Tirzepatide for Obesity and Meth Use Disorder

NCT06745128 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: STU-2024-1221
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Methamphetamine Use Disorder

Keywords

Methamphetamine; Methamphetamine Use Disorder; MUD; Overweight; Obesity; Tirzepatide; Weight management

Outcome Measures

Primary Outcomes (1)

• Effect of tirzepatide on self-reported use of methamphetamine

  Self-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.

  36 weeks

Secondary Outcomes (5)

• Feasibility of using tirzepatide in individuals with Methamphetamine Use Disorder

  4 weeks

• Changes in body mass index from baseline to the end of the 32-week treatment phase

  32 weeks

• Changes in self-reported symptoms of anhedonia from baseline to the end of the 32-week treatment phase

  32 weeks

• Changes in High-sensitivity C-reative protein (hs-CRP) levels from baseline to the end of the 32-week treatment phase

  32 weeks

• Changes in gastrointestinal symptom severity from baseline until the end of the 32-week treatment phase

  32 weeks

Study Arms (1)

Tirzepatide

EXPERIMENTAL

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.

Drug: Tirzepatide

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.

Also known as: ZEPBOUND, MOUNJARO

Tirzepatide

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 18 to 65 years of age, inclusive.
• Be able to provide informed consent and ask relevant questions.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Be willing to adhere to the study medication regimen
• Meet DSM-5 criteria for moderate or severe methamphetamine use disorder.
• Self-report methamphetamine use on 18 or more days in the 30-day period prior to written informed consent using the Timeline Followback (TLFB).
• Have an initial body mass index (BMI) at screening of:
• kg/m2 or greater (obesity)
• 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).
• 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
• Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration

You may not qualify if:

• Current or recent use (within 3 months prior to consent) of other tirzepatide-containing products or any other GLP-1 receptor agonist
• Current or recent use (within 30 days) of sulfonylureas, other concomitantly administered insulin secretagogue, or insulin
• Current or recent use (within 3 months prior to consent) of other weight loss agents
• Weight loss surgery within 12 months prior to consent
• Current eating disorder per clinician evaluation
• Personal or family history of Medullary Thyroid Carcinoma
• History of Multiple Endocrine Neoplasia syndrome type 2
• Known serious hypersensitivity (e.g., anaphylaxis, angioedema) to tirzepatide or any of the excipients in tirzepatide
• History of angioedema or anaphylaxis with a GLP-1 receptor agonist
• Current Stage 3 or higher Chronic Kidney Disease, defined as eGFR \<60 at Screening
• Current inadequately controlled diabetes, defined as HbA1c \> 7.0 at Screening
• History of diabetic retinopathy
• Current pregnancy or lactation
• Treatment with another investigational drug or intervention within the past one month (30 days prior to consent)
• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75247, United States

Location

Related Publications (8)

• Volkow ND, Xu R. GLP-1R agonist medications for addiction treatment. Addiction. 2025 Feb;120(2):198-200. doi: 10.1111/add.16626. Epub 2024 Jul 24.

  PMID: 39049203 BACKGROUND

• Lahteenvuo M, Tiihonen J, Solismaa A, Tanskanen A, Mittendorfer-Rutz E, Taipale H. Repurposing Semaglutide and Liraglutide for Alcohol Use Disorder. JAMA Psychiatry. 2025 Jan 1;82(1):94-98. doi: 10.1001/jamapsychiatry.2024.3599.

  PMID: 39535805 BACKGROUND

• Coffin PO, Suen LW. Methamphetamine Toxicities and Clinical Management. NEJM Evid. 2023 Dec;2(12):EVIDra2300160. doi: 10.1056/EVIDra2300160. Epub 2023 Nov 28.

  PMID: 38320504 BACKGROUND

• Kulich KR, Madisch A, Pacini F, Pique JM, Regula J, Van Rensburg CJ, Ujszaszy L, Carlsson J, Halling K, Wiklund IK. Reliability and validity of the Gastrointestinal Symptom Rating Scale (GSRS) and Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire in dyspepsia: a six-country study. Health Qual Life Outcomes. 2008 Jan 31;6:12. doi: 10.1186/1477-7525-6-12.

  PMID: 18237386 BACKGROUND

• Tan B, Pan XH, Chew HSJ, Goh RSJ, Lin C, Anand VV, Lee ECZ, Chan KE, Kong G, Ong CEY, Chung HC, Young DY, Chan MY, Khoo CM, Mehta A, Muthiah MD, Noureddin M, Ng CH, Chew NWS, Chin YH. Efficacy and safety of tirzepatide for treatment of overweight or obesity. A systematic review and meta-analysis. Int J Obes (Lond). 2023 Aug;47(8):677-685. doi: 10.1038/s41366-023-01321-5. Epub 2023 May 31.

  PMID: 37253796 BACKGROUND

• Barry D, Clarke M, Petry NM. Obesity and its relationship to addictions: is overeating a form of addictive behavior? Am J Addict. 2009 Nov-Dec;18(6):439-51. doi: 10.3109/10550490903205579.

  PMID: 19874165 BACKGROUND

• Franken IH, Rassin E, Muris P. The assessment of anhedonia in clinical and non-clinical populations: further validation of the Snaith-Hamilton Pleasure Scale (SHAPS). J Affect Disord. 2007 Apr;99(1-3):83-9. doi: 10.1016/j.jad.2006.08.020. Epub 2006 Sep 20.

  PMID: 16996138 BACKGROUND

• Sobell LC, Sobell MB, Leo GI, Cancilla A. Reliability of a timeline method: assessing normal drinkers' reports of recent drinking and a comparative evaluation across several populations. Br J Addict. 1988 Apr;83(4):393-402. doi: 10.1111/j.1360-0443.1988.tb00485.x. No abstract available.

  PMID: 3395719 BACKGROUND

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Manish Jha, M.B.B.S.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MBBS, Associate Professor

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: February 3, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)