Tirzepatide for Obesity and Meth Use Disorder

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT06745128
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Methamphetamine Use Disorder
  • Obesity

Eligibility Criteria

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

Interventions

  • Tirzepatide — DRUG
    Eligible participants who are enrolled will receive once-weekly subcutaneous injections of tirzepatide for a 32-week period. Following the instructions of the FDA-approved prescribing label, participants or a licensed study clinician will administer the tirzepatide injection subcutaneously in either the abdomen, thigh, or upper arm once weekly for 32 weeks total. Following the instructions of the FDA-approved prescribing label, the dosing schedule will include a 4-week titration at a starting dosage of 2.5mg/week. After four weeks, dosage will be increased in 2.5mg increments. The recommended maintenance dosages per prescribing label are 5mg/week, 10mg/week, or 15mg/week injected subcutaneously. Maximum dosage (up to 15mg/week) will be optimized for each individual. We will use commercially available tirzepatide, primarily dispensed as ZEPBOUND® for this study, but in the event of medication shortage or other pharmacy-related issue, MOUNJARO® may be dispensed as an alternative.

Study Details

This is an open-label pilot study to evaluate the feasibility and preliminary efficacy of using tirzepatide when prescribed for its United States (US) Food and Drug Administration (FDA)-approved weight-related indication in individuals with comorbid methamphetamine use disorder.

Key Dates

Start date
Feb 3, 2025
Status verified
Jun 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide
    Eligible participants who are enrolled will receive once-weekly subcutaneous injections of tirzepatide for a 32-week period in accordance with FDA-prescribing label guidelines.

Primary Outcome Measure

Effect of tirzepatide on self-reported use of methamphetamine [ Time Frame: 36 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical CenterDallasTexas75247-

Find similar trials in Dallas, TX

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
UT Southwestern Medical Center· Dallas, TX

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