University of Texas Southwestern Medical Center
This open label pilot study will assess the feasibility and preliminary efficacy of tirzepatide which will be prescribed under its FDA approved weight management indication in adults with moderate or severe methamphetamine, cocaine or prescription stimulant use disorder (MUD) who also meet criteria for obesity or overweight with comorbidities. Up to 30 participants will receive 20 weeks of once weekly tirzepatide, followed by an observational follow up period. The study also incorporates MRI at seven time points to explore neural biomarkers associated with treatment response. All participants will receive 12 weeks of contingency management (CM) combined with cognitive behavioral therapy (CBT). Together, these pharmacologic, neuroimaging, and behavioral components will evaluate tirzepatide's potential to improve health and substance use outcomes in individuals with MUD.
This is a phase two, open-label 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 as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of: 1) 30 kg/m2 or greater (obesity) or 2) 27kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea…
Inclusion Criteria: 1. Be 18 to 65 years of age, inclusive. 2. Be able to provide informed consent and ask relevant questions. 3. Stated willingness to comply with all study procedures and availability for the duration of the study. 4. Be willing to adhere to the study medication regimen 5. Meet DSM-5 criteria for moderate or severe methamphetamine, cocaine or prescription stimulant use disorder. 6. Self-report methamphetamine, cocaine or prescription stimulant use on 18 or more days in the 30-day period prior to written informed consent using the Timeline Followback (TLFB). 7. Have an initia…
Following the instructions of the FDA-approved prescribing label, participants will receive the tirzepatide injection subcutaneously in either the abdomen, thigh, or upper arm once weekly for 20 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, per prescribing label for tirzepatide. The recommended maintenance dosages per prescribing label are 5/mg/week, 10mg/week, or 15mg/week injected subcutaneously. Maximum dosage (up to 10mg/week) will be optimized for each individual. The 20-week treatment period will include initial 4-week of 2.5mg/week, followed by 16-week long once-weekly treatment with tirzepatide at a minimum dose of 5 mg/week (higher doses up to 10 mg/week as tolerated), that will be followed by an observational follow-up period every 4 weeks after week 20.
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