An Observational Study of Environmental and SocioEconomic Factors in Opioid Recovery

Study Overview
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Brief Summary
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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). The RECOVER study will characterize OUD subjects' recovery process as they transition from the controlled clinical trial environment to the real world setting.

Official Title
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Remission From Chronic Opioid Use: Studying Environmental and SocioEconomic Factors on Recovery-The RECOVER Study®

Conditions
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Opioid-use Disorder, Opioid-related Disorders

Intervention / Treatment
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* Other: Not applicable - no defined intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Ability to comply with study protocol requirements for data collection and provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Not applicable - no defined intervention|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Previous 28 Days at Month 24 | Based on self-reported abstinence from opioids using the National Survey on Drug Use and Health (NSDUH). | Month 24 | 
| 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 | Based on self-reported abstinence from opioids using the National Survey on Drug Use and Health (NSDUH). | Baseline (Day 1), Months 3, 6, 9, 12, 15, 18, 21, 24 | 
| 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 | Based on self-reported abstinence from opioids using the National Survey on Drug Use and Health (NSDUH). | Baseline (Day 1), Months 3, 6, 9, 12, 15, 18, 21, 24 | 
| Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Confirmed by Urine Drug Screen (UDS) at Month 24 | Based on self-reported abstinence from opioids (using NSDUH), and confirmed by UDS. | Month 24 | 
| 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 | Based on self-reported abstinence from opioids (using NSDUH), and confirmed by UDS. | Baseline (Day 1), Months 3, 6, 9, 12, 15, 18, 21, 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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