What this trial means for you
This study is recruiting now at 2 US sites. It's studying Semaglutide, Placebo for cocaine use disorder, hiv.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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
Study sites by state
District of Columbia
- Institute of Human Virology at the University of Maryland School of Medicine — Washington D.C. · Recruiting now
Maryland
- Institute of Human Virology at the University of Maryland School of Medicine — Baltimore · Recruiting now
View the official record on ClinicalTrials.gov →
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