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

Sep, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

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

Sep 26, 2025

Last verified

Sep, 2025

Keywords

  • semaglutide
  • opioid use disorder
  • buprenorphine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-09-26.