Buprenorphine for Opioid Use Disorder

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Friends Research Institute, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This study is an open label randomized controlled trial of extended-release buprenorphine (BRIXADI, XR-B) vs. sublingual buprenorphine (SL-B) in a large metropolitan jail. An open-label design will randomly assign 240 adults with moderate-to-severe OUDs who are soon-to-be-released from jail to either XR-B (n=120) or SL-B (n=120) treatment in jail followed by 6-months of post-release buprenorphine treatment, a 7-month safety visit, and a final long-term follow-up at 12-months.

Eligibility Criteria

This trial is for adults in a large metropolitan jail with moderate-to-severe opioid use disorder (OUD) who are soon to be released. Participants will continue treatment after release and attend follow-up visits up to 12 months.

Inclusion Criteria

Individuals who are pre-trial and/or sentenced who are completing their sentence in the community

Willingness to enroll in XR-B or SL-B treatment in jail and continue in the community

I have a history of moderate to severe opioid use disorder or was in a treatment program before being incarcerated.

+3 more

Exclusion Criteria

Liver function test levels greater than 5 times normal

I was unable to pass the study's enrollment quiz.

Currently receiving non-buprenorphine MOUD in jail (methadone, naltrexone)

+5 more

Participant Groups

The study compares two forms of buprenorphine: extended-release (XR-B) versus sublingual (SL-B). It's an open-label trial, meaning everyone knows which treatment they're getting, with participants randomly assigned to either group.

2Treatment groups

Experimental Treatment

Active Control

Group I: extended-release buprenorphine (XR-B)Experimental Treatment1 Intervention

Participants will receive sublingual (sl; taken under the tongue) buprenorphine/naloxone doses of 2 mg for two days followed by 4mg for 2 days. The speed of induction will be based on their response to sl buprenorphine/naloxone. If they tolerate sl buprenorphine, on day 4 they will be administered an 8 mg dose of BRIXADI on day 5 (if they do not tolerate sl buprenorphine/naloxone we will extend sl dosing). During week two of dosing, they will receive 16 mg dose of BRIXADI will be given, based on the participant's response to the previous dose. During week three of dosing, they will receive a 24 mg dose of BRIXADI. During week four they will be administered a monthly dose of 64mg, 96mg, or 128mg. In all cases, the dose selected will be based on their response to the previous weeks' dose. We will endeavor to get you on the 96 mg or 128 mg monthly dose as there is a lack of opioid blockade data for the 64 mg monthly dose.

Group II: sublingual buprenorphine (SL-B)Active Control1 Intervention