Using tirzepatide to treat obesity in people with methamphetamine use disorder

Tirzepatide for Individuals With Comorbid Obesity and Methamphetamine Use Disorder

This study is testing if weekly injections of tirzepatide can help people with methamphetamine use disorder lose weight while they follow a low-calorie diet and exercise more.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Texas Southwestern Medical Center (other)
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT06745128 on ClinicalTrials.gov

What this trial studies

This open-label pilot study aims to evaluate the feasibility and preliminary efficacy of tirzepatide in individuals with moderate-to-severe methamphetamine use disorder who also meet the FDA-approved criteria for weight management. The study will enroll up to 45 participants who will receive weekly tirzepatide injections for 32 weeks, alongside a reduced-calorie diet and increased physical activity. Participants will undergo weekly clinical and laboratory assessments to monitor their progress and adherence to the treatment regimen. The study seeks to understand how tirzepatide can help manage weight in this specific population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with moderate to severe methamphetamine use disorder and a BMI of 27 or greater, along with at least one weight-related comorbidity.

Not a fit: Patients who do not meet the criteria for methamphetamine use disorder or have a BMI below 27 may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for individuals struggling with obesity and methamphetamine use disorder.

How similar studies have performed: While the combination of tirzepatide for obesity and methamphetamine use disorder is novel, similar studies have shown promise in using medications for weight management in substance use populations.

Eligibility criteria

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 use disorder.
6. Self-report methamphetamine use on 18 or more days in the 30-day period prior to written informed consent using the Timeline Followback (TLFB).
7. Have an initial body mass index (BMI) at screening of:

   1. 30 kg/m2 or greater (obesity)
   2. 27 kg/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 or cardiovascular disease).
8. If biologically female and is or becomes sexually active with a biological male, must agree to use acceptable methods of contraception and have urine pregnancy testing during participation in the study, unless unable to get pregnant

   a. Appropriate birth control methods include: i. Oral contraceptives, contraceptive patch, hormonal vaginal contraceptive ring (with restrictions related to dose change given the medication interactions between tirzepatide and oral contraceptives).

   ii. Barrier (diaphragm or condom) iii. Contraceptive implant iv. Medroxyprogesterone acetate injection v. Intra-uterine device vi. Complete abstinence from sexual intercourse vii. Surgical sterilization
9. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration

Exclusion Criteria:

1. Current or recent use (within 3 months prior to consent) of other tirzepatide-containing products or any other GLP-1 receptor agonist
2. Current or recent use (within 30 days) of sulfonylureas, other concomitantly administered insulin secretagogue, or insulin
3. Current or recent use (within 3 months prior to consent) of other weight loss agents
4. Weight loss surgery within 12 months prior to consent
5. Current eating disorder per clinician evaluation
6. Personal or family history of Medullary Thyroid Carcinoma
7. History of Multiple Endocrine Neoplasia syndrome type 2
8. Known serious hypersensitivity (e.g., anaphylaxis, angioedema) to tirzepatide or any of the excipients in tirzepatide
9. History of angioedema or anaphylaxis with a GLP-1 receptor agonist
10. Current Stage 3 or higher Chronic Kidney Disease, defined as eGFR \<60 at Screening
11. Current inadequately controlled diabetes, defined as HbA1c \> 7.0 at Screening
12. History of diabetic retinopathy
13. Current pregnancy or lactation
14. Treatment with another investigational drug or intervention within the past one month (30 days prior to consent)
15. Have any condition for which study participation would not be in their best interest (e.g., cognitive impairment, unstable general medical condition, intoxication, active psychosis) or that could prevent, limit, or confound the protocol-specified assessments, in the opinion of the investigator or their designee.
16. Require immediate hospitalization for psychiatric disorder or suicidal risk as assessed by a licensed study clinician.

Where this trial is running

Dallas, Texas

• UT Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Manish Jha, M.B.B.S. — University of Texas Southwestern Medical Center
• Study coordinator: Virgilio Garza, B.S.

Conditions: Obesity, Methamphetamine Use Disorder, Methamphetamine, MUD, Overweight, Tirzepatide, Weight management