Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment.

Summary

The purpose of this clinical trial is to compare the effectiveness of office-based methadone with pharmacy administration and/or dispensing to office-based buprenorphine for the treatment of opioid use disorder. This study will also examine factors influencing the implementation of office-based methadone.

Conditions

• Opioid Use Disorder

Interventions

DRUG

Methadone

Drug: Methadone Possible formulations: 10 and 50 mg tablets

DRUG

Buprenorphine (BUP)

Drug: Buprenorphine (BUP) Possible formulations: A. Buprenorphine 225 mcg to 24 mg 225 mcg to 32 mg per day B. Buprenorphine (Extended release) 300 mg q 28 days (Sublocade) 100 mg q 28 days (Sublocade) 8 mg q 7 days (Brixadi) 16 mg q 7 days (Brixadi) 24 mg q 7 days (Brixadi) 32 mg q 7 days (Brixadi) 64 mg q 7 28 days (Brixadi) 96 mg q 7 28 days (Brixadi) 128 mg q 7 28 days (Brixadi)

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• The Emmes Company, LLC

  collaborator INDUSTRY

• University of California, San Francisco

  collaborator OTHER

• Boston Medical Center (BMC)

  collaborator UNKNOWN

• Hennepin Healthcare Research Institute

  collaborator OTHER

• Alameda Health System

  collaborator OTHER

• Marshall Health

  collaborator UNKNOWN

• Kaiser Permanente

  collaborator OTHER

• Yale University

  lead OTHER

Principal Investigators

• David Fiellin, MD · Yale University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-04

Primary Completion

2028-12-31

Completion

2028-12-31

FDA Drug

Yes

Countries

• United States

Study Locations