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Randomized Controlled Trial of Tirzepatide for Methamphetamine Use Disorder
Sponsor: University of Texas Southwestern Medical Center
Summary
This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group trial evaluating the tolerability, safety, and preliminary efficacy of tirzepatide for the treatment of individuals with moderate or severe methamphetamine use disorder (MtUD). The central hypothesis of the proposed research is that tirzepatide is a safe and potentially efficacious treatment of MtUD. Participants will undergo study procedures over 32 weeks, including: 1. completing self-assessments 2. undergo brief physical and review of medical and psychiatric history 3. provide urine and blood samples 4. medical management sessions 5. weekly subcutaneous study medication injections
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
228
Start Date
2026-10-01
Completion Date
2031-08
Last Updated
2026-09-23
Healthy Volunteers
No
Conditions
Interventions
Tirzepatide
Eligible participants who are randomized to treatment group will receive once-weekly subcutaneous injections of tirzepatide for a 26-week period. Tirzepatide will start at 2.5 mg/week with planned dose increases every four weeks in 2.5 mg/week increments up to a maximum of 15 mg/week (or the maximally tolerated dose).
Placebo (saline)
Eligible participants who are randomized to placebo group will receive once-weekly subcutaneous injections of saline for a 26-week period.
Locations (4)
University of Southern California (USC)
Los Angeles, California, United States
Center of Substance Use and Health
San Francisco, California, United States
Oklahoma State University (OSU) Center for Health Services
Tulsa, Oklahoma, United States
UT Southwestern Medical Center
Dallas, Texas, United States