Semaglutide for 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

This trial tests whether weekly semaglutide injections are safe and help reduce cocaine use in adults with cocaine use disorder, including people living with HIV.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Maryland, Baltimore (Academic / other)
• Locations: 2 sites (Washington D.C., District of Columbia and 1 other locations)
• Trial ID: NCT06691243 on ClinicalTrials.gov

What this trial studies

STAC is a 16-week, double-blind, placebo-controlled pilot with dose escalation that randomizes eligible adults with cocaine use disorder, with and without HIV, to weekly semaglutide or placebo injections. Participants attend weekly clinic visits for injections and biweekly visits for lab work, exams, assessments, and surveys, with a final assessment at Week 16. Optional MRI scans are performed for those who consent at baseline and near Week 16 to study brain effects. The trial also measures cardiac and inflammatory biomarkers alongside clinical measures of cocaine use to evaluate safety, tolerability, and preliminary signals of benefit.

Who should consider this trial

Good fit: Adults aged 18 or older who meet DSM-5 criteria for cocaine use disorder, have used cocaine at least 7 of the past 14 days, have a BMI of 20–50 kg/m2, are English proficient, and meet other screening criteria (including not having diabetes or prior GLP-1 use) are ideal candidates.

Not a fit: People with current diabetes, prior use of semaglutide or other GLP-1 receptor agonists, certain endocrine or gallbladder conditions, very high triglycerides, low kidney function, or those on weight-lowering medications may not be eligible and are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, semaglutide could provide a new medication option that reduces cocaine use and improves related cardiac and inflammatory markers in adults with cocaine use disorder.

How similar studies have performed: Preclinical studies and early human work suggest GLP-1 receptor agonists can reduce stimulant-related behaviors, but clinical evidence for semaglutide specifically in cocaine use disorder is limited and this approach remains experimental.

Eligibility criteria

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

Where this trial is running

Washington D.C., District of Columbia and 1 other locations

• Institute of Human Virology at the University of Maryland School of Medicine — Washington D.C., District of Columbia, United States (Recruiting)
• Institute of Human Virology at the University of Maryland School of Medicine — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Study coordinator: Onyinyechi Ogbumbadiugha-Weekes

Conditions Cocaine Use Disorder; HIV; semaglutide; GLP-1; cocaine use disorder