Randomized Controlled Trial of Tirzepatide for Methamphetamine Use Disorder

What Was Tested

In this phase 2 trial, researchers set out to test Tirzepatide.

It had two arms (groups): Tirzepatide (experimental) and Placebo (Saline) (placebo comparator).

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

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

The registry classes the interventions as drug.

More on the Plan

Tirzepatide, a dual GLP-1/glucose-dependent insulinotropic peptide (GIP) receptor agonist approved for type 2 diabetes and weight management, has not been evaluated for MtUD in an adequately-powered randomized controlled trial.

Safety will be monitored throughout.

Who Took Part

Enrollment: 228 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Be aged 18 to 65 years;. Have moderate or severe methamphetamine use disorder;. Have active pattern of 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.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: 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;.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Tirzepatide group and the comparison group ran side by side rather than switching.

As a double-blind Tirzepatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-10-01 with completion listed for 2031-07-01.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Treatment response (time frame: 26 weeks).

It also tracked 6 secondary outcomes, for example Tolerability - stopping of treatment, Current craving for methamphetamine, Early remission, Safety - occurrence of serious adverse event and Worst past-week craving for methamphetamine.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tirzepatide in 228 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.