Randomized Controlled Trial of Tirzepatide for Methamphetamine Use Disorder

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT07825857
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Methamphetamine Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — 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.

Study Details

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

Key Dates

First listed
Sep 17, 2026
Start date
Oct 1, 2026
Status verified
Sep 2026
Primary completion
Jul 1, 2031
Completion
Aug 31, 2031

Study Design

Enrollment
228 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide
    Eligible participants who are enrolled will receive once-weekly subcutaneous injections of tirzepatide for a 26-week period.
  • Placebo Comparator: Placebo (Saline)
    Eligible participants who are enrolled will receive once-weekly subcutaneous injections of saline for a 26-week period.

Primary Outcome Measure

Treatment response [ Time Frame: 26 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Southern California (USC)Los AngelesCalifornia90032
Jimena Estrada
[email protected]
386-846-6139
Center of Substance Use and HealthSan FranciscoCalifornia94102
Xochitl Luna Marti
[email protected]
628-217-6235
Samantha Serrano
[email protected]
Oklahoma State University (OSU) Center for Health ServicesTulsaOklahoma74136
Katie Thompson, BS
[email protected]
603-978-2208

Find similar trials in Los Angeles, CA

By research site
University of Southern California (USC)· Los Angeles, CACenter of Substance Use and Health· San Francisco, CAOklahoma State University (OSU) Center for Health Services· Tulsa, OK

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