Semaglutide for the Treatment of Opioid Use Disorder: A Pilot Randomized Controlled Trial
Brigham and Women's Hospital
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.
Description
Participants include N=46 men and women with DSM5 diagnosis of OUD who are newly initiating sublingual buprenorphine (SL-BUP), defined as within 60 days of enrollment. Only those participants who have attained stable SL-BUP dosing (i.e. no change in dose) for at least 30 days prior to enrollment and plan to remain on the SL-BUP for the duration of the trial will be eligible. Potential participants will be screened and enrolled only if they meet full inclusion criteria. After baseline procedures are complete, participants will be randomized to semaglutide or placebo. Following randomization, pa…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 Individu…
Interventions
- DrugSemaglutide
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.
- OtherPlacebo
Placebo syringes of saline and matching volume will be produced by IDS.
Location
- Brigham and Women's HospitalBoston, Massachusetts