An Open-Label Tirzepatide Trial for Comorbid Obesity and Stimulant Use Disorder (NCT07693608) | Clinical Trial Compass
Not Yet RecruitingPhase 2
An Open-Label Tirzepatide Trial for Comorbid Obesity and Stimulant Use Disorder
United States45 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Be 18 to 65 years of age, inclusive.
. Be able to provide informed consent and ask relevant questions.
. Stated willingness to comply with all study procedures and availability for the duration of the study.
. Be willing to adhere to the study medication regimen
. Meet DSM-5 criteria for moderate or severe methamphetamine, cocaine or prescription stimulant use disorder.
. Self-report methamphetamine, cocaine or prescription stimulant use on 18 or more days in the 30-day period prior to written informed consent using the Timeline Followback (TLFB).
. Have an initial body mass index (BMI) at screening of:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effect of tirzepatide on self-reported use of stimulants
Timeframe: 32 weeks
Trial details
NCT IDNCT07693608
SponsorUniversity of Texas Southwestern Medical Center