Randomized Controlled Trial of Tirzepatide for Methamphetamine Use Disorder
- Status
- Not yet recruitingResults none
- Why it is watched
- population of special interest (non-obese / healthy / non-diabetic)
- Who it enrolls
- age 18 Years to 65 Years; excludes diabetes; no BMI minimum stated; conditions: Methamphetamine Use Disorder
- Interventions
- Tirzepatide; Placebo (saline)
- Conditions
- Methamphetamine Use Disorder
- Phase and size
- Phase 2 · 228 participants
- Dates
- Start 2026-10-01
Primary completion 2031-07-01 - Sponsor
- University of Texas Southwestern Medical Center (Other)
- Last checked
- Sep 20, 2026
01Endpoints
What the trial will measure
- Treatment response26 weeks
02Eligibility
Who can take part
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.
03Change log
Registry changes
No changes recorded since the trial was added.