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Opioid Agonist

Extended-release vs Sublingual Buprenorphine for Opioid Use Disorder (RXR Trial)

Phase 3

Waitlist Available

Led By Yih-Ing Hser, PhD

Research Sponsored by Yih-Ing Hser

Eligibility Criteria Checklist

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

Must have

Be ≥18 years of age

Meet DSM-5 criteria for moderate to severe OUD or be on buprenorphine medication for OUD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will explore how well an extended-release injectable medication helps people with opioid use disorder in rural areas. It will compare it to a standard medication. Results will include patient outcomes.

Who is the study for?

This trial is for adults over 18 with moderate to severe opioid use disorder (OUD) who live in rural areas. They must speak English, agree to birth control if applicable, and be willing to take either sublingual or injectable buprenorphine as treatment. People can't join if they've recently used methadone, have certain medical or psychiatric conditions, are pregnant/breastfeeding, or have legal issues that could interfere.

What is being tested?

The study compares two forms of buprenorphine: a monthly injectable extended-release version (XR-BUP) and a daily sublingual tablet (SL-BUP). Participants will be randomly assigned to one of these treatments for 14 weeks and monitored through assessments and interviews to determine which is more effective in rural settings.

What are the potential side effects?

Possible side effects include nausea, constipation, headache, sweating, insomnia, pain at the injection site for XR-BUP; similar effects plus mouth numbness or irritation may occur with SL-BUP.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have a moderate to severe opioid use disorder or am on buprenorphine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Comparative effectiveness

Secondary study objectives

Acceptability of XR-BUP

Feasibility of study implementation

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: Injectable extended-release buprenorphine (XR-BUP)Experimental Treatment1 Intervention

Participants will be randomly assigned to XR-BUP, with approximately 96 in the XR-BUP condition. The XR-BUP condition will use Brixadi/CAM2038 injectable, extended-release buprenorphine (Braeburn Pharmaceuticals, Inc.). After titrating to a stable dosage in approximately two weeks using weekly injection dosages as clinically indicated to relieve cravings and withdrawal symptoms, the target monthly dosage (128mg) of XR-BUP will be administered by injection at approximately Day 14 and approximately four weeks later in Week 6, with a third injection in Week 10. Dosage adjustments will be made as indicated for tolerability.

Group II: Sublingual buprenorphine-naloxone (SL-BUP)Active Control1 Intervention

Participants will be randomly assigned to SL-BUP with approximately 48 in the SL-BUP condition. The SL-BUP condition will use sublingual buprenorphine-naloxone, with a target maintenance daily dose range of 16-24mg as recommended for clinical practice. Titration to maintenance dosage will be attempted within the first two weeks of the SL-BUP condition. During the initial stabilization weeks, SL-BUP will be flexibly dosed as clinically indicated to relieve cravings and withdrawal symptoms, after which dosage adjustments will be based on clinical decisions by the site clinicians. The maintenance dosage of SL-BUP will be dispensed on a schedule similar to the XR-BUP injections (i.e., at approximately Day 14, Week 6, and Week 10).

0 / 2Eligibility criteria met