Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06691243

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cocaine Use Disorder HIV

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institute of Human Virology at the University of Maryland School of Medicine, Washington D.C., District of Columbia, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Wegovy, Ozempic

Placebo

Drug

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

Primary outcomes

  1. Safety of semaglutide in patients with cocaine use disorder (CUD) with and without HIV

    Time frame: 16 weeks

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

  2. Tolerability of semaglutide in patients with cocaine use disorder (CUD) with and without HIV

    Time frame: 16 weeks

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

Secondary outcomes

  1. Determine if semaglutide improves cocaine use frequency in people with CUD with and without HIV

    Time frame: 16 weeks

    Change from baseline to highest tolerated semaglutide or placebo dose in cocaine use frequency via timeline followback method. The higher the frequency of cocaine use, the worse the outcome.

  2. Determine if semaglutide reduces cocaine use in people with CUD with and without HIV

    Time frame: 16 weeks

    Change from baseline to highest tolerated semaglutide or placebo dose of mean dollar-amount patients spent on cocaine during the past 7 days. The higher the amount, the worse the outcome.

  3. Determine if semaglutide reduces cocaine use in people with CUD with and without HIV

    Time frame: 16 weeks

    Change from baseline to highest tolerated semaglutide or placebo dose in presence of cocaine metabolite detected on urine drug-screen results.

  4. Determine if semaglutide reduces cocaine craving for people with CUD with and without HIV

    Time frame: 16 weeks

    Change from baseline to highest tolerated semaglutide or placebo dose in score on Cocaine Craving Questionnaire Brief (CCQ-Brief). Minimum score= 8 (minimal craving). Maximum score= 56 (extreme craving). The higher the score, the worse the outcome.

  5. Determine if semaglutide reduces drug use severity for people with CUD with and without HIV

    Time frame: 16 weeks

    Change from baseline to highest tolerated semaglutide or placebo dose in score on the Drug Abuse Screening Test (DAST). Minimum Value= 0 (No problems with drug abuse or dependence. Maximum Value= 10 ( severe drug-related problems). The higher the score, the worse the outcome.

  6. Determine if semaglutide reduces risk taking behavior in people with cocaine use disorder, with and without HIV

    Time frame: 16 weeks

    Change from baseline to highest tolerated semaglutide or placebo dose in score on Balloon Analogue Risk Task (BART). Minimum score= 0 (no risk taking). Maximum: Variable, it can go up to 500-1000. Higher Scores= Higher risk taking behavior.

  7. Determine if semaglutide reduces impulsiveness in people with cocaine use disorder, with and without HIV

    Time frame: 16 weeks

    Change from baseline to highest tolerated semaglutide or placebo dose in score on Barratt Impulsiveness Scale (BAS-11) Minimum score: 30, Maximum score: 120. Higher score equals high impulsivity.

  8. Determine if semaglutide reduces compulsivity in people with cocaine use disorder, with and without HIV

    Time frame: 16 weeks

    Change from baseline to highest tolerated semaglutide or placebo dose in score on Obsessive-Compulsive Cocaine Use Scale. Minimum score: 0 (no symptoms), Maximum Score: 32. Higher score = greater severity of obsessive-compulsive symptoms related to cocaine use. The higher the score, the worse the outcome.

  9. Determine if semaglutide impacts depression in people with cocaine use disorder, with and without HIV

    Time frame: 16 weeks

    Change from baseline to highest tolerated semaglutide or placebo dose in score on Patient Health Questionnaire-9 (PHQ-9). Minimum score: 0 (no depressive symptoms). Maximum score: 27 (severe depression). Higher score indicates worse outcome.

  10. Determine if semaglutide impacts anxiety in people with cocaine use disorder, with and without HIV

    Time frame: 16 weeks

    Change from baseline to highest tolerated semaglutide or placebo dose in score on Generalized Anxiety Disorder-7 (GAD-7). Minimum score= 0 (no anxiety symptoms). Maximum= 21 (severe anxiety) Higher score indicates worse outcome.

  11. Determine if semaglutide impacts anhedonia in people with cocaine use disorder, with and without HIV

    Time frame: 16 weeks

    Change from baseline to highest tolerated semaglutide or placebo dose in score on Snaith-Hamilton Pleasure Scale (SHAPS). Minimum score=0 (no anhedonia). Maximum score=14 (severe anhedonia). The higher the score, the worse the outcome

  12. Determine if semaglutide impacts sleep in people with cocaine use disorder, with and without HIV

    Time frame: 16 weeks

    Change from baseline to highest tolerated semaglutide or placebo dose in score on Pittsburgh Sleep Quality Index (PSQI). Minimum score= 0 (good sleep quality). Maximum= 21 (poor sleep quality). The higher the score, the worse the outcome.

  13. Determine if semaglutide impacts sexual desire in people with cocaine use disorder, with and without HIV

    Time frame: 16 weeks

    Change from baseline to highest tolerated semaglutide or placebo dose in score on the Sexual Desire Inventory (SDI).- Minimum score= 0 (no sexual desire). Maximum score= 60 (high sexual desire). The lower the score, the worse the outcome.

  14. Determine if semaglutide impacts food cravings in people with cocaine use disorder, with and without HIV

    Time frame: 16 weeks

    Change from baseline to highest tolerated semaglutide or placebo dose in score on the General Trait Food Cravings Questionnaire (G-FCQ-T). Minimum score = 0 (no food cravings). Maximum score =7 (high frequency and intensity of cravings). The lower the score, the worse the outcome.

  15. Determine if semaglutide changes levels of inflammatory biomarkers in patients with HIV relative to those without HIV

    Time frame: 16 weeks

    Levels of HIV-induced inflammation markers (inflammatory cytokines, IFN-g, TNF, IL-6, IL-8, chemokine, IL18, CD163, Neopterin, beta 2 microglobulin, LPS, sCD14, sCD25, IL12, IL10) before and after s.c. semaglutide

  16. Determine if semaglutide changes levels of clinically relevant cardiovascular biomarkers in patients with HIV relative to those without HIV

    Time frame: 16 weeks

    Levels of cardiovascular biomarkers (levels of high-sensitivity C-reactive protein (CRP), high-sensitivity troponin (hs- hs-TRP), endothelin-1 (ET-1), D-dimer before and after s.c. semaglutide

  17. Determine if semaglutide effects changes in body fat in individuals with cocaine use disorder, with and without HIV

    Time frame: 16 weeks

    Change from baseline to highest tolerated semaglutide or placebo dose in percent body fat using the InBody scan. The lower the percent body fat, the worse the outcome.

  18. Determine if semaglutide effects body fat distribution in people with CUD with and without HIV

    Time frame: 16 weeks

    Change from baseline to highest tolerated semaglutide or placebo dose in body fat distribution. The more central the body fat distribution, the worse outcomes.

  19. Determine if semaglutide effects changes muscle mass in patients with cocaine use disorder, with and without HIV

    Time frame: 16 weeks

    Change from baseline to highest tolerated semaglutide or placebo dose in percent muscle mass using the InBody Scan. The lower the percentage of muscle mass, the worse the outcome.

  20. Determine if s.c. semaglutide produces changes in brain function in patients with cocaine use disorder, with and without HIV

    Time frame: 16 weeks

    Magnetic Resonance Spectroscopy (MRS)will be used to assess whether s.c. semaglutide produces changes in brain metabolite levels; Resting state functional connectivity (RSFC) will be used to assess whether s.c. semaglutide produces changes in brain network function; An Arterial Spin Labeling (ASL) sequence that measures Blood Brain Barrier (BBB) permeability will be used to assess whether s.c. semaglutide produces changes in BBB integrity

Study contacts

Contact information is provided by the study sponsor or research team.

Onyinyechi Ogbumbadiugha-Weekes

CONTACT

[email protected]

443-635-4943

Sarah Kattakuzhy

CONTACT

[email protected]

443-691-4638

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: STAC

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 15, 2024
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.