DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT07227948

RecruitingPhase 2

Repurposing Semaglutide for the Treatment of Cocaine Use Disorder

Repurposing Semaglutide for the Treatment of Cocaine Use Disorder: a Pilot Mechanistic Study

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

75

estimated

Study population

Alcohol / substance use, Obesity / overweight

Key I/E criterion

•BMI ≥25

Primary endpoints

•Amplitude of the Late Positive Potential (LPP) in microvolts in response•Alcohol consumption, change•Cocaine craving

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07227948
Org study IDHSC-MS-25-0412
Secondary IDR01DA062720-01

Timeline

Milestones

Study first posted2025-11-13actual
Study start2026-01-15actual
Last update posted2026-03-19actual
Primary completion2029-01-28estimated
Study completion2029-02-28estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Alcohol / substance useObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•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 criteria

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.
•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.

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes
4
Other (unclassified)
1

Other clinical outcomes

4 endpoints
Primary/protocol endpoint/low confidence

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)

Alcohol consumption, change

change from baseline, improvement

Primary/protocol endpoint

Cocaine craving as assessed by the score on the Cocaine Cravings Questionnaire

Time frame:End of Treatment (Week 15)

change from baseline, improvement

Primary/protocol endpoint

Proportion of cocaine negative urine drug screens (UDS) during the final two weeks of treatment

Time frame:From Week 13 to Week 14

threshold achievement, improvement

Secondary/protocol endpoint

Treatment response as a dichotomous outcome during the last two weeks of treatment

Time frame:From Week 13 to Week 14

threshold achievement, improvement

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

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)

change from baseline, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.