RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Tirzepatide for Methamphetamine Use Disorder

This is a phase 2, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group trial evaluating the tolerability, safety, and preliminary how well it works 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.

Official registry: https://clinicaltrials.gov/study/NCT07825857 · University of Texas Southwestern Medical Center · enrollment listed as 228

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Tirzepatide, or Placebo (saline). The registry lists allocation as randomized. This is a phase 2, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group trial evaluating the tolerability, safety, and preliminary how well it works of tirzepatide for the treatment of individuals with moderate or severe methamphetamine use disorder (MtUD).

They plan to enroll about 228 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Randomized Controlled Trial of Tirzepatide for Methamphetamine Use Disorder

Interventions: Tirzepatide, Placebo (saline)

Primary outcome (registry wording): Treatment response

Who it is for (from inclusion criteria)

Ages 18 Years to 65 Years
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 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

Who the registry excludes

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;
are currently pregnant, breastfeeding, or planning pregnancy;
require psychiatric hospitalization;
have recent suicidal or current homicidal ideation;
are incarcerated or in court-mandated residential placement;

Public study contact (from the registry)

Elizabeth Dedrick, BS

469-602-2356

elizabeth.dedrick@utsouthwestern.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

4 listed

University of Southern California (USC) — Los Angeles, California (not_yet_recruiting)
Center of Substance Use and Health — San Francisco, California (not_yet_recruiting)
Oklahoma State University (OSU) Center for Health Services — Tulsa, Oklahoma (not_yet_recruiting)
UT Southwestern Medical Center — Dallas, Texas (recruiting)

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FAQ about this NCT record

Is NCT07825857 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07825857?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07825857?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary