A Phase 2 interventional study of Tirzepatide and Placebo (saline) in Methamphetamine Use Disorder, sponsored by University of Texas Southwestern Medical Center. Recruiting at 4 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by University of Texas Southwestern Medical Center · Phase 2, Interventional, and Treatment
Among 10 studies in Substance-Related Disorders by University of Texas Southwestern Medical Center — 3 open to participants now, 3 under way, none of them phase 3. Substance-Related Disorders · University of Texas Southwestern Medical Center.
Among the 10 studies in Substance-Related Disorders by University of Texas Southwestern Medical Center, this one is one of 2 that started in 2026, is one of 2 in phase 2, and was the 9th registered.
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
Browse Substance-Related Disorders studies →3 of the 10 studies in Substance-Related Disorders by University of Texas Southwestern Medical Center are open now, in 1 country. Recruiting first, the newest first:
University of Texas Southwestern Medical Center · Sites in United States
Healthy volunteers
University of Texas Southwestern Medical Center · Sites in United States
Ages 18–65
By country, each count listing its studies:
Of the 266 Substance-Related Disorders studies recruiting now, 130 (49%) set no upper age limit and 118 (44%) stop at 75 or younger; 56 take children under 18; 89 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 228 is above the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Median enrollment 75 across the 7 interventional studies, 75 across the 3 observational. Of the 7 that completed or were terminated, 3 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
University of Texas Southwestern Medical Center is the lead sponsor of 1,012 studies on the registry; 201 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
1 of the studies in Substance-Related Disorders by University of Texas Southwestern Medical Center that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03906435University of Texas Southwestern Medical CenterPreventing Vulnerable Child Syndrome in the NICU With Cognitive Behavioral Therapy (PreVNT Trial) | 2026-12-01 |
Add it to your calendar (.ics) → With an account.
Among the 10 studies in Substance-Related Disorders by University of Texas Southwestern Medical Center, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
Methamphetamine use disorder (MtUD) affects over 1.5 million U.S. adults annually and has no FDA-approved treatments. Preclinical studies and observational data suggest that glucagon-like peptide-1 receptor agonists (GLP-1RAs) may reduce stimulant use. 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. This Phase 2 double-blind, randomized controlled trial will enroll 228 adults with moderate or severe MtUD to receive weekly subcutaneous tirzepatide (2.5 mg/week titrated to 15 mg/week or maximally tolerated dose) or placebo for 26 weeks, followed by 6 weeks of follow-up. Safety will be monitored throughout.
The study aims are to: (1) assess tolerability (treatment discontinuation) and safety (serious adverse events) of tirzepatide; and (2) evaluate preliminary efficacy, including reduction in methamphetamine use (Timeline Follow-back), treatment response (≥6 of 8 urine drug screen [UDS] negative in weeks 23-26), and early remission (no longer meeting Diagnostic and Statistical Manual 5th edition [DSM-5] criteria at week 26). Secondary/exploratory aims include assessing reductions in methamphetamine craving and cravings for other substances.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible participants who are enrolled will receive once-weekly subcutaneous injections of tirzepatide for a 26-week period.
Drug: Tirzepatide
Eligible participants who are enrolled will receive once-weekly subcutaneous injections of saline for a 26-week period.
Drug: Placebo (saline)
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
Eligible participants who are randomized to placebo group will receive once-weekly subcutaneous injections of saline for a 26-week period.
Treatment response
Proportion of participants who attain treatment response (≥6 of 8 urine drug screens (UDS) negative for methamphetamine in Weeks 23 to 26).
Time frame: 26 weeks
Tolerability - stopping of treatment
Proportion of participants discontinuing or stopping treatment before Week 26 visit.
Time frame: 26 weeks
Current craving for methamphetamine
Severity score (range: 0-70) on stimulant craving questionnaire, higher score reflects more severe craving.
Time frame: 27 weeks
Early remission
Proportion of participants no longer meeting DSM-5 criteria for at least 3 months (criterion for craving permitted) at the Week 27 visit.
Time frame: 27 weeks
Safety - occurrence of serious adverse event
Proportion of participants with the occurrence of serious adverse event any time on or after Week 1 visit that is deemed to be related to study drug.
Time frame: 26 weeks
Reduction in self-reported use of methamphetamine
From first day of Week 1 to last day of Week 26, participant's use of methamphetamine will be recorded as a binary variable (yes/no), and compared across the two treatment arms.
Time frame: 26 weeks
Worst past-week craving for methamphetamine
Visual analog scale (VAS) for drug craving for methamphetamine, rated on 0-100, higher score indicates more severe craving
Time frame: 27 weeks
Plan to share: Yes — IPD data will be shared based on NIH Policy of Data Management and Sharing.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Jul 2031, 56 months after the start.
Of 47 non-industry phase 2 interventional studies under Substance-Related Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 51. This study's planned 56 months is above that.
Counting every sponsor, half of 51 studies reached it within 35 months; a quarter within 24 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Tirzepatide
University of Texas Southwestern Medical Center →