Tirzepatide for Methamphetamine Addiction

(T-STEM Trial)

Not yet recruiting at 3 trial locations
SW
Overseen ByShavonna Williams
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Texas Southwestern Medical Center
Prior Safety DataThis treatment has passed at least one previous human 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?

MJ

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

Have active pattern of methamphetamine use
I want to reduce or stop using methamphetamine.
I am willing and able to consent, follow study rules, and get weekly injections.
See 4 more

Exclusion Criteria

Are currently pregnant, breastfeeding, or planning pregnancy
Have a current eating disorder or severe alcohol or substance use disorder
Are incarcerated or in court-mandated residential placement
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly subcutaneous injections of tirzepatide or placebo for 26 weeks

26 weeks
Weekly visits for subcutaneous injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks
Regular follow-up visits

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

Group I: TirzepatideExperimental Treatment1 Intervention
Group II: Placebo (Saline)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

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

Randomized Controlled Trial of Tirzepatide... | Clinical Trial

Secondary Outcomes · Tolerability - stopping of treatment(26 weeks) · Current craving for methamphetamine(27 weeks) · Early remission(27 weeks).

Tirzepatide 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.