Active, not recruitingPhase 2Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity, Methamphetamine Use Disorder
Full registry 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.
Treatments and study arms
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.
Primary outcomes
Effect of tirzepatide on self-reported use of methamphetamine36 weeksSelf-reported use of methamphetamine will be assessed through Timeline Followback. The Timeline Followback procedure will be used to elicit the participant's self-reported use of illicit substances, including but not limited to stimulants, and polysubstance use starting at the Screening Visit and continuing throughout study participation. During the Screening Visit, this form will be used to assess illicit use of substances for the 30-day period prior to written consent. During the study, TLFB will be administered to document the participant's self-reported use of illicit substances, nicotine, and tobacco for each visit since the previous TLFB assessment. Participant's drug of choice will be asked and determined by study coordinator and recorded along with the TLFB assessment.
