Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06639464

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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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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