Clinical Trial

An Open-Label Tirzepatide Trial for Comorbid Obesity and Stimulant Use Disorder

Study acronym: TRI-MR
Not Yet Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
This open label pilot study will assess the feasibility and preliminary efficacy of tirzepatide which will be prescribed under its FDA approved weight management indication in adults with moderate or severe methamphetamine, cocaine or prescription stimulant use disorder (MUD) who also meet criteria for obesity or overweight with comorbidities. Up to 30 participants will receive 20 weeks of once weekly tirzepatide, followed by an observational follow up period. The study also incorporates MRI at seven time points to explore neural biomarkers associated with treatment response. All participants will receive 12 weeks of contingency management (CM) combined with cognitive behavioral therapy (CBT). Together, these pharmacologic, neuroimaging, and behavioral components will evaluate tirzepatide's potential to improve health and substance use outcomes in individuals with MUD.
Trial Details
NCT Number NCT07693608
Lead Sponsor University of Texas Southwestern Medical Center
Conditions Obesity, Methamphetamine Use Disorder, Cocaine Use Disorder, Stimulant Use Disorders
Enrollment 45 participants
Start Date 2026-08-01
Primary Completion 2030-02-01 (estimated)
Study Completion 2030-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-09