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Semaglutide for Opioid Recovery Study

This study is testing if semaglutide, an FDA-approved medication, can help people with severe opioid use disorder (OUD) reduce their cravings for opioids. You would be eligible if you are an English-speaking adult, 18 or older, have a severe OUD diagnosis, and have recently started or are stable on buprenorphine (SL-BUP) treatment. The study aims to see how semaglutide affects cravings and if it's safe and well-tolerated. We are looking for 46 participants, and the current recruitment status is unclear.

Study design
This is a 12-week, double-blind (neither you nor your doctor will know if you're getting the study drug), placebo-controlled (some participants receive an inactive substance), randomized study with 46 participants.
What's involved
You would have 13 weekly study visits, each lasting about 1 hour, with three visits potentially up to 3 hours. These visits include vital signs, weight, urine and blood tests, and questionnaires.
Compensation
Not stated in the trial record.
Follow-up
Your cravings and illicit opioid use will be monitored weekly for 14 weeks after your baseline visit.

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NCT06639464

Semaglutide for Helping Opioid Recovery

Recruiting
PHASE2Ages 18+InterventionalTreatment
Brigham and Women's Hospital
~46 participants
Updated 2025-09-26 on ClinicalTrials.gov
What's tested:SemaglutidePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cue-induced Cravings for Opioids
Measured over Baseline, 6 weeks, and 13 weeks after baseline visit
+1 more outcome measured

Conditions

Opioid Use Disorder

Explore related trials

Opioid Use Disorder

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Joji Suzuki
[email protected]
617-732-5752
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

What this trial measures

  • Cue-induced Cravings for OpioidsBaseline, 6 weeks, and 13 weeks after baseline visit

    Cue-induced craving scores at study completion compared to baseline using a standard cue-reactivity paradigm utilizing visual cues. Cravings will be measured on a scale from 0-10 with 10 meaning extreme cravings.

  • Relapse to Illicit Opioid UseWeekly from baseline to end of study at 14 weeks

    the primary outcome is proportion of participants who relapse to illicit opioids use at study completion, defined as the start of 4 consecutive opioid "use weeks" or at the start of 7 consecutive days of self-reported opioid use days. A "use week" is defined as any week in which participants self-report at least one day of illicit opioid use, provide a urine test positive for illicit opioids, or fail to provide a urine sample for testing. The study investigators will use Time-Line Follow Back (TLFB), a gold-standard method of evaluating substance use, as well as weekly urine toxicology screens.