Semaglutide for Helping Opioid Recovery
Semaglutide for the Treatment of Opioid Use Disorder: A Pilot Randomized Controlled Trial
Brigham and Women's Hospital
46 participants
Jun 2, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria23
- 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
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Interventions
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 syringes of saline and matching volume will be produced by IDS.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06639464