Buprenorphine for Opioid Use Disorder

Phase 3

Waitlist Available

Research Sponsored by Friends Research Institute, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare two forms of buprenorphine treatment for adults with opioid use disorder who are about to be released from a large city jail. Participants will be randomly assigned to receive either extended

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Buprenorphine can cause side effects like nausea, drowsiness, constipation, headache, or sweating. Since it's used for OUD treatment, the focus is on managing withdrawal symptoms and reducing cravings.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

days of opioid use

time to opioid relapse

urine toxicology

Secondary study objectives

HIV risk behaviors (Risk Assessment Battery, RAB) - sex risk score

HIV risk behaviors (Risk Assessment Battery, RAB) needle use or sharing score

PROMIS Patient-Reported Outcomes Measurement Information System - mental health

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

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