Recruiting
Phase 2

Semaglutide

Sponsor:

University of Maryland, Baltimore

Code:

NCT06691243

Conditions

Cocaine Use Disorder

HIV

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Semaglutide

Placebo

Study Details

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

Conditions

Cocaine Use Disorder

HIV

Study ID

NCT06691243

Start date

Aug 7, 2025

Status verified date

Aug, 2025

Completion date

Mar, 2027

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Semaglutide

Once weekly injection of semaglutide

placebo comparator: Placebo

Once weekly injection of placebo

Interventions

Semaglutide

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

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

Primary outcome measure

  • Safety of semaglutide in patients with cocaine use disorder (CUD) with and without HIV [ Time Frame: 16 weeks ]
  • Tolerability of semaglutide in patients with cocaine use disorder (CUD) with and without HIV [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Locations

Institute of Human Virology at the University of Maryland School of Medicine

Recruiting

Washington D.C., District of Columbia, United States, 20002

Contacts

Institute of Human Virology at the University of Maryland School of Medicine

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Onyinyechi Ogbumbadiugha-Weekes

443-635-4943oogbumbadiugha@ihv.umaryland.edu

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Aug 24, 2025

Last verified

Aug, 2025

Keywords

  • semaglutide
  • GLP-1
  • cocaine use disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2025-08-24.