Clinical trial NCT06691243: Evaluation Of Semaglutide in Adults With Cocaine Use Disorder With and Without HIV
Official title: Evaluation Of Semaglutide Safety and Tolerability in Adults With Cocaine Use Disorder With and Without HIV
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Cocaine Use Disorder
HIV
Keywords: semaglutide
GLP-1
cocaine use disorder
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2024-11-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: STAC is a 16-week, double-blind, placebo-controlled, pilot, dose-escalation study that aims to determine the dose of semaglutide that is safe and tolerable in individuals with cocaine use disorder, including those with and without HIV; whether semaglutide improves drug use outcomes for cocaine use; and whether semaglutide improves cardiac and inflammatory biomarkers. Interested participants will be consented and screened, and after screening process is completed, all eligible participants who desire to continue with the study will be randomized either to semaglutide injections or placebo injections. Participants will receive semaglutide or placebo injections once a week from Day 0 through Week 16, and a final assessment will be completed at Week 16. Study visits will also intermittently complete labwork, medical examinations, clinical assessments and surveys.

Participants who consent to the optional MRI visits, will also complete MRI's at two timepoints: once before starting the study medication and once near Week 16.

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

Primary outcomes:
measure: Safety of semaglutide in patients with cocaine use disorder (CUD) with and without HIV
timeFrame: 16 weeks
measure: Tolerability of semaglutide in patients with cocaine use disorder (CUD) with and without HIV
timeFrame: 16 weeks
Secondary outcomes:
measure: Determine if semaglutide improves cocaine use frequency in people with CUD with and without HIV
timeFrame: 16 weeks
measure: Determine if semaglutide reduces cocaine use in people with CUD with and without HIV
timeFrame: 16 weeks
measure: Determine if semaglutide reduces cocaine use in people with CUD with and without HIV
timeFrame: 16 weeks
measure: Determine if semaglutide reduces cocaine craving for people with CUD with and without HIV
timeFrame: 16 weeks
measure: Determine if semaglutide reduces drug use severity for people with CUD with and without HIV
timeFrame: 16 weeks
measure: Determine if semaglutide reduces risk taking behavior in people with cocaine use disorder, with and without HIV
timeFrame: 16 weeks
measure: Determine if semaglutide reduces impulsiveness in people with cocaine use disorder, with and without HIV
timeFrame: 16 weeks
measure: Determine if semaglutide reduces compulsivity in people with cocaine use disorder, with and without HIV
timeFrame: 16 weeks
measure: Determine if semaglutide impacts depression in people with cocaine use disorder, with and without HIV
timeFrame: 16 weeks
measure: Determine if semaglutide impacts anxiety in people with cocaine use disorder, with and without HIV
timeFrame: 16 weeks
measure: Determine if semaglutide impacts anhedonia in people with cocaine use disorder, with and without HIV
timeFrame: 16 weeks
measure: Determine if semaglutide impacts sleep in people with cocaine use disorder, with and without HIV
timeFrame: 16 weeks
measure: Determine if semaglutide impacts sexual desire in people with cocaine use disorder, with and without HIV
timeFrame: 16 weeks
measure: Determine if semaglutide impacts food cravings in people with cocaine use disorder, with and without HIV
timeFrame: 16 weeks
measure: Determine if semaglutide changes levels of inflammatory biomarkers in patients with HIV relative to those without HIV
timeFrame: 16 weeks
measure: Determine if semaglutide changes levels of clinically relevant cardiovascular biomarkers in patients with HIV relative to those without HIV
timeFrame: 16 weeks
measure: Determine if semaglutide effects changes in body fat in individuals with cocaine use disorder, with and without HIV
timeFrame: 16 weeks
measure: Determine if semaglutide effects body fat distribution in people with CUD with and without HIV
timeFrame: 16 weeks
measure: Determine if semaglutide effects changes muscle mass in patients with cocaine use disorder, with and without HIV
timeFrame: 16 weeks
measure: Determine if s.c. semaglutide produces changes in brain function in patients with cocaine use disorder, with and without HIV
timeFrame: 16 weeks
Other outcomes:
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