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

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Nov 13, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called semaglutide to see if it's safe and effective for adults struggling with cocaine use disorder (CUD), both with and without HIV. If you are an adult aged 18 or older who has been using cocaine frequently, you might be eligible to participate. To qualify, you should have a body mass index (BMI) between 20 and 50, and if you're of childbearing age, you will need to agree to use birth control.

Participants in the trial will receive either semaglutide or a placebo (a harmless substance with no active medication) through weekly injections at the clinic. Additionally, you'll visit the clinic every two weeks for lab tests and assessments. This study is currently not recruiting participants, but it’s important to know that it’s designed to help researchers understand more about treating cocaine use disorder and potentially improve care for those affected by it.

Gender

ALL

Eligibility 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