Actively Recruiting
Semaglutide for Helping Opioid Recovery
Led by Brigham and Women's Hospital · Updated on 2025-09-26
46
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Semaglutide for Helping Opioid Recovery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- English speaking adults aged 18 and above
- Severe opioid use disorder diagnosed by DSM-5
- Started sublingual buprenorphine treatment within 60 days before enrollment
- Stable sublingual buprenorphine dose of 16 mg or more for at least 30 days before enrollment
- Plan to continue sublingual buprenorphine for the entire trial duration
- Agree to bring sublingual buprenorphine prescription to study visits for dose count
- Willing to allow study team to communicate with community prescriber about buprenorphine treatment
You will not qualify if you...
- Diagnosis of current substance use disorder other than opioid, cannabis, or tobacco
- Active psychosis, active suicidality or homicidality, or psychiatric conditions impairing informed consent
- Current or past diagnosis of eating disorders
- Body mass index less than 25 mg/kg2
- Current or past 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 GLP-1 agonist medications within the past 3 months
- Planning to receive 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, or diabetic gastroparesis
- Liver function tests greater than three times the upper normal limit
- Kidney impairment with estimated glomerular filtration rate below 60
- Allergy or hypersensitivity to semaglutide
- Pregnant or breastfeeding
- Planning to participate in another drug trial concurrently
- Any other medical condition or reason that may interfere with safe participation or study procedures
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
J
Joji Suzuki
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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