Actively Recruiting
Evaluation Of Semaglutide in Adults With Cocaine Use Disorder With and Without HIV
Led by University of Maryland, Baltimore · Updated on 2025-08-24
40
Participants Needed
2
Research Sites
81 weeks
Total Duration
On this page
Sponsors
U
University of Maryland, Baltimore
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Evaluation Of Semaglutide in Adults With Cocaine Use Disorder With and Without HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- Meet criteria for cocaine use disorder 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
- Proficient in English
- Agree to use acceptable birth control if of childbearing potential
You will not qualify if you...
- Triglycerides greater than 500 mg/dL
- History of gall bladder disease
- Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- History of diabetic retinopathy
- Currently prescribed glucose-lowering medications
- Estimated glomerular filtration rate less than 45 ml/min
- Lifetime use of semaglutide or other GLP-1 receptor agonists
- Current suicidal thoughts or attempts within past 24 months
- Diagnosis of diabetes mellitus or hemoglobin A1C 6.5 or higher
- Use of weight-lowering medications
- History of gastric bypass surgery
- History of heart attack or stroke within past 12 months
- Pregnant, breastfeeding, or planning pregnancy within 4 months
- Any medical issues contraindicated by study investigators
- Risk of conditions listed under Warning and Precautions of OZEMPIC and WEGOVY including hypoglycemia, gastroparesis, or pancreatic disease
- Calcitonin value 50 ng/L or above
- Claustrophobia or physical issues preventing MRI if participating in MRI portion
- Presence of metal devices in body preventing MRI if participating in MRI portion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Institute of Human Virology at the University of Maryland School of Medicine
Washington D.C., District of Columbia, United States, 20002
Actively Recruiting
2
Institute of Human Virology at the University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
O
Onyinyechi Ogbumbadiugha-Weekes
CONTACT
S
Sarah Kattakuzhy
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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