Randomized Controlled Trial of Tirzepatide for Methamphetamine Use Disorder

NCT07825857 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STU20260467
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 4

Brief Summary

This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group trial evaluating the tolerability, safety, and preliminary efficacy of tirzepatide for the treatment of individuals with moderate or severe methamphetamine use disorder (MtUD). The central hypothesis of the proposed research is that tirzepatide is a safe and potentially efficacious treatment of MtUD. Participants will undergo study procedures over 32 weeks, including:

1. 1.completing self-assessments
2. 2.undergo brief physical and review of medical and psychiatric history
3. 3.provide urine and blood samples
4. 4.medical management sessions
5. 5.weekly subcutaneous study medication injections

Conditions

Methamphetamine Use Disorder

Keywords

methamphetamine; MUD; methamphetamine use disorder; tirzepatide; substance use; GLP-1

Outcome Measures

Primary Outcomes (1)

• Treatment response

  Proportion of participants who attain treatment response (≥6 of 8 urine drug screens (UDS) negative for methamphetamine in Weeks 23 to 26).

  26 weeks

Secondary Outcomes (6)

• Tolerability - stopping of treatment

  26 weeks

• Current craving for methamphetamine

  27 weeks

• Early remission

  27 weeks

• Safety - occurrence of serious adverse event

  26 weeks

• Reduction in self-reported use of methamphetamine

  26 weeks

Study Arms (2)

Tirzepatide

EXPERIMENTAL

Eligible participants who are enrolled will receive once-weekly subcutaneous injections of tirzepatide for a 26-week period.

Drug: Tirzepatide

Placebo (Saline)

PLACEBO COMPARATOR

Eligible participants who are enrolled will receive once-weekly subcutaneous injections of saline for a 26-week period.

Drug: Placebo (saline)

Interventions

Tirzepatide DRUG

Eligible participants who are randomized to treatment group will receive once-weekly subcutaneous injections of tirzepatide for a 26-week period. Tirzepatide will start at 2.5 mg/week with planned dose increases every four weeks in 2.5 mg/week increments up to a maximum of 15 mg/week (or the maximally tolerated dose).

Also known as: Zepbound, Mounjaro

Tirzepatide

Placebo (saline) DRUG

Eligible participants who are randomized to placebo group will receive once-weekly subcutaneous injections of saline for a 26-week period.

Placebo (Saline)

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 aged 18 to 65 years;
• have moderate or severe methamphetamine use disorder;
• have active pattern of methamphetamine use;
• be interested in reducing or stopping methamphetamine use;
• be able and willing to provide informed consent, comply with all study procedures, and adhere to weekly study medication injections;
• be overweight or obese (body mass index ≥25 kg/m²); and
• (only for biological females) agree to use acceptable contraception and undergo urine pregnancy testing unless unable to become pregnant

You may not qualify if:

• report using any glucagon like peptide 1 receptor agonists (GLP-1RA, including tirzepatide), sulfonylureas, or insulin in the past 90 days;
• have a current eating disorder or severe alcohol or substance use disorder;
• have personal or family history of medullary thyroid carcinoma, history of multiple endocrine neoplasia type 2, or hypersensitivity, angioedema, or anaphylaxis to GLP-1RAs or tirzepatide;
• have Stage 3 or higher chronic kidney disease, inadequately controlled diabetes, history of diabetic retinopathy, any unstable or serious medical or psychiatric condition, or any other reason or clinical condition that may either interfere with study participation or make the study participation unsafe (per investigator judgement);
• are currently pregnant, breastfeeding, or planning pregnancy;
• have received an investigational drug within 30 days of informed consent;
• require psychiatric hospitalization;
• have recent suicidal or current homicidal ideation;
• are incarcerated or in court-mandated residential placement;
• have unsafe use of alcohol, benzodiazepines, sedative/hypnotics, or other substances; or
• have use of concurrent medications that may pose safety risks or interfere with study procedures.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (4)

University of Southern California (USC)

Los Angeles, California, 90032, United States

Location

Center of Substance Use and Health

San Francisco, California, 94102, United States

Location

Oklahoma State University (OSU) Center for Health Services

Tulsa, Oklahoma, 74136, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Tirzepatide; Sodium Chloride

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

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; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Manish Jha, MBBS

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Dedrick, BS

CONTACT

469-602-2356; elizabeth.dedrick@utsouthwestern.edu

Shavonna Williams

CONTACT

469-602-1926; shavonna.williams@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor-Psychiatry

Model Details: Randomized, Double-Blind, Placebo-Controlled

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 17, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): August 1, 2031
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (4)