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ENROLLING BY INVITATION
NCT07693608
PHASE2

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

Sponsor: University of Texas Southwestern Medical Center

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.

Official title: An Open-Label Tirzepatide Trial for Comorbid Obesity and Stimulant Use Disorder Using fMRI to Identify Novel Neural Biomarkers

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2026-08-19

Completion Date

2030-03-01

Last Updated

2026-08-21

Healthy Volunteers

No

Interventions

DRUG

Tirzepatide

Following the instructions of the FDA-approved prescribing label, participants will receive the tirzepatide injection subcutaneously in either the abdomen, thigh, or upper arm once weekly for 20 weeks total. Following the instructions of the FDA-approved prescribing label, the dosing schedule will include a 4-week titration at a starting dosage of 2.5mg/week. After four weeks, dosage will be increased in 2.5mg increments, per prescribing label for tirzepatide. The recommended maintenance dosages per prescribing label are 5/mg/week, 10mg/week, or 15mg/week injected subcutaneously. Maximum dosage (up to 10mg/week) will be optimized for each individual. The 20-week treatment period will include initial 4-week of 2.5mg/week, followed by 16-week long once-weekly treatment with tirzepatide at a minimum dose of 5 mg/week (higher doses up to 10 mg/week as tolerated), that will be followed by an observational follow-up period every 4 weeks after week 20.

Locations (1)

UT Southwestern Medical Center

Dallas, Texas, United States