Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2026-01-01 @ 11:13 PM
Study NCT ID:
NCT03604861
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2018-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study of Environmental and SocioEconomic Factors in Opioid Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D006556', 'term': 'Heroin Dependence'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}], 'ancestors': [{'id': 'D000079524', 'term': 'Narcotic-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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 534}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-17', 'studyFirstSubmitDate': '2018-07-09', 'studyFirstSubmitQcDate': '2018-07-19', 'lastUpdatePostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from Baseline in 12-Item Short Form Health Survey, Version 2 (SF-12v2) to Months 12 and 24', 'timeFrame': 'Baseline (Day 1), Months 12 and 24'}, {'measure': 'Change from Baseline in the Subjective Opioid Withdrawal Scale (SOWS) to Months 12 and 24', 'timeFrame': 'Baseline (Day 1), Months 12 and 24'}, {'measure': 'Change from Baseline in the Beck Depression Inventory (BDI) to Months 12 and 24', 'timeFrame': 'Baseline (Day 1), Months 12 and 24'}, {'measure': 'Change from Baseline in the Brief Pain Inventory (BPI) to Months 12 and 24', 'timeFrame': 'Baseline (Day 1), Months 12 and 24'}, {'measure': 'Percentage of Participants Currently Employed at Baseline, Month 12 and Month 24', 'timeFrame': 'Baseline (Day 1), Months 12 and 24'}, {'measure': 'Amount of Health Care Resource Utilization (HCRU) at Months 1-12 and Months 13-24', 'timeFrame': 'Months 1-12 and Months 13-24', 'description': 'HCRU information includes hospitalizations, residential substance abuse treatment, general practitioner/specialist/and counseling visits, and emergency department (ED) visits.'}, {'measure': 'Number of Crimes Committed at Baseline, Months 1-12 and Months 13-24', 'timeFrame': 'Baseline (Months -6 to Day 1), Months 1-12 and Months 13-24', 'description': "Participants complete surveys to identify the number and type of criminal incidents in a given time frame. These questions include information on arrests, violence, unlawful behaviors, and driver's license status."}], 'primaryOutcomes': [{'measure': 'Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Previous 28 Days at Month 24', 'timeFrame': 'Month 24', 'description': 'Based on self-reported abstinence from opioids using the National Survey on Drug Use and Health (NSDUH).'}, {'measure': 'Change from Baseline in Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days At Months 3, 6, 9, 12, 15, 18, 21, 24', 'timeFrame': 'Baseline (Day 1), Months 3, 6, 9, 12, 15, 18, 21, 24', 'description': 'Based on self-reported abstinence from opioids using the National Survey on Drug Use and Health (NSDUH).'}, {'measure': 'Change from Baseline in Percentage of Participants Who Reported Abstinent From Opioids For the Previous 28 Days At Months 3, 6, 9, 12, 15, 18, 21, 24', 'timeFrame': 'Baseline (Day 1), Months 3, 6, 9, 12, 15, 18, 21, 24', 'description': 'Based on self-reported abstinence from opioids using the National Survey on Drug Use and Health (NSDUH).'}, {'measure': 'Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Confirmed by Urine Drug Screen (UDS) at Month 24', 'timeFrame': 'Month 24', 'description': 'Based on self-reported abstinence from opioids (using NSDUH), and confirmed by UDS.'}, {'measure': 'Change from Baseline in Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Confirmed by UDS At Months 3, 6, 9, 12, 15, 18, 21, 24', 'timeFrame': 'Baseline (Day 1), Months 3, 6, 9, 12, 15, 18, 21, 24', 'description': 'Based on self-reported abstinence from opioids (using NSDUH), and confirmed by UDS.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Opioid recovery', 'Recovery', 'Opioid-related disorders', 'Substance-related disorders', 'Heroin dependence', 'Opioid dependence', 'Addiction', 'Buprenorphine', 'Opiate substitution treatment', 'Analgesics', 'Opioid', 'Narcotics', 'Patient outcome assessment', 'Patient-centered care', 'Cost of illness', 'Employment', 'Health-related quality-of-life', 'Family relations', 'Lifestyle', 'Citizenship'], 'conditions': ['Opioid-use Disorder', 'Opioid-related Disorders']}, 'referencesModule': {'references': [{'pmid': '35287034', 'type': 'DERIVED', 'citation': 'Craft WH, Tegge AN, Keith DR, Shin H, Williams J, Athamneh LN, Stein JS, Chilcoat HD, Le Moigne A, DeVeaugh-Geiss A, Bickel WK. Recovery from opioid use disorder: A 4-year post-clinical trial outcomes study. Drug Alcohol Depend. 2022 May 1;234:109389. doi: 10.1016/j.drugalcdep.2022.109389. Epub 2022 Mar 9.'}, {'pmid': '32187112', 'type': 'DERIVED', 'citation': 'Ling W, Nadipelli VR, Aldridge AP, Ronquest NA, Solem CT, Chilcoat H, Albright V, Johnson C, Learned SM, Mehra V, Heidbreder C. Recovery From Opioid Use Disorder (OUD) After Monthly Long-acting Buprenorphine Treatment: 12-Month Longitudinal Outcomes From RECOVER, an Observational Study. J Addict Med. 2020 Sep/Oct;14(5):e233-e240. doi: 10.1097/ADM.0000000000000647.'}]}, 'descriptionModule': {'briefSummary': "The RECOVER Study will examine clinical, environmental and socioeconomic factors in recovery from opioid use disorder (OUD) over a 24-month period following exit from a Phase III clinical program for a buprenorphine extended-release injection (RBP-6000). The study population will consist of participants from studies NCT02357901 (RB-US-13-0001) and NCT02510014 (RB-US-13-0003).\n\nThe RECOVER study will characterize OUD subjects' recovery process as they transition from the controlled clinical trial environment to the real world setting."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are currently diagnosed with moderate or severe OUD according to Diagnostic and Statistical Manual 5 (DSM-5) criteria and for 3 months immediately prior to signing the informed consent form for protocols NCT02357901 (RB-US-13-0001) and/or NCT02510014 (RB-US-13-0003).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who received at least one injection in RBP-6000 or placebo in the Phase III clinical program which includes study protocols NCT02357901 (RB-US-13-0001) and NCT02510014 (RB-US-13-0003) and either withdrew from or completed these studies.\n* Ability to comply with study protocol requirements for data collection and provide informed consent.'}, 'identificationModule': {'nctId': 'NCT03604861', 'acronym': 'RECOVER®', 'briefTitle': 'An Observational Study of Environmental and SocioEconomic Factors in Opioid Recovery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Indivior Inc.'}, 'officialTitle': 'Remission From Chronic Opioid Use: Studying Environmental and SocioEconomic Factors on Recovery-The RECOVER Study®', 'orgStudyIdInfo': {'id': 'INDV-6000-N01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Not applicable - no defined intervention', 'type': 'OTHER', 'description': 'Participants who received at least one injection of RBP-6000 or placebo and either withdrew from or completed the Phase III clinical program which included studies NCT02357901 (RB-US-13-0001) and NCT02510014 (RB-US-13-0003) were eligible for the RECOVER Study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35565', 'city': 'Haleyville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Winston Technology Research LLC', 'geoPoint': {'lat': 34.22649, 'lon': -87.62141}}, {'zip': '35570', 'city': 'Hamilton', 'state': 'Alabama', 'country': 'United States', 'facility': 'Boyett Health Services', 'geoPoint': {'lat': 34.14232, 'lon': -87.98864}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Woodland International Research Group', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Behavioral Research Specialists', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Networks, Inc.', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'National City', 'state': 'California', 'country': 'United States', 'facility': 'Synergy Research Center', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}, {'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'North County Clinical Research', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Artemis Institute for Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Amit Vijapura', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Lakeland', 'state': 'Florida', 'country': 'United States', 'facility': 'Meridien Research', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Try Research', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Innovative Clinical Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Scientific Clinical Research', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Oakland Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Centers of America', 'geoPoint': {'lat': 26.17231, 'lon': -80.13199}}, {'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana Research Associates', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana Clinical Research', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Stanley Street Treatment and Resources', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '02472', 'city': 'Watertown', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Adams Clinical Trials', 'geoPoint': {'lat': 42.37093, 'lon': -71.18283}}, {'city': 'Flowood', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Precise Research Centers, Inc.', 'geoPoint': {'lat': 32.30959, 'lon': -90.13898}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis Clinical Trials', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Altea Research Institute', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08009', 'city': 'Berlin', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hassman Research Institute', 'geoPoint': {'lat': 39.79123, 'lon': -74.92905}}, {'zip': '08002', 'city': 'Cherry Hill', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Center for Emotional Fitness', 'geoPoint': {'lat': 39.93484, 'lon': -75.03073}}, 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