An Open-Label Tirzepatide Trial for Comorbid Obesity and Stimulant Use Disorder

Conditions

• Cocaine Use Disorder
• Methamphetamine Use Disorder
• Obesity
• Stimulant Use Disorders

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Tirzepatide — DRUG
  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.

Study Details

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.

Key Dates

First listed

Jul 9, 2026

Start date

Aug 19, 2026

Status verified

Aug 2026

Primary completion

Feb 1, 2030

Completion

Mar 1, 2030

Study Design

Enrollment

45 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Tirzepatide Arm
  Eligible participants who are enrolled will receive once-weekly subcutaneous injections of tirzepatide for a 20-week period in accordance with FDA-prescribing label guidelines.

Primary Outcome Measure

Effect of tirzepatide on self-reported use of stimulants [ Time Frame: 32 weeks ]

Locations (1)

Find similar trials in Dallas, TX

Related Studies

• Improving Glycemic Control With Electrical Stimulation
  Recruiting · University of Texas, El Paso · El Paso, Texas
• Negative Pressure Wound Therapy in Healing Abdominal Incision in Obese Patients Undergoing Breast Reconstruction Surgery
  Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• RESET System Pivotal Trial (Rev F)
  Recruiting · Morphic Medical Inc. · Washington D.C., District of Columbia
• Sympathetic Transduction in Obesity-associated Hypertension (OB-HTN)
  EARLY_PHASE1 · Recruiting · University of Texas Southwestern Medical Center · Dallas, Texas