Clinical trial

Evaluation Of Semaglutide in Adults With Cocaine Use Disorder With and Without HIV

Recruiting now · Phase 2 · 1 countries · Registry ID NCT06691243

Recruiting nowPhase 2Interventional

What this study 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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionCocaine Use Disorder, HIV

Full registry criteria

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

Treatments and study arms

Semaglutide

Drug

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.

Placebo

Drug

Patients randomized to placebo arm will receive placebo injection every week.

Primary outcomes

Safety of semaglutide in patients with cocaine use disorder (CUD) with and without HIV16 weeks

Number of Grade 3 and 4 adverse effects reported by patients at any time after Day 0

Tolerability of semaglutide in patients with cocaine use disorder (CUD) with and without HIV16 weeks

Dose of semaglutide the patient tolerates regardless of the presence of adverse effects

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Institute of Human Virology at the University of Maryland School of Medicine🇺🇸 Baltimore, Maryland, United States
Onyinyechi Ogbumbadiugha-WeekesContact
Institute of Human Virology at the University of Maryland School of Medicine🇺🇸 Washington D.C., District of Columbia, United States
Emade EbahContact