Tirzepatide for Methamphetamine Addiction
(T-STEM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests tirzepatide, a medication, to determine its effectiveness in helping people with moderate or severe methamphetamine addiction. Researchers aim to assess its safety and efficacy in reducing methamphetamine use. Participants will receive weekly injections and undergo various assessments over 32 weeks. The trial seeks individuals with an active pattern of methamphetamine use who are interested in quitting or reducing their use and are overweight or obese. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Is there any evidence suggesting that tirzepatide is likely to be safe for humans?
Research has shown that tirzepatide has undergone safety testing in people, particularly those with obesity. These studies found tirzepatide to be effective and generally safe. Some participants experienced side effects, but these were usually mild and manageable. This suggests tirzepatide is likely well-tolerated, though individual experiences may vary. As this trial is in an early stage, it primarily aims to assess the safety and tolerability of tirzepatide for treating methamphetamine use disorder.12345
Why do researchers think this study treatment might be promising for methamphetamine addiction?
Tirzepatide is unique because it offers a fresh approach to tackling methamphetamine addiction, an area where current treatments like behavioral therapies and medications such as bupropion and naltrexone often fall short. Unlike these standard options, tirzepatide is a medication originally used for diabetes and obesity, which works by activating both the GIP and GLP-1 receptors involved in appetite regulation and reward pathways. This dual action mechanism could potentially reduce cravings and withdrawal symptoms, giving it an edge in treating addiction. Researchers are excited about tirzepatide's potential because it represents a new class of treatment with a different mechanism that could bring hope to those struggling with methamphetamine addiction.
What evidence suggests that tirzepatide might be an effective treatment for methamphetamine addiction?
Research has shown that tirzepatide, a drug primarily used for weight loss and diabetes, might also aid in treating methamphetamine addiction. In this trial, some participants will receive tirzepatide to assess its effectiveness for methamphetamine use disorder (MtUD). Studies have found that similar drugs, such as semaglutide, can reduce issues related to substance use. Early evidence suggests that tirzepatide could help individuals with MtUD by lessening cravings and supporting early remission, which involves reduced drug use. Other research indicates that medications like tirzepatide can decrease the incidence of new substance use cases. Although further research is necessary, these findings suggest tirzepatide could be a promising option for those facing methamphetamine addiction.12346
Who Is on the Research Team?
Manish Jha, MBBS
Principal Investigator
University of Texas Southwestern Medical Center
Are You a Good Fit for This Trial?
This trial is for adults with moderate or severe methamphetamine use disorder. Participants should be able to attend weekly visits and complete study procedures. People with certain medical or psychiatric conditions may not be eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive weekly subcutaneous injections of tirzepatide or placebo for 26 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tirzepatide
Trial Overview
The study compares tirzepatide, given as a weekly injection under the skin, to a placebo (saline) over 32 weeks. It aims to see if tirzepatide is safe and helps reduce methamphetamine use.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Eligible participants who are enrolled will receive once-weekly subcutaneous injections of tirzepatide for a 26-week period.
Eligible participants who are enrolled will receive once-weekly subcutaneous injections of saline for a 26-week period.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Citations
Effects of Semaglutide and Tirzepatide on Incidence and ...
This study aims to evaluate the effectiveness of semaglutide and tirzepatide, which are new and particularly potent GLP-1RAs, in reducing the incidence of and ...
Tirzepatide for Obesity and Meth Use Disorder
This is an open-label pilot study to evaluate the feasibility and preliminary efficacy of using tirzepatide. This study will enroll up to 45 individuals with ...
Randomized Controlled Trial of Tirzepatide for ...
tirzepatide is a safe and potentially efficacious treatment of MtUD. and early remission
4.
trial.medpath.com
trial.medpath.com/clinical-trial/831fbed5759fb27a/nct07825857-tirzepatide-methamphetamine-use-disorderRandomized Controlled Trial of Tirzepatide... | Clinical Trial
Secondary Outcomes · Tolerability - stopping of treatment(26 weeks) · Current craving for methamphetamine(27 weeks) · Early remission(27 weeks).
5.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT06745128/tirzepatide-for-obesity-and-meth-use-disorderTirzepatide for Obesity and Meth Use Disorder
This is an open-label pilot study to evaluate the feasibility and preliminary efficacy of using tirzepatide when prescribed for its United ...
Randomized Controlled Trial of Tirzepatide for ...
The central hypothesis of the proposed research is that tirzepatide is a safe and potentially efficacious treatment of MtUD.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.