Recruiting
Phase 2

Semaglutide

Sponsor:

Brigham and Women's Hospital

Code:

NCT06639464

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Semaglutide

Placebo

Study Details

Brief 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.

Conditions

Opioid Use Disorder

Study ID

NCT06639464

Start date

Jun 2, 2025

Status verified date

Oct, 2026

Completion date

Sep 15, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

46 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Semaglutide

This arm will receive semaglutide (n=23). All participants will initially receive 0.25mg for 4 weeks, and then as tolerated dose will be increased to 0.5mg for 4 weeks. Then as tolerated, the dose will be increased to 1.0mg for 4 weeks.

placebo comparator: Placebo

This arm will receive saline placebo (n=23).

Interventions

Semaglutide

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

Placebo syringes of saline and matching volume will be produced by IDS.

Primary outcome measure

  • Cue-induced Cravings for Opioids [ Time Frame: Baseline, 6 weeks, and 13 weeks after baseline visit ]
  • Relapse to Illicit Opioid Use [ Time Frame: Weekly from baseline to end of study at 14 weeks ]

Central Contacts and Locations

Central contacts

Joji Suzuki

617-732-5752jsuzuki2@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Joji Suzuki, MD

617-732-5752jsuzuki2@bwh.harvard.edu

Principal Investigator:

Joji Suzuki, MD

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

  • semaglutide
  • opioid use disorder
  • buprenorphine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.