NCT06691243Active, not recruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 10 Sept 2026

Brief summary (registry, in English)

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

Status (registry): Active, not recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 40 (estimated)
First submitted: 6 Nov 2024
Start date: 7 Aug 2025
Primary completion date: Jan 2027
Lead sponsor: University of Maryland, Baltimore
Diseases: HIV
NCT number: NCT06691243

What you commit to

Study type: Interventional · Phase 2
Planned participants: 40
From 7 Aug 2025 to the primary completion date, Jan 2027
2 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Use of weight-lowering medications

Other illness

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
Lifetime history of taking semaglutide or other GLP-1 RAs
History of gastric bypass surgery
History of myocardial infarction or stroke within the past 12 months
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.

Lab values

Triglycerides \> 500 mg/dL
Being prescribed glucose-lowering medications
Present diagnosis of diabetes mellitus OR screening hemoglobin A1C \>/= 6.5

Other

An estimated glomerular filtration rate of less than 45 ml/min
Current suicidal ideation or suicide attempts within the past 24 months
Pregnant, breastfeeding, or the patient intends to become pregnant during the next four months
Any contraindicated medical issues identified by the study investigators
Calcitonin value equal to or above 50 ng/L
If completing the MRI portion of the study: claustrophobia or physical issues preventing MRI scan
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

Who the study is looking for

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
English proficiency
In people of childbearing potential, agree to use an acceptable method of birth control

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Institute of Human Virology at the University of Maryland School of Medicine Coordinator of this site? Confirm its status	Baltimore	United States	Unknown status
Institute of Human Virology at the University of Maryland School of Medicine Coordinator of this site? Confirm its status	Washington D.C.	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.