Buprenorphine for Probationers and Parolees: Bridging the Gap Into Treatment

• Status: Active, not recruiting
• Trial end date: 2023-04-30
• Target enrollment: 0
• Participant gender: All

Summary

This five-year study will evaluate the effectiveness of the administration of buprenorphine bridge treatment (BBT) to probationers and parolees compared to treatment as usual (TAU), which consists of referral to a community buprenorphine treatment program.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Friends Research Institute, Inc.
• Treatments: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone

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.