Clinical trial

Semaglutide for Helping Opioid Recovery

Recruiting now · Phase 2 · 1 countries · Registry ID NCT06639464

Recruiting nowPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionOpioid Use Disorder

Full registry 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

Treatments and study arms

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.

Primary outcomes

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Brigham and Women's Hospital🇺🇸 Boston, Massachusetts, United States

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Joji Suzuki, MDContact

Email · Call 617-732-5752

Joji Suzuki, MDPrincipal Investigator