORE Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'P. Todd Korthuis, MD', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}