GLP-1R Agonist Treatment for Opioid Use Disorder

Summary

The goal of this clinical trial is to learn if semaglutide can reduce illicit opioid use in adults in outpatient treatment for opioid use disorder, and who are receiving either buprenorphine or methadone maintenance treatment. The main question it aims to answer is:

• Does semaglutide increase the likelihood that participants will refrain from using illicit and nonprescribed opioids?

The investigators will compare semaglutide to a placebo (a needle prick that contains no drug) to see if semaglutide works to reduce use of illicit and nonprescribed opioids.

The participants will:

* Take semaglutide or a placebo every week for 12 weeks
* Visit the clinic every week for urine drug screening and pregnancy testing, vital signs, and to complete mental health and drug use questionnaires
* Complete smartphone surveys sent at set times during the study

Conditions

• Opioid Use Disorder
• Opioid Abuse and Addiction
• Narcotic-Related Disorders
• Substance-Related Disorders
• Chemically-Induced Disorders
• Mental Disorder
• Opioid

Interventions

DRUG

Semaglutide Pen Injector

Semaglutide will be provided using an injection pen

DRUG

Placebo

Placebo will be a dry needle stick; no substances will be injected

Sponsors & Collaborators

• New York University

  collaborator OTHER

• University of Maryland

  collaborator OTHER

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Milton S. Hershey Medical Center

  lead OTHER

Principal Investigators

• Jennifer Nyland, PhD · Milton S. Hershey Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-13

Primary Completion

2026-11-30

Completion

2026-11-30

FDA Drug

Yes

Countries

• United States

Study Locations