Semaglutide for the Treatment of Opioid Use Disorder: A Pilot Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Contact Information
Primary
Joji Suzuki
jsuzuki2@bwh.harvard.edu
617-732-5752
Time Frame
Start Date: 2025-06-02
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 46
Treatments
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).
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital

This content was sourced from clinicaltrials.gov

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