T-STEM

RecruitingPhase 2

Randomized Controlled Trial of Tirzepatide for Methamphetamine Use Disorder

Lead sponsor

University of Texas Southwestern Medical Center

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Estimated enrollment

228

Study population

Alcohol / substance use

Eligibility highlights

•BMI ≥25

Primary endpoint

•Treatment response

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07825857

Org study IDSTU20260467

Timeline

Milestones

Study first posted2026-09-17actual

Study start2026-10-23actual

Last update posted2026-10-26actual

Primary completion2031-07-01estimated

Study completion2031-08estimated (month precision)

Assets

Investigational agents

Tirzepatide

Who this study enrolls

Alcohol / substance use

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•be aged 18 to 65 years;

•have moderate or severe methamphetamine use disorder;

•have active pattern of methamphetamine use;

•be interested in reducing or stopping methamphetamine use;

•be able and willing to provide informed consent, comply with all study procedures, and adhere to weekly study medication injections;

•be overweight or obese (body mass index ≥25 kg/m²); and

•(only for biological females) agree to use acceptable contraception and undergo urine pregnancy testing unless unable to become pregnant

Exclusion criteria

•report using any glucagon like peptide 1 receptor agonists (GLP-1RA, including tirzepatide), sulfonylureas, or insulin in the past 90 days;

•have a current eating disorder or severe alcohol or substance use disorder;

•have personal or family history of medullary thyroid carcinoma, history of multiple endocrine neoplasia type 2, or hypersensitivity, angioedema, or anaphylaxis to GLP-1RAs or tirzepatide;

•have Stage 3 or higher chronic kidney disease, inadequately controlled diabetes, history of diabetic retinopathy, any unstable or serious medical or psychiatric condition, or any other reason or clinical condition that may either interfere with study participation or make the study participation unsafe (per investigator judgement);

•are currently pregnant, breastfeeding, or planning pregnancy;

•have received an investigational drug within 30 days of informed consent;

•require psychiatric hospitalization;

•have recent suicidal or current homicidal ideation;

•are incarcerated or in court-mandated residential placement;

•have unsafe use of alcohol, benzodiazepines, sedative/hypnotics, or other substances; or

•have use of concurrent medications that may pose safety risks or interfere with study procedures.

Endpoints (7)

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 (unclassified)

Safety / tolerability / PK

Other clinical outcomes

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Tolerability - stopping of treatment

Time frame:26 weeks

descriptive

Secondary/protocol endpoint

Safety - occurrence of serious adverse event

Time frame:26 weeks

descriptive

Other clinical outcomes

2 endpoints

Secondary/protocol endpoint

Early remission

Time frame:27 weeks

descriptive

Secondary/protocol endpoint

Reduction in self-reported use of methamphetamine

Time frame:26 weeks

change from baseline, improvement

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

Treatment response

Time frame:26 weeks

descriptive

Secondary/protocol endpoint/low confidence

Current craving for methamphetamine

Time frame:27 weeks

descriptive

Secondary/protocol endpoint/low confidence

Worst past-week craving for methamphetamine

Time frame:27 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 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 November 5, 2026 snapshot.