RECRUITING Phase 2 ClinicalTrials.gov

Semaglutide for Helping Opioid Recovery

Sponsor: Brigham and Women's Hospital • ClinicalTrials.gov ID: NCT06639464

Registry updated: 2026-10-13

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Description

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.

Interventions

Semaglutide (Drug)
This intervention will consist of the FDA-approved dosing schedule, with terminal dosage based on manufacturer's recommendation to titrate to 1mg over 12 weeks. Participants will receive 0.25mg for the first 4 weeks, 0.5mg for the next 4 weeks, and 1.0mg for the final 4 weeks. IDS will extract semaglutide an draw the doses into syringes for matching placebo doses to also be produced and maintain blind.
Placebo (Other)
Placebo syringes of saline and matching volume will be produced by IDS.

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

Conditions

Opioid Use Disorder

Locations

Brigham and Women's Hospital — Boston, Massachusetts, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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