Actively Recruiting
Evaluation Of Semaglutide Safety and Tolerability 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
34 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
This research evaluates the safety and tolerability of semaglutide in adults with cocaine use disorder, including those with and without HIV. The study also aims to see if semaglutide affects cocaine use, craving, risk behaviors, mood, and certain health biomarkers. This is a 16-week, double-blind, placebo-controlled pilot study with dose escalation for semaglutide. Participants are randomly assigned to receive either weekly injections of semaglutide or a placebo. The semaglutide dose begins at 0.25 mg and may increase to a maximum of 2.0 mg if tolerated. Study visits include weekly injections and biweekly lab work, assessments, and surveys. Participants who agree may also complete optional MRI scans before starting treatment and near the study end. During the study, participants will have regular medical exams, clinical assessments, and lab tests to monitor health and drug effects. Researchers will track safety, tolerability, cocaine use patterns, mood changes, body composition, inflammatory and heart-related biomarkers, and brain function. The entire study duration is 16 weeks, with a final assessment at the end.
CONDITIONS
Brief 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
- English proficiency
- In people of childbearing potential, agree to use an acceptable method of birth control
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
- Being prescribed glucose-lowering medications
- Estimated glomerular filtration rate less than 45 ml/min
- Lifetime history of taking semaglutide or other GLP-1 receptor agonists
- Current suicidal ideation or suicide attempts within the past 24 months
- Present diagnosis of diabetes mellitus or hemoglobin A1C 6.5 or higher
- Use of weight-lowering medications
- History of gastric bypass surgery
- History of myocardial infarction or stroke within the past 12 months
- Pregnant, breastfeeding, or intending to become pregnant within four months
- Any contraindicated medical issues identified by study investigators
- Risks associated with OZEMPIC and WEGOVY warnings including hypoglycemia, gastroparesis, or pancreatic disease
- Calcitonin value equal to or above 50 ng/L
- Claustrophobia or physical issues preventing MRI scan (if completing MRI portion)
- Presence of metal devices in the body (e.g., pacemaker, infusion pump, aneurysm clip, metal prosthesis or plate) if completing MRI portion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive once weekly injections of semaglutide or placebo and complete lab work, medical examinations, clinical assessments, and surveys during the 16-week treatment period.
Weekly visits for injections and assessments
Duration - At Week 16
Participants complete a final assessment at Week 16 to evaluate safety, tolerability, and drug use outcomes.
1 visit (in-person)
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
S
Sarah Kattakuzhy
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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