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.
Study Type
OBSERVATIONAL
Enrollment
534
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.
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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Day 1), Months 3, 6, 9, 12, 15, 18, 21, 24
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