Semaglutide to support recovery from opioid use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a double-blind, placebo-controlled, randomized pilot enrolling 46 adults with DSM-5 opioid use disorder who have been on a stable sublingual buprenorphine dose for at least 30 days. Participants are randomized 1:1 to weekly semaglutide injections or matching placebo for 12 weeks with 13 scheduled visits that include neurocognitive testing for reward- and stress-related cue-reactivity, vitals, urine toxicology, and blood draws. The trial collects safety and tolerability data, measures of craving and withdrawal, mood symptoms, and blood biomarkers at baseline, mid-treatment, and end of study. Both participants and study staff are blinded to treatment assignment to limit bias.

Why it matters

Who can join: the full rules

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

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Joji Suzuki
• Email: jsuzuki2@bwh.harvard.edu
• Phone: 617-732-5752

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CBD for Opioid Dependence and Pain on Buprenorphine

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• Cebranopadol for opioid withdrawal in adults with chronic pain

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• emPath platform pilot to link and keep adults with opioid use disorder in care in Durham

  This pilot tests a mobile app and telemedicine approach to help adults with opioid use disorder start and stay in MOUD through community outreach in Durham, NC.

  Recruiting Duke University · Durham, North Carolina · NCT07810322

• CB1 Receptors in Opioid Use Disorder Measured with a PET Radioligand

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• STORC: Training a support person plus patient navigation after birth

  We’re testing whether training a designated support person and using patient navigation after delivery helps people with opioid use disorder build recovery resources and stay in treatment.

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• Personalized Addiction Treatment Enhancement for Opioid Use Disorder

  A digital platform run by peer recovery supporters will be tested to help adults with opioid use disorder who are on buprenorphine or methadone stay in treatment and improve outcomes.

  Recruiting Rhode Island Hospital · Providence, Rhode Island · NCT07778394

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.