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Semaglutide for Cocaine Use Disorder

This study is looking at whether semaglutide, a medication already used for diabetes and weight loss, can help people with cocaine use disorder (CUD). Participants will receive either semaglutide or a placebo (an inactive substance) through weekly injections for 14 weeks. Everyone in the study will also receive 14 weekly sessions of cognitive behavioral therapy (CBT), a type of talk therapy. The researchers want to see if semaglutide, when combined with CBT, can reduce cocaine cravings and use. You may be able to join if you are 18 or older, have a diagnosis of CUD, and have recently used cocaine. The study aims to enroll 75 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It will involve 75 participants who will be randomly assigned to receive either semaglutide or a placebo, along with cognitive behavioral therapy.
What's involved
You would receive 14 weekly injections of either semaglutide or a placebo, and attend 14 weekly one-hour sessions of individual cognitive behavioral therapy.
Compensation
Not stated in the trial record.
Follow-up
The main measurements for the study are taken at the end of treatment (Week 15).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07227948

Repurposing Semaglutide for the Treatment of Cocaine Use Disorder

Recruiting
PHASE2Ages 18+InterventionalTreatment
The University of Texas Health Science Center, Houston
~75 participants
Updated 2026-03-19 on ClinicalTrials.gov
What's tested:SemaglutidePlacebocognitive behavioral therapy (CBT).

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Amplitude of the Late Positive Potential (LPP) in microvolts in response to visual stimuli on the Picture Viewing Task.
Measured over End of Treatment (Week 15)
+3 more outcomes measured

Conditions

Cocaine Use Disorder

Explore related trials

Cocaine Use Disorder

NCT07227948

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • The University of Texas Health Science Center at Houston

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Luba Yammine, PhD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

Who to contact

Luba Yammine, PhD
[email protected]
(713) 486-2737
Email the study team

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Eligibility criteria

Inclusion

Ability to provide informed consent before any study-related activity, willing to comply with all study procedures, and be available for the duration of the study.
Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) diagnostic criteria for CUD and report recent cocaine use (verified by at least one positive urine drug screen (UDS) for the cocaine metabolite benzoylecgonine (BE), during intake).
Have body mass index (BMI) of ≥25 kg/m2
Agree (if the participant is female and of child-bearing potential) to use effective contraceptive methods, unless the participant's male partner(s) is surgically sterile (underwent vasectomy). Acceptable contraceptives include oral contraceptives, contraceptive sponge, patch, double barrier (diaphragm/spermicidal or condom/spermicidal), intrauterine contraceptive system, etonogestrel implant, medroxyprogesterone acetate contraceptive injection, complete abstinence from sexual intercourse, and/or hormonal vaginal ring. Contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use. Women of child-bearing potential must provide negative urine pregnancy test prior to randomization. Note: A woman is considered fertile (of childbearing potential) following menarche and until becoming postmenopausal unless permanently sterile. Women in the following categories are not considered a woman of childbearing potential: premenarcheal, premenopausal female with one of the following: documented hysterectomy, documented bilateral salpingectomy, documented bilateral oophorectomy. Postmenopausal female is defined as no menses for 12 months without an alternative medical cause. Females on HRT and whose menopausal status is in doubt will be required to use one of the nonhormonal highly effective contraception methods if they wish to continue their hormone replacement therapy (HRT) during the trial.
Have a medical and psychiatric history and a brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the Study Physician and the Principal Investigator.
Be able to provide the names of at least 2 persons who can consistently locate their whereabouts.

Exclusion

Personal or first-degree relative(s) history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).
History or presence of chronic pancreatitis or recent acute pancreatitis.
Type 1 or type 2 diabetes mellitus (previously diagnosed or indicated by HbA1C ≥48 mol/mol (6.5%) as measured at screening).
Severe gastrointestinal disease (i.e., severe gastroparesis).
History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.
History of severe cardiovascular disease.
History of retinopathy.
Systolic blood pressure (SBP) \>180 mmHg and/or diastolic blood pressure (DBP) \>105 mmHg)
End stage renal disease (ESRD, previously diagnosed or indicated by estimated glomerular filtration rate (eGFR) value of eGFR \< 15 ml/min/1.73 m2 at screening).
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 times the upper limit of normal range at screening.
Known or suspected hypersensitivity to semaglutide, excipients, or related products.
History of seizure or elevated risk of seizure.
Women who are currently pregnant, or plan to become pregnant, or lactating, or of childbearing potential and are not using medically accepted forms of contraception
Have any medical illness or condition which in the opinion of the PI and/or the Study Physician would preclude safe and/or successful completion of the study.
Any foreseeable procedure requiring general anesthesia or deep sedation.
Current ≥ moderate substance use disorder aside from alcohol, nicotine, or marijuana, or a Substance Use Disorder (SUD) requiring medical detoxification (e.g., alcohol, opioid, benzodiazepine)
Current or recent suicidal ideation.
Homicidal ideation that requires immediate attention.
Have any psychiatric illness or condition which in the opinion of the PI and/or the Study Physician would preclude safe and/or successful completion of the study.
Gained/lost ≥4.5 kg (10 lb.) over the past 6 months (prior to screening).
Uncontrolled thyroid disease at screening
Currently using sincalide, sulfonylureas, insulin and insulin products, or medication used for weight management (i.e., orlistat, naltrexone-bupropion, liraglutide, semaglutide, tirzepatide, phentermine, topiramate, benzphetamine, diethylpropion, phendimetrazine).
Any otherwise not specified concomitant medication that could compromise participant safety or treatment in the opinion of the Study Physician and/or the PIs.
Current, anticipated, or pending enrollment in another addiction treatment program and/or research study that could potentially affect participant safety and/or the study data/design as determined by the Principal Investigator and/or Study Physician.
Not planning to live in the area for the duration of the trial.
Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the PI and/or the Study Physician.
Unable to communicate (read, write, and speak) fluently in English.

What this trial measures

  • Amplitude of the Late Positive Potential (LPP) in microvolts in response to visual stimuli on the Picture Viewing Task.End of Treatment (Week 15)

    EEG will be recorded during a passive picture viewing presentation that will include cocaine-related, neutral, and nondrug-related pleasant and unpleasant images. For each participant, the amplitude of the LPP component will be calculated separately for each picture category and used to evaluate the motivational relevance of the images.LPP amplitude reflects the motivational relevance of visual stimuli, with larger amplitudes indicating greater motivational salience.

  • Intensity of demand as assessed by the amount of cocaine purchased and consumed as assessed by cocaine purchasing taskEnd of Treatment (Week 15)

    Participants will complete the hypothetical Cocaine Purchasing Task, in which they report the amount of cocaine they would purchase and use at escalating price levels. Demand curve metrics (Intensity, Omax, Pmax, and Elasticity) will be calculated to quantify the relative reinforcing value and motivation to obtain cocaine. Lower demand values indicate reduced motivation for cocaine.

  • Cocaine craving as assessed by the score on the Cocaine Cravings QuestionnaireEnd of Treatment (Week 15)

    Cocaine craving will be assessed using a 10-item self-report questionnaire. Each item is rated on a 5-point Likert scale from 1 = Strongly Disagree to 5 = Strongly Agree. The total craving score is calculated as the mean of all item responses, with higher scores indicating greater craving intensity.

  • Proportion of cocaine negative urine drug screens (UDS) during the final two weeks of treatmentFrom Week 13 to Week 14

    Use of cocaine at the end of treatment