Evaluation Of Semaglutide Safety and Tolerability in Adults With Cocaine Use Disorder With and Without HIV
University of Maryland, Baltimore
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
Description
STAC is a 16-week, double-blind, placebo-controlled, pilot, dose-escalation study that aims to determine the dose of semaglutide that is safe and tolerable in individuals with cocaine use disorder, including those with and without HIV; whether semaglutide improves drug use outcomes for cocaine use; and whether semaglutide improves cardiac and inflammatory biomarkers. 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 injec…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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 retinop…
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 MedicineWashington D.C., District of Columbia
- Institute of Human Virology at the University of Maryland School of MedicineBaltimore, Maryland