Recruiting
Phase 2

Tirzepatide

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT07825857

Conditions

Methamphetamine Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Tirzepatide

Placebo (saline)

Study Details

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

Conditions

Methamphetamine Use Disorder

Study ID

NCT07825857

Start date

Oct 23, 2026

Status verified date

Oct, 2026

Completion date

Aug, 2031

Anticipated

Primary completion date

Jul 1, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

228 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tirzepatide

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

placebo comparator: Placebo (Saline)

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

Interventions

Tirzepatide

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).

Placebo (saline)

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

Primary outcome measure

  • Treatment response [ Time Frame: 26 weeks ]

Central Contacts and Locations

Central contacts

Elizabeth Dedrick, BS

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

Shavonna Williams

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

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75247

Contacts

Teresa Slettebo, BA

214-998-5649teresa.slettebo@utsouthwestern.edu

Principal Investigator:

Manish Jha, MBBS

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Oct 26, 2026

Last verified

Oct, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-27. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-10-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.