Assessing Optimal XR-Buprenorphine Initiation Points in Jail

• Status: Not yet recruiting
• Trial end date: 2024-02-28
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study is to compare two approaches for commencing pharmacotherapy with injectable buprenorphine for opioid use disorder (OUD) among jail inmates: (1) at the time of admission or (2) shortly before release. A sample of eligible inmates with sentences of less than 180 days will be randomly assigned to (1) initiating extended-release buprenorphine (XR-B) treatment at the time of admission (n=80), or (2) initiating XR-B treatment within 30 prior to their scheduled release date (n=80). The groups will be compared with regard to (1) how likely they were to participate in treatment, (2) levels of in-jail opioid use (via post-release interviews), (3) continuation of pharmacotherapy and other OUD treatment in the community, and (4) levels of opioid use 4 and 12 weeks following discharge (self-report and incentivized voluntary urine tests).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NYU Langone Health
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Buprenorphine

Criteria

Inclusion Criteria:

1. Incarcerated adults able to provide written informed consent in English.

2. Currently sentenced with pending release date between 3-7 months.

3. Current moderate-to-severe opioid use disorder (DSM-5)

4. Reasonable likelihood of completing 3-months or longer of community treatment (i.e., no plans to be transferred out of state or to another correctional facility)

5. Willing to accept being randomized to initiating XR-B treatment at the time of jail admission or near the time of release.

Exclusion Criteria:

1. Severe medical or psychiatric disability making participation unsafe or regular follow-up unlikely, including patients with pre-existing moderate to severe hepatic impairment are not eligible to participate

2. Pregnancy, planning conception, or breast-feeding

3. Allergy, hypersensitivity or medical contraindication to either medication

4. Chronic pain requiring opioid pain management

5. On methadone or buprenorphine (SL-B) maintenance prior to incarceration AND intending to remain on methadone or buprenorphine maintenance upon return to the community.