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Semaglutide for Helping Opioid Recovery

RecruitingPhase 2

Semaglutide for the Treatment of Opioid Use Disorder: A Pilot Randomized Controlled Trial

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria

* English-speaking adults aged 18 or older
* DSM-5 diagnosis of severe opioid use disorder (OUD)
* Receiving buprenorphine ≥16 mg/day or methadone ≥70 mg/day for at least 30 days prior to enrollment
* Planning to continue buprenorphine or methadone treatment throughout the study
* Willing to bring buprenorphine prescriptions to visits for dose counts (if applicable)
* Willing to authorize communication between the study team and their MOUD prescriber via a 42 CFR release

Exclusion Criteria

* Active psychosis, suicidality, homicidality, or psychiatric conditions impairing capacity to consent
* Current or lifetime history of an eating disorder
* BMI \<21 kg/m²
* Current or lifetime diagnosis of Type 1 or Type 2 diabetes
* Personal or family history of medullary thyroid carcinoma or MEN2
* GLP-1 receptor agonist use within the past 3 months or anticipated use during the study
* Myocardial infarction, stroke, unstable angina, or congestive heart failure within the past 90 days
* Persistently elevated BP (\>160 mmHg systolic or \>100 mmHg diastolic) during screening
* History of inflammatory bowel disease, bariatric surgery, idiopathic pancreatitis, or diabetic gastroparesis
* Liver function tests \>3x the upper limit of normal or eGFR \<30
* History of hypersensitivity or allergy to semaglutide
* Pregnancy or breastfeeding
* Anticipated participation in another investigational drug trial
* Any other condition that investigators determine may interfere with participation or pose a safety concern

About the study

The is a pilot, 12-week, double-blind, placebo-controlled, randomized trial of individuals with opioid use disorder (OUD) newly initiating buprenorphine to receive either weekly injections of semaglutide (n=23) or matching placebo (n=23). The primary aim is to determine the effects of semaglutide on cue-reactivity among individuals with OUD. The secondary aim is to assess the preliminary efficacy, safety, and tolerability of semaglutide for OUD.

What is being tested

Sponsor: Brigham and Women's Hospital · Participants: 46 · Started: Jun 2, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06639464

Locations in the U.S.

MassachusettsBrigham and Women's Hospital, Boston

Conditions

From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.