RecruitingPhase 2NCT06691243

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


Sponsor

University of Maryland, Baltimore

Enrollment

40 participants

Start Date

Aug 7, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether semaglutide — a medication approved for type 2 diabetes and weight loss (brand name Ozempic/Wegovy) — can also reduce cocaine use in adults with cocaine use disorder, including those living with HIV. Early research suggests GLP-1 drugs like semaglutide may reduce cravings for addictive substances. **You may be eligible if...** - You are 18 or older - You meet the criteria for cocaine use disorder (a pattern of problematic cocaine use) - You have used cocaine at least 7 out of the past 14 days - Your BMI is between 20 and 50 - You can communicate in English - You agree to use effective birth control if you could become pregnant **You may NOT be eligible if...** - You have very high triglyceride levels (above 500 mg/dL) - You have a history of gallbladder disease or pancreatitis - You or a close family member has had a specific type of thyroid cancer (medullary thyroid carcinoma) - You have multiple endocrine neoplasia type 2 (a rare hormonal condition) - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSemaglutide

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.

DRUGPlacebo

Patients randomized to placebo arm will receive placebo injection every week.


Locations(2)

Institute of Human Virology at the University of Maryland School of Medicine

Washington D.C., District of Columbia, United States

Institute of Human Virology at the University of Maryland School of Medicine

Baltimore, Maryland, United States

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NCT06691243


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