University of Texas Southwestern Medical Center
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 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
Methamphetamine use disorder (MtUD) affects over 1.5 million U.S. adults annually and has no FDA-approved treatments. Preclinical studies and observational data suggest that glucagon-like peptide-1 receptor agonists (GLP-1RAs) may reduce stimulant use. Tirzepatide, a dual GLP-1/glucose-dependent insulinotropic peptide (GIP) receptor agonist approved for type 2 diabetes and weight management, has not been evaluated for MtUD in an adequately-powered randomized controlled trial. This Phase 2 double-blind, randomized controlled trial will enroll 228 adults with moderate or severe MtUD to receive w…
Inclusion Criteria: * be aged 18 to 65 years; * have moderate or severe methamphetamine use disorder; * have active pattern of methamphetamine use; * be interested in reducing or stopping methamphetamine use; * be able and willing to provide informed consent, comply with all study procedures, and adhere to weekly study medication injections; * be overweight or obese (body mass index ≥25 kg/m²); and * (only for biological females) agree to use acceptable contraception and undergo urine pregnancy testing unless unable to become pregnant Exclusion Criteria: * report using any glucagon like pep…
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).
Eligible participants who are randomized to placebo group will receive once-weekly subcutaneous injections of saline for a 26-week period.
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