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

NCT07693608 · Not yet recruiting

Last updated 2026-07-13

This clinical trial is testing the medication tirzepatide in adults who have both obesity and a stimulant use disorder, such as methamphetamine or cocaine use disorder, to see how it affects their stimulant use.

Status Not yet recruiting Approved but enrollment has not started.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design open-label (no blinding) treatment study

Participants 45 people Planned (estimated).

Who can join Ages 18–65 · all sexes

Timeline Started 2026-08 · est. completion 2030-03

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT07693608 ↗

Description as written by the study sponsor.

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.

Treatments tested

Tirzepatide Drug

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.

Main thing measured	Effect of tirzepatide on self-reported use of stimulants
Sponsor	University of Texas Southwestern Medical Center
Conditions studied	Obesity, Methamphetamine Use Disorder, Cocaine Use Disorder, Stimulant Use Disorders
GLP-1 drugs	tirzepatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07693608 ↗