Randomized Controlled Trial of Tirzepatide for Methamphetamine Use Disorder

What this study is testing ClinicalTrials.gov NCT07825857 ↗

Description as written by the study sponsor.

This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group trial evaluating the tolerability, safety, and preliminary efficacy of tirzepatide for the treatment of individuals with moderate or severe methamphetamine use disorder (MtUD). The central hypothesis of the proposed research is that tirzepatide is a safe and potentially efficacious treatment of MtUD. Participants will undergo study procedures over 32 weeks, including: 1. completing self-assessments 2. undergo brief physical and review of medical and psychiatric history 3. provide urine and blood samples 4. medical management sessions 5. weekly subcutaneous study medication injections

Treatments tested

• Tirzepatide also known as Zepbound, Mounjaro Drug

  Eligible participants who are randomized to treatment group will receive once-weekly subcutaneous injections of tirzepatide for a 26-week period. Tirzepatide will start at 2.5 mg/week with planned dose increases every four weeks in 2.5 mg/week increments up to a maximum of 15 mg/week (or the maximally tolerated dose).

• Placebo (saline) Drug

  Eligible participants who are randomized to placebo group will receive once-weekly subcutaneous injections of saline for a 26-week period.