Semaglutide for Helping Opioid Recovery

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06639464
Phase
PHASE2
Status
Recruiting
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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide — DRUG
    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 — OTHER
    Placebo syringes of saline and matching volume will be produced by IDS.

Study Details

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.

Key Dates

Start date
Jun 2, 2025
Status verified
Sep 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
46 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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).

Primary Outcome Measure

Cue-induced Cravings for Opioids [ Time Frame: Baseline, 6 weeks, and 13 weeks after baseline visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Joji Suzuki, MD
[email protected]
617-732-5752
Joji Suzuki, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Brigham and Women's Hospital· Boston, MA

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