Opioid-related Disorders, Opioid-use Disorder
Conditions
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
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.
Interventions
OTHERNot 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.
Sponsors
Indivior Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Previous 28 Days at Month 24 | 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 7 Days At Months 3, 6, 9, 12, 15, 18, 21, 24 | 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 28 Days At Months 3, 6, 9, 12, 15, 18, 21, 24 | 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). |
| Percentage of Participants Who Reported Abstinent From Opioids For the Previous 7 Days and Confirmed by Urine Drug Screen (UDS) at Month 24 | Month 24 | Based on self-reported abstinence from opioids (using NSDUH), and confirmed by UDS. |
| 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Amount of Health Care Resource Utilization (HCRU) at Months 1-12 and Months 13-24 | Months 1-12 and Months 13-24 | HCRU information includes hospitalizations, residential substance abuse treatment, general practitioner/specialist/and counseling visits, and emergency department (ED) visits. |
| Change from Baseline in 12-Item Short Form Health Survey, Version 2 (SF-12v2) to Months 12 and 24 | Baseline (Day 1), Months 12 and 24 | — |
| Number of Crimes Committed at Baseline, Months 1-12 and Months 13-24 | Baseline (Months -6 to Day 1), Months 1-12 and Months 13-24 | 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. |
| Change from Baseline in the Subjective Opioid Withdrawal Scale (SOWS) to Months 12 and 24 | Baseline (Day 1), Months 12 and 24 | — |
| Change from Baseline in the Beck Depression Inventory (BDI) to Months 12 and 24 | Baseline (Day 1), Months 12 and 24 | — |
| Change from Baseline in the Brief Pain Inventory (BPI) to Months 12 and 24 | Baseline (Day 1), Months 12 and 24 | — |
| Percentage of Participants Currently Employed at Baseline, Month 12 and Month 24 | Baseline (Day 1), Months 12 and 24 | — |
Countries
United States
Outcome results
None listed