Extended-release Buprenorphine Compared to Sublingual Buprenorphine in Rural Settings (RXR)

Summary

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.

Conditions

• Opioid-Related Disorders
• Substance-Related Disorders
• Narcotic-Related Disorders

Interventions

DRUG

Injectable extended-release buprenorphine

Participants randomized to the XR-BUP condition will receive XR-BUP study medication for approximately 14 weeks following randomization, including an initial \~2-week period of induction/stabilization.

DRUG

Sublingual buprenorphine-naloxone

Participants randomized to the SL-BUP condition will receive SL-BUP study medication for approximately 14 weeks following randomization, including an initial \~2-week period of induction/stabilization.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• National Institutes of Health (NIH)

  collaborator NIH

• The Emmes Company, LLC

  collaborator INDUSTRY

• University of California, Los Angeles

  collaborator OTHER

• RAND

  collaborator OTHER

• Cornell University

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• University of Illinois at Chicago

  collaborator OTHER

• University of Washington

  collaborator OTHER

• West Virginia University

  collaborator OTHER

• Yih-Ing Hser

  lead OTHER

Principal Investigators

• Yih-Ing Hser, PhD · University of California, Los Angeles

• Larissa Mooney, MD · University of California, Los Angeles

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-14

Primary Completion

2025-11-04

Completion

2026-01-14

FDA Drug

Yes

Countries

• United States

Study Locations