Using buprenorphine to help probationers and parolees with opioid use disorder
Buprenorphine for Probationers and Parolees: Bridging the Gap Into Treatment
This study is testing if giving buprenorphine treatment right away to people on probation or parole with opioid use disorder helps them do better than the usual treatment options.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Friends Research Institute, Inc. Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT03616236 on ClinicalTrials.gov |
What this trial studies
This five-year study evaluates the effectiveness of buprenorphine bridge treatment (BBT) for probationers and parolees with opioid use disorder (OUD) compared to standard treatment as usual (TAU). Participants will be randomly assigned to receive either immediate buprenorphine treatment at a community supervision office or a referral to community treatment. The study will assess participants at multiple time points over the year to measure outcomes such as illicit opioid use. The goal is to determine if BBT leads to better outcomes than the usual referral process.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 on probation or parole with a primary diagnosis of moderate to severe opioid use disorder.
Not a fit: Patients who are currently experiencing psychosis, suicidal ideation, or have pending legal actions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment engagement and outcomes for individuals with opioid use disorder on probation or parole.
How similar studies have performed: Other studies have shown promise in using buprenorphine for treating opioid use disorder, but this specific approach targeting probationers and parolees is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subject must provide written informed consent prior to the conduct of any study-related procedures 2. Male or female, 18-65 years of age, inclusive 3. Be on parole or probation for at least the next 4 months 4. Have a Baltimore City address, and (5) Primary diagnosis of (DSM-5) moderate-severe opioid use disorder (at least 4 symptoms) including current use and current physiologic dependence \[Note: parolees not currently physically dependent will be allowed in the study\]. Exclusion Criteria: 1. Current medical condition that may prevent the participant from safely participating in the study as determined by medical evaluation 2. Current psychosis or suicidal ideation 3. Cognitive disorders that prevent the participant from passing a study enrollment quiz 4. Any pending legal action that would interrupt study participation (eg, pending incarceration, probation/parole revocation, unadjudicated charges) 5. Exposure to any investigational drug within 8 weeks of screening 6. Current use benzodiazepines (such as Valium, Xanax and other sedatives), either prescribed or illicitly obtained 7. Currently enrolled in a methadone maintenance treatment program or taking long-acting naltrexone.
Where this trial is running
Baltimore, Maryland
- Division of Parole & Probation — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Study coordinator: Michael S Gordon, DPA
- Email: mgordon@friendsresearch.org
- Phone: 410-837-3977
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.