Tirzepatide for methamphetamine use disorder (phase 2)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In a randomized, double-blind design, adults with methamphetamine use disorder are assigned to tirzepatide or placebo for 26 weeks, with a 6-week follow-up. The study measures safety and tolerability, changes in methamphetamine use via urine tests and self-reports, and whether participants achieve early remission. Secondary aims look at cravings for methamphetamine and other substances. Participants complete weekly injections and regular assessments over a 32-week period.

Why it matters

Who can join: the full rules

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.

Where it's running

• UT Southwestern Medical Center
  Dallas, Texas, United States Recruiting
• University of Southern California (USC)
  Los Angeles, California, United States Not yet recruiting
• Center of Substance Use and Health
  San Francisco, California, United States Not yet recruiting
• Oklahoma State University (OSU) Center for Health Services
  Tulsa, Oklahoma, United States Not yet recruiting

Study contacts

• Principal investigator: Manish Jha, MBBS — University of Texas Southwestern Medical Center
• Study coordinator: Elizabeth Dedrick, BS
• Email: elizabeth.dedrick@utsouthwestern.edu
• Phone: 469-602-2356

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• CHAMPION: Combining HIV Prevention and Meth Treatment for HIV-Negative MSM

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• Methamphetamine cue-reactivity and cognitive reappraisal in men with methamphetamine use disorder

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• Troriluzole and methamphetamine response

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.