NCT06691243

Evaluation Of Semaglutide in Adults With Cocaine Use Disorder With and Without HIV

Evaluation Of Semaglutide Safety and Tolerability in Adults With Cocaine Use Disorder With and Without HIV

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to find out if semaglutide is safe and well tolerated in adults with cocaine use disorder who do and do not have human immunodeficiency virus (HIV). Participants will complete a screening process and if you are able to participate, you will be assigned to one of two treatment groups: semaglutide or placebo. Participants will: * Visit the clinic once a week for semaglutide or placebo injections * Visit the clinic once every two weeks for labwork, assessments and/or surveys * If consented to optional MRI's, complete two MRI's

Detailed description

STAC is a 16-week, double-blind, placebo-controlled, pilot, dose-escalation study that aims to determine the dose of semaglutide that is safe and tolerable in individuals with cocaine use disorder, including those with and without HIV; whether semaglutide improves drug use outcomes for cocaine use; and whether semaglutide improves cardiac and inflammatory biomarkers. Interested participants will be consented and screened, and after screening process is completed, all eligible participants who desire to continue with the study will be randomized either to semaglutide injections or placebo injections. Participants will receive semaglutide or placebo injections once a week from Day 0 through Week 16, and a final assessment will be completed at Week 16. Study visits will also intermittently complete labwork, medical examinations, clinical assessments and surveys. Participants who consent to the optional MRI visits, will also complete MRI's at two timepoints: once before starting the study medication and once near Week 16.

Conditions

• Cocaine Use Disorder
• HIV

Interventions

Type	Name	Description
DRUG	Semaglutide	The initial dose will be semaglutide 0.25mg which, if tolerated, will be escalated to 0.5mg. Escalation will continue to 1.0 mg and afterwards to 2.0 mg. The highest possible dose will be 2.0mg semaglutide.
DRUG	Placebo	Patients randomized to placebo arm will receive placebo injection every week.

Timeline

• Start date: 2025-08-07
• Primary completion: 2026-07-01
• Completion: 2027-03-01
• First posted: 2024-11-15
• Last updated: 2025-08-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study