Cocaine Use DisorderPhase 2STACNCT06691243
Evaluation Of Semaglutide in Adults With Cocaine Use Disorder With and Without HIV
A Phase 2 study testing Semaglutide in people with Cocaine Use Disorder and HIV, run by University of Maryland, Baltimore at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cocaine Use Disorder, HIV
- What is being tested?
- Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Aug 2025to Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Institute of Human Virology at the University of Maryland School of Medicine
Baltimore, Maryland, 21201
Institute of Human Virology at the University of Maryland School of Medicine
Washington D.C., District of Columbia, 20002
About this study
Official title: Evaluation Of Semaglutide Safety and Tolerability 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
Read the 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.
- Conditions
- Cocaine Use Disorder, HIV
- Being tested
- Semaglutide, Placebo
- Keywords
- semaglutide, GLP-1, cocaine use disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Also called Wegovy, Ozempic
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.
PlaceboDrug
Patients randomized to placebo arm will receive placebo injection every week.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Once weekly injection of semaglutide Receives: Drug: Semaglutide |
| Placebo | Placebo comparator | Once weekly injection of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of semaglutide in patients with cocaine use disorder (CUD) with and without HIV
Number of Grade 3 and 4 adverse effects reported by patients at any time after Day 0
Measured: 16 weeks
Tolerability of semaglutide in patients with cocaine use disorder (CUD) with and without HIV
Dose of semaglutide the patient tolerates regardless of the presence of adverse effects
Measured: 16 weeks
Secondary outcomes (20)
Determine if semaglutide improves cocaine use frequency in people with CUD with and without HIV
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.
Measured: 16 weeks
Determine if semaglutide reduces cocaine use in people with CUD with and without HIV
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.
Measured: 16 weeks
Determine if semaglutide reduces cocaine use in people with CUD with and without HIV
Change from baseline to highest tolerated semaglutide or placebo dose in presence of cocaine metabolite detected on urine drug-screen results.
Measured: 16 weeks
Determine if semaglutide reduces cocaine craving for people with CUD with and without HIV
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.
Measured: 16 weeks
Determine if semaglutide reduces drug use severity for people with CUD with and without HIV
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.
Measured: 16 weeks
Determine if semaglutide reduces risk taking behavior in people with cocaine use disorder, with and without HIV
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.
Measured: 16 weeks
Determine if semaglutide reduces impulsiveness in people with cocaine use disorder, with and without HIV
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.
Measured: 16 weeks
Determine if semaglutide reduces compulsivity in people with cocaine use disorder, with and without HIV
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.
Measured: 16 weeks
Determine if semaglutide impacts depression in people with cocaine use disorder, with and without HIV
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.
Measured: 16 weeks
Determine if semaglutide impacts anxiety in people with cocaine use disorder, with and without HIV
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.
Measured: 16 weeks
Determine if semaglutide impacts anhedonia in people with cocaine use disorder, with and without HIV
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
Measured: 16 weeks
Determine if semaglutide impacts sleep in people with cocaine use disorder, with and without HIV
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.
Measured: 16 weeks
Determine if semaglutide impacts sexual desire in people with cocaine use disorder, with and without HIV
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.
Measured: 16 weeks
Determine if semaglutide impacts food cravings in people with cocaine use disorder, with and without HIV
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.
Measured: 16 weeks
Determine if semaglutide changes levels of inflammatory biomarkers in patients with HIV relative to those without HIV
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
Measured: 16 weeks
Determine if semaglutide changes levels of clinically relevant cardiovascular biomarkers in patients with HIV relative to those without HIV
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
Measured: 16 weeks
Determine if semaglutide effects changes in body fat in individuals with cocaine use disorder, with and without HIV
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.
Measured: 16 weeks
Determine if semaglutide effects body fat distribution in people with CUD with and without HIV
Change from baseline to highest tolerated semaglutide or placebo dose in body fat distribution. The more central the body fat distribution, the worse outcomes.
Measured: 16 weeks
Determine if semaglutide effects changes muscle mass in patients with cocaine use disorder, with and without HIV
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.
Measured: 16 weeks
Determine if s.c. semaglutide produces changes in brain function in patients with cocaine use disorder, with and without HIV
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
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start7 Aug 2025
- Primary completionJan 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Sarah Kattakuzhy, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691243
- Sponsor's protocol ID
- HP-00112237
- Other IDs
- 75N90024C00036
- Acronym
- STAC
- Status last verified
- Sep 2026
- First submitted
- 6 Nov 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified IPD necessary to verify study results
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Semaglutide Safety and Tolerability in Adults With Cocaine Use Disorder With and Without HIV
- ClinicalTrials.gov ID
- NCT06691243
- Acronym / sponsor ID
- STAC / HP-00112237
- Conditions
- Cocaine Use Disorder, HIV
- Keywords
- semaglutide, GLP-1, cocaine use disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 15 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: SemaglutideOnce weekly injection of semaglutide |
| Placebo | Placebo comparator | Drug: PlaceboOnce weekly injection of placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideAlso: Wegovy, OzempicThe 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. | Drug | Semaglutide |
| PlaceboPatients randomized to placebo arm will receive placebo injection every week. | Drug | Placebo |
Primary outcome
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
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
20 secondary outcomes
Determine if semaglutide improves cocaine use frequency in people with CUD with and without HIV
Time frame: 16 weeks
Determine if semaglutide reduces cocaine use in people with CUD with and without HIV
Time frame: 16 weeks
Determine if semaglutide reduces cocaine use in people with CUD with and without HIV
Time frame: 16 weeks
Determine if semaglutide reduces cocaine craving for people with CUD with and without HIV
Time frame: 16 weeks
Determine if semaglutide reduces drug use severity for people with CUD with and without HIV
Time frame: 16 weeks
Determine if semaglutide reduces risk taking behavior in people with cocaine use disorder, with and without HIV
Time frame: 16 weeks
Determine if semaglutide reduces impulsiveness in people with cocaine use disorder, with and without HIV
Time frame: 16 weeks
Determine if semaglutide reduces compulsivity in people with cocaine use disorder, with and without HIV
Time frame: 16 weeks
Determine if semaglutide impacts depression in people with cocaine use disorder, with and without HIV
Time frame: 16 weeks
Determine if semaglutide impacts anxiety in people with cocaine use disorder, with and without HIV
Time frame: 16 weeks
Determine if semaglutide impacts anhedonia in people with cocaine use disorder, with and without HIV
Time frame: 16 weeks
Determine if semaglutide impacts sleep in people with cocaine use disorder, with and without HIV
Time frame: 16 weeks
Determine if semaglutide impacts sexual desire in people with cocaine use disorder, with and without HIV
Time frame: 16 weeks
Determine if semaglutide impacts food cravings in people with cocaine use disorder, with and without HIV
Time frame: 16 weeks
Determine if semaglutide changes levels of inflammatory biomarkers in patients with HIV relative to those without HIV
Time frame: 16 weeks
Determine if semaglutide changes levels of clinically relevant cardiovascular biomarkers in patients with HIV relative to those without HIV
Time frame: 16 weeks
Determine if semaglutide effects changes in body fat in individuals with cocaine use disorder, with and without HIV
Time frame: 16 weeks
Determine if semaglutide effects body fat distribution in people with CUD with and without HIV
Time frame: 16 weeks
Determine if semaglutide effects changes muscle mass in patients with cocaine use disorder, with and without HIV
Time frame: 16 weeks
Determine if s.c. semaglutide produces changes in brain function in patients with cocaine use disorder, with and without HIV
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Yes. All de-identified IPD necessary to verify study results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Semaglutide in people with Cocaine Use Disorder and HIV, run by University of Maryland, Baltimore at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of semaglutide in patients with cocaine use disorder (CUD) with and without HIV (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.