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

What Was Tested

This registered phase 2 trial tested Semaglutide.

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.

It had two arms (groups): Semaglutide (experimental) and Placebo (placebo comparator).

Once weekly injection of semaglutide.

Once weekly injection of placebo.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

Enrollment: 40 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: At least 18 years old. Meet criteria for CUD according to the Diagnostic and Statistical Manual Version 5. Used cocaine at least 7 out of the past 14 days. Body Mass Index between 20 - 50 kg/m2. In people of childbearing potential, agree to use an acceptable method of birth control.

The full record lists 6 inclusion and 18 exclusion criteria; among the exclusions: history of gall bladder disease; personal or family history of medullary thyroid carcinoma, or patients with a history of multiple endocrine neoplasia syndrome type 2 (men 2); history of diabetic retinopathy.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

The Semaglutide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2025-08-07 with completion listed for 2027-01.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Safety of semaglutide in patients with cocaine use disorder (CUD) with and without HIV (time frame: 16 weeks). Tolerability of semaglutide in patients with cocaine use disorder (CUD) with and without HIV (time frame: 16 weeks).

It also tracked 20 secondary outcomes, for example Determine if semaglutide impacts depression in people with cocaine use disorder, with and without HIV, Determine if semaglutide impacts anxiety in people with cocaine use disorder, with and without HIV, Determine if semaglutide impacts anhedonia in people with cocaine use disorder, with and without HIV, Determine if semaglutide impacts sleep in people with cocaine use disorder, with and without HIV, Determine if semaglutide impacts sexual desire in people with cocaine use disorder, with and without HIV and Determine if semaglutide impacts food cravings in people with cocaine use disorder, with and without HIV.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 40 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.