Cocaine Use DisorderPhase 2NCT07227948
Repurposing Semaglutide for the Treatment of Cocaine Use Disorder
A Phase 2 study testing Semaglutide and cognitive behavioral therapy (CBT). in people with Cocaine Use Disorder, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), in combination with cognitive behavioral therapy (CBT) for the treatment of cocaine use disorder (CUD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cocaine Use Disorder
- What is being tested?
- Semaglutide and cognitive behavioral therapy (CBT).
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2026to 28 Feb 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Medical Exclusions
- 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.
Show all 32Show fewer
- 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.
- Psychiatric/Substance Use Exclusions
- 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.
- Weight-Related Exclusions
- Gained/lost ≥4.5 kg (10 lb.) over the past 6 months (prior to screening).
- Uncontrolled thyroid disease at screening
- Medication-Related Exclusions
- 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.
- General Exclusions
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Luba Yammine, PhD, 713-486-2737, Luba.Yammine@uth.tmc.edu
Jessica Vincent, (713) 486-2645, Jessica.N.Vincent@uth.tmc.edu
About this study
Official title: Repurposing Semaglutide for the Treatment of Cocaine Use Disorder: a Pilot Mechanistic Study
The purpose of this study is to evaluate semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), in combination with cognitive behavioral therapy (CBT) for the treatment of cocaine use disorder (CUD). This project is part of the NIH Helping to End Addiction Long-term (HEAL) initiative (https://heal.nih.gov/).
Read the detailed description
The United States is facing a resurgence in cocaine use and cocaine-related mortality. Despite the significant public health burden, there are no FDA-approved pharmacotherapies for CUD, and existing behavioral interventions, such as cognitive behavioral therapy (CBT), demonstrate only modest efficacy when used alone. Identifying pharmacological agents that can enhance the effectiveness of behavioral treatments remains a critical public health priority.
One particularly promising class of medications for CUD is glucagon-like peptide-1 receptor agonists (GLP-1RA). These agents are widely used to treat type 2 diabetes and obesity due to their ability to regulate blood glucose and support metabolic health. Importantly, GLP-1 receptors are expressed in brain regions involved in reward processing and hedonic behavior. Consistent with this, animal studies have shown that GLP-1RAs reduce the rewarding and reinforcing effects of various addictive substances, including cocaine. If similar effects are observed in humans, GLP-1RAs may improve treatment outcomes by directly reducing the motivational salience of cocaine and its cues, and/or by enhancing responsiveness to behavioral therapies such as CBT.
The primary objective of this trial is to provide proof-of-concept evidence for the use of a GLP-1RA semaglutide as a treatment for CUD. The study hypothesizes that semaglutide will modulate three key reward-related target mechanisms underlying cocaine use: (1) motivational relevance of cocaine cues, assessed via event-related potentials (ERPs); (2) cocaine valuation, measured by behavioral economic demand for cocaine; and (3) subjective experience of craving. These mechanisms will be evaluated using a multimodal approach - neurophysiological, behavioral, and self-report- within a framework of a randomized clinical trial. In addition to assessing changes in the proposed target mechanisms, the study will evaluate the impact of semaglutide on cocaine use.
This project addresses the urgent need to explore novel pharmacological targets using an experimental therapeutics framework and has the potential to accelerate the development of effective treatments for CUD. If successful, the findings will support a fully powered efficacy trial.
Study data will be submitted to a HEAL Initiative-approved repository within the HEAL Data Ecosystem (NIDA Data Share), in accordance with NIH and HEAL initiative data-sharing requirements. Persistent identifiers, seeded with essential project metadata, will be generated. These identifiers with associated project metadata will be made publicly available. The data will be available at the time of publication or at the end of the project period. The data submission and release timeframes will be specified by the funding agency and policies, as described on NIH's data sharing webpage. Study data will be available to the research community for the duration required by NIDA's retention policies.
- Conditions
- Cocaine Use Disorder
- Being tested
- Semaglutide, Placebo, cognitive behavioral therapy (CBT).
- Keywords
- semaglutide, GLP-1 agonist, cocaine addiction
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Participants will receive 14 weekly injections administered subcutaneously. Semaglutide will be initiated at a dose of 0.25 mg once weekly. After 4 weeks, the dose will be increased to 0.5 mg once weekly for an additional 4 weeks. Thereafter, the dose will be increased to 1 mg once weekly for 6 weeks
PlaceboDrug
Sterile saline (0.9%) will serve as the placebo for semaglutide and will be administered subcutaneously once-weekly for 14 weeks. The placebo will be administered in the same blinded manner as semaglutide and will be volume-matched.
cognitive behavioral therapy (CBT).Behavioural
Participants will receive fourteen weekly 1-hour sessions of individual cognitive behavioral therapy (CBT), an evidence-based behavioral therapy platform for evaluating pharmacotherapy for CUD. CBT focuses on (1) identifying situations that precipitate drug use and (2) preventing relapse by teaching cognitive and behavioral skills to reduce risk.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Not described Receives: Drug: Semaglutide; Behavioral: cognitive behavioral therapy (CBT). |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo; Behavioral: cognitive behavioral therapy (CBT). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of the Late Positive Potential (LPP) in microvolts in response to visual stimuli on the Picture Viewing Task.
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.
Measured: End of Treatment (Week 15)
Intensity of demand as assessed by the amount of cocaine purchased and consumed as assessed by cocaine purchasing task
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.
Measured: End of Treatment (Week 15)
Cocaine craving as assessed by the score on the Cocaine Cravings Questionnaire
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.
Measured: End of Treatment (Week 15)
Proportion of cocaine negative urine drug screens (UDS) during the final two weeks of treatment
Use of cocaine at the end of treatment
Measured: From Week 13 to Week 14
Secondary outcomes (1)
Treatment response as a dichotomous outcome during the last two weeks of treatment
Defined as at least three cocaine-negative urine drug screens (UDS) during the last two weeks of treatment
Measured: From Week 13 to Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2025
- Study start15 Jan 2026
- Primary completion28 Jan 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- 75 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Luba Yammine, The University of Texas Health Science Center, Houston
- Investigators
- Luba Yammine, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227948
- Sponsor's protocol ID
- HSC-MS-25-0412
- Other IDs
- R01DA062720-01
- Status last verified
- Mar 2026
- First submitted
- 10 Nov 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yammine L, Versace F, Green CE, Webber HE, Yoon JH, Gutierrez AD, Leonard SJ, Weaver MF, Schmitz J. Repurposing semaglutide as an adjunctive treatment for cocaine use disorder: protocol for a randomised controlled trial. BMJ Open. 2026 May 20;16(5):e115675. doi: 10.1136/bmjopen-2025-115675.
PubMed 42161545
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repurposing Semaglutide for the Treatment of Cocaine Use Disorder: a Pilot Mechanistic Study
- ClinicalTrials.gov ID
- NCT07227948
- Acronym / sponsor ID
- HSC-MS-25-0412
- Conditions
- Cocaine Use Disorder
- Keywords
- semaglutide, GLP-1 agonist, cocaine addiction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 28 Jan 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 13 Nov 2025 (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 study is to evaluate semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), in combination with cognitive behavioral therapy (CBT) for the treatment of cocaine use disorder (CUD). This project is part of the NIH Helping to End Addiction Long-term (HEAL) initiative (https://heal.nih.gov/).
Detailed description
The United States is facing a resurgence in cocaine use and cocaine-related mortality. Despite the significant public health burden, there are no FDA-approved pharmacotherapies for CUD, and existing behavioral interventions, such as cognitive behavioral therapy (CBT), demonstrate only modest efficacy when used alone. Identifying pharmacological agents that can enhance the effectiveness of behavioral treatments remains a critical public health priority.
One particularly promising class of medications for CUD is glucagon-like peptide-1 receptor agonists (GLP-1RA). These agents are widely used to treat type 2 diabetes and obesity due to their ability to regulate blood glucose and support metabolic health. Importantly, GLP-1 receptors are expressed in brain regions involved in reward processing and hedonic behavior. Consistent with this, animal studies have shown that GLP-1RAs reduce the rewarding and reinforcing effects of various addictive substances, including cocaine. If similar effects are observed in humans, GLP-1RAs may improve treatment outcomes by directly reducing the motivational salience of cocaine and its cues, and/or by enhancing responsiveness to behavioral therapies such as CBT.
The primary objective of this trial is to provide proof-of-concept evidence for the use of a GLP-1RA semaglutide as a treatment for CUD. The study hypothesizes that semaglutide will modulate three key reward-related target mechanisms underlying cocaine use: (1) motivational relevance of cocaine cues, assessed via event-related potentials (ERPs); (2) cocaine valuation, measured by behavioral economic demand for cocaine; and (3) subjective experience of craving. These mechanisms will be evaluated using a multimodal approach - neurophysiological, behavioral, and self-report- within a framework of a randomized clinical trial. In addition to assessing changes in the proposed target mechanisms, the study will evaluate the impact of semaglutide on cocaine use.
This project addresses the urgent need to explore novel pharmacological targets using an experimental therapeutics framework and has the potential to accelerate the development of effective treatments for CUD. If successful, the findings will support a fully powered efficacy trial.
Study data will be submitted to a HEAL Initiative-approved repository within the HEAL Data Ecosystem (NIDA Data Share), in accordance with NIH and HEAL initiative data-sharing requirements. Persistent identifiers, seeded with essential project metadata, will be generated. These identifiers with associated project metadata will be made publicly available. The data will be available at the time of publication or at the end of the project period. The data submission and release timeframes will be specified by the funding agency and policies, as described on NIH's data sharing webpage. Study data will be available to the research community for the duration required by NIDA's retention policies.
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: Semaglutide, Behavioral: cognitive behavioral therapy (CBT). |
| Placebo | Placebo comparator | Drug: Placebo, Behavioral: cognitive behavioral therapy (CBT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (32 listed)
- Medical Exclusions
- 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).
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 |
|---|---|---|
| SemaglutideParticipants will receive 14 weekly injections administered subcutaneously. Semaglutide will be initiated at a dose of 0.25 mg once weekly. After 4 weeks, the dose will be increased to 0.5 mg once weekly for an additional 4 weeks. Thereafter, the dose will be increased to 1 mg once weekly for 6 weeks | Drug | Semaglutide |
| PlaceboSterile saline (0.9%) will serve as the placebo for semaglutide and will be administered subcutaneously once-weekly for 14 weeks. The placebo will be administered in the same blinded manner as semaglutide and will be volume-matched. | Drug | Placebo |
| cognitive behavioral therapy (CBT).Participants will receive fourteen weekly 1-hour sessions of individual cognitive behavioral therapy (CBT), an evidence-based behavioral therapy platform for evaluating pharmacotherapy for CUD. CBT focuses on (1) identifying situations that precipitate drug use and (2) preventing relapse by teaching cognitive and behavioral skills to reduce risk. | Behavioural | Placebo, Semaglutide |
Primary outcome
Amplitude of the Late Positive Potential (LPP) in microvolts in response to visual stimuli on the Picture Viewing Task.
Time frame: 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 task
Time frame: End 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 Questionnaire
Time frame: End 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 treatment
Time frame: From Week 13 to Week 14
Use of cocaine at the end of treatment
1 secondary outcome
Treatment response as a dichotomous outcome during the last two weeks of treatment
Time frame: From Week 13 to Week 14
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 19 Mar 2026.
- Derived from this study: PubMed 42161545Yammine L, Versace F, Green CE, Webber HE, Yoon JH, Gutierrez AD, Leonard SJ, Weaver MF, Schmitz J. Repurposing semaglutide as an adjunctive treatment for cocaine use disorder: protocol for a randomised controlled trial. BMJ Open. 2026 May 20;16(5):e115675. doi: 10.1136/bmjopen-2025-115675.
- Individual participant dataSharing planned: No
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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.
Luba Yammine, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site 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 and cognitive behavioral therapy (CBT). in people with Cocaine Use Disorder, run by The University of Texas Health Science Center, Houston at 1 site 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 32 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: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Luba Yammine, PhD ((713) 486-2737, Luba.Yammine@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amplitude of the Late Positive Potential (LPP) in microvolts in response to visual stimuli on the Picture Viewing Task. (time frame: End of Treatment (Week 15)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07227948, which also lists 1 linked publication.
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 19 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.