Evaluation Of Semaglutide in Adults With Cocaine Use Disorder With and Without HIV
Recruiting · NCT06691243 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Maryland, Baltimore
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboSemaglutide
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
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- At least 18 years old
- Meet criteria for CUD 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
Exclusion criteria
- Triglycerides \> 500 mg/dL
- History of gall bladder disease
- Personal or family history of medullary thyroid carcinoma, or patients with a history of Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- History of diabetic retinopathy
- Being prescribed glucose-lowering medications
- An estimated glomerular filtration rate of less than 45 ml/min
- Lifetime history of taking semaglutide or other GLP-1 RAs
- Current suicidal ideation or suicide attempts within the past 24 months
- Present diagnosis of diabetes mellitus OR screening hemoglobin A1C \>/= 6.5
- Use of weight-lowering medications
- History of gastric bypass surgery
- History of myocardial infarction or stroke within the past 12 months
- Pregnant, breastfeeding, or the patient intends to become pregnant during the next four months
- Any contraindicated medical issues identified by the study investigators
- 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.
- Calcitonin value equal to or above 50 ng/L
- If completing the MRI portion of the study: claustrophobia or physical issues preventing MRI scan
- 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 it is running
2 locations listed across 2 US states.
- Institute of Human Virology at the University of Maryland School of Medicine - Washington D.C., District of Columbia, United States
- Institute of Human Virology at the University of Maryland School of Medicine - Baltimore, Maryland, United States