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Randomized Controlled Trial of Tirzepatide for Methamphetamine Use Disorder

Study acronym: T-STEM
StatusNot Yet Recruiting
PhasePhase 2
Started2026-10-01
View on ClinicalTrials.gov ↗
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
Trial Details
NCT Number NCT07825857
Lead Sponsor University of Texas Southwestern Medical Center
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions Methamphetamine Use Disorder
Enrollment 228 participants
Start Date 2026-10-01
Primary Completion 2031-07-01 (estimated)
Study Completion 2031-08 (estimated)
Updated on ClinicalTrials.gov 2026-09-23