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Evaluation of semaglutide safety and tolerability in adults with cocaine use disorder with and without HIV

NCT ID NCT06691243

NEW Sponsor: University of Maryland, Baltimore Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 10, 2026

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

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. At least 18 years old 2. Meet criteria for CUD according to the Diagnostic and Statistical Manual Version 5 3. Used cocaine at least 7 out of the past 14 days 4. Body Mass Index between 20 - 50 kg/m2 5. English proficiency 6. In people of childbearing potential, agree to use an acceptable method of birth control Exclusion Criteria: 1. Triglycerides \> 500 mg/dL 2. History of gall bladder disease 3. Personal or family history of medullary thyroid carcinoma, or patients with a history of Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) 4. History of diabetic retinopathy 5. Being prescribed glucose-lowering medications 6. An estimated glomerular filtration rate of less than 45 ml/min 7. Lifetime history of taking semaglutide or other GLP-1 RAs 8. Current suicidal ideation or suicide attempts within the past 24 months 9. Present diagnosis of diabetes mellitus OR screening hemoglobin A1C \>/= 6.5 10. Use of weight-lowering medications 11. History of gastric bypass surgery 12. History of myocardial infarction or stroke within the past 12 months 13. Pregnant, breastfeeding, or the patient intends to become pregnant during the next four months 14. Any contraindicated medical issues identified by the study investigators 15. Risk of conditions that are under Warning and Precautions section of OZEMPIC and WEGOVY including but not limited to known history or current report of clinically relevant hypoglycemia, gastroparesis, or pancreatic disease. 16. Calcitonin value equal to or above 50 ng/L 17. If completing the MRI portion of the study: claustrophobia or physical issues preventing MRI scan 18. If completing the MRI portion of the study: presence of a metal device in the body (e.g. pacemaker. Infusion pump, aneurysm clip, metal prosthesis or plate

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Conditions

The condition(s) this trial relates to.

cocaine dependence HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cocaine use disorder HIV

Contacts and locations

Locations

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

    Washington D.C., District of Columbia, 20002, United States

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

    Baltimore, Maryland, 21201, United States

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