Semaglutide to support recovery from opioid use disorder
Semaglutide for the Treatment of Opioid Use Disorder: A Pilot Randomized Controlled Trial
This 12-week test tries weekly semaglutide injections in people with opioid use disorder who recently started buprenorphine to see if it reduces cue-reactivity and improves symptoms and safety measures.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06639464 on ClinicalTrials.gov |
What this trial studies
This is a double-blind, placebo-controlled, randomized pilot enrolling 46 adults with DSM-5 opioid use disorder who have been on a stable sublingual buprenorphine dose for at least 30 days. Participants are randomized 1:1 to weekly semaglutide injections or matching placebo for 12 weeks with 13 scheduled visits that include neurocognitive testing for reward- and stress-related cue-reactivity, vitals, urine toxicology, and blood draws. The trial collects safety and tolerability data, measures of craving and withdrawal, mood symptoms, and blood biomarkers at baseline, mid-treatment, and end of study. Both participants and study staff are blinded to treatment assignment to limit bias.
Who should consider this trial
Good fit: Adults (18+) with severe DSM-5 opioid use disorder who initiated sublingual buprenorphine within 60 days, have been on a stable buprenorphine dose of 16 mg or greater for at least 30 days, and are willing to attend weekly visits and allow communication with their buprenorphine prescriber.
Not a fit: People with current substance use disorders other than opioid/cannabis/tobacco, active psychosis or suicidality, any current or past eating disorder, BMI under 25, or uncontrolled diabetes are excluded and therefore unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, semaglutide could reduce cue-driven craving and improve treatment outcomes for people starting buprenorphine for opioid use disorder.
How similar studies have performed: Preclinical work and early human studies of GLP-1 receptor agonists suggest potential to reduce drug-related cue-reactivity, but using semaglutide specifically for opioid use disorder is a novel, early pilot approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Joji Suzuki
- Email: jsuzuki2@bwh.harvard.edu
- Phone: 617-732-5752
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.