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

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byYih-Ing Hser, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Yih-Ing Hser

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This pilot trial will explore the feasibility, acceptability, and effectiveness of the most recently approved formulation of injectable extended-release buprenorphine (XR-BUP) for treatment of opioid use disorder (OUD) in rural settings. We will randomize 144 eligible individuals with moderate to severe OUD in a 2:1 ratio to one of two medication conditions: (1) XR-BUP (128mg target), administered every 4 weeks or (2) SL-BUP (16mg-24 mg/day target).Participants will receive study medication treatment for the 14 week-intervention period, including an initial \~2-week period of induction/stabilization. The study will use a mixed-methods approach (participant assessments, study medication records, qualitative interviews) for assessing feasibility and acceptability, and results will include patient outcome data on the comparative effectiveness of XR-BUP versus SL-BUP for patients with OUD in rural settings.

Eligibility Criteria

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.

Inclusion Criteria

Be willing and able to provide written informed consent to participate in the study

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

I am 18 years old or older.

+6 more

Exclusion Criteria

Have a current pattern of alcohol, benzodiazepine, or other sedative hypnotic use, as determined by the study Medical Clinician, that would require a different level of care and preclude safe participation in the study

Have been in methadone maintenance treatment within 28 days of consent

Be currently incarcerated or have pending legal action that could preclude participation in study activities

+8 more

Participant Groups

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.

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).