Remission From Chronic Opioid Use: Studying Environmental and SocioEconomic Factors on Recovery-The RECOVER Study®
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Opioid-use Disorder
- Sponsor
- Indivior Inc.
- Enrollment
- 534
- Locations
- 35
- Primary Endpoint
- Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Previous 28 Days at Month 24
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Previous 28 Days at Month 24
Time Frame: Month 24
Based on self-reported abstinence from opioids using the National Survey on Drug Use and Health (NSDUH).
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
Time Frame: Baseline (Day 1), 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).
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
Time Frame: Baseline (Day 1), 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).
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
Time Frame: Baseline (Day 1), Months 3, 6, 9, 12, 15, 18, 21, 24
Based on self-reported abstinence from opioids (using NSDUH), and confirmed by UDS.
Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Confirmed by Urine Drug Screen (UDS) at Month 24
Time Frame: Month 24
Based on self-reported abstinence from opioids (using NSDUH), and confirmed by UDS.