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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 and above
* DSM-5 diagnosis of opioid use disorder, severe
* Initiated sublingual buprenorphine (SL-BUP) treatment within 60 days of enrollment
* Attained stable dosing of SL-BUP of 16mg or greater for 30 days prior to enrollment
* Anticipating continuation of SL-BUP for the duration of the trial
* Agreeable with bringing SL-BUP prescription to visits to allow study team to conduct a dose count
* Willing to grant study team permission to communicate about SL-BUP treatment with community prescriber via completion of 42 CFR release

Individuals with any of the following will be excluded:

* DSM-5 diagnosis of any current substance use disorder excluding opioid, cannabis or tobacco
* Active psychosis, active suicidality or homicidality or any psychiatric condition that impair ability to provide informed consent
* Any current or lifetime diagnosis of eating disorders
* BMI\<25mg/kg2
* Current or lifetime diagnosis of Type 1 or Type 2 diabetes
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
* Use of any GLP-1 agonist medications in the prior 3 months
* Anticipating receipt of any GLP-1 agonist medications during the trial
* History of angina pectoris, coronary heart disease, congestive heart failure, inflammatory bowel disease, chronic obstructive pulmonary disease, bariatric surgery, idiopathic pancreatitis, diabetic gastroparesis
* Liver function test greater than 3 times upper normal limit
* Renal impairment as indicated by eGFR of \<60
* History of hypersensitivity or allergy to semaglutide
* Pregnant or breastfeeding
* Anticipated to participate in a concurrent drug trial
* Any other reason or clinical condition that the investigators judge may interfere with study participation and/or be unsafe for a participant

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 Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.