Methamphetamine Use DisorderPhase 2T-STEMNCT07825857
Randomized Controlled Trial of Tirzepatide for Methamphetamine Use Disorder
A Phase 2 study testing Tirzepatide in people with Methamphetamine Use Disorder, run by University of Texas Southwestern Medical Center at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Methamphetamine Use Disorder
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 4 sitesUnited States
- Study dates
- 23 Oct 2026to Aug 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75247
Teresa Slettebo, BA, 214-998-5649, teresa.slettebo@utsouthwestern.edu
Manish Jha, MBBS
- Not yet recruiting
University of Southern California (USC)
Los Angeles, California, 90032
Jimena Estrada, 213-962-0698, jimenaes@usc.edu
Christian Hendershot, PhD
- Not yet recruiting
Center of Substance Use and Health
San Francisco, California, 94102
Xochitl Luna Marti, 628-217-6235, xochitl.lunamarti@sfdph.org
Samantha Serrano, samantha.serrano@sfdph.org
- Not yet recruiting
Oklahoma State University (OSU) Center for Health Services
Tulsa, Oklahoma, 74136
Katie Thompson, BS, 603-978-2208, kthompson@okstate.edu
Kyle Simmons, PhD
About this study
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:
- completing self-assessments
- undergo brief physical and review of medical and psychiatric history
- provide urine and blood samples
- medical management sessions
- weekly subcutaneous study medication injections
Read the detailed description
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.
- Conditions
- Methamphetamine Use Disorder
- Being tested
- Tirzepatide, Placebo (saline)
- Keywords
- methamphetamine, MUD, methamphetamine use disorder, tirzepatide, substance use, GLP-1
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called Zepbound, Mounjaro
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)Drug
Eligible participants who are randomized to placebo group will receive once-weekly subcutaneous injections of saline for a 26-week period.
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide | Experimental | Eligible participants who are enrolled will receive once-weekly subcutaneous injections of tirzepatide for a 26-week period. Receives: Drug: Tirzepatide |
| Placebo (Saline) | Placebo comparator | Eligible participants who are enrolled will receive once-weekly subcutaneous injections of saline for a 26-week period. Receives: Drug: Placebo (saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response
Proportion of participants who attain treatment response (≥6 of 8 urine drug screens (UDS) negative for methamphetamine in Weeks 23 to 26).
Measured: 26 weeks
Secondary outcomes (6)
Tolerability - stopping of treatment
Proportion of participants discontinuing or stopping treatment before Week 26 visit.
Measured: 26 weeks
Current craving for methamphetamine
Severity score (range: 0-70) on stimulant craving questionnaire, higher score reflects more severe craving.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 27 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start23 Oct 2026
- Primary completion1 Jul 2031 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-Controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Manish Jha, University of Texas Southwestern Medical Center
- Investigators
- Manish Jha, MBBS, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825857
- Sponsor's protocol ID
- STU20260467
- Acronym
- T-STEM
- Status last verified
- Oct 2026
- First submitted
- 11 Sep 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD data will be shared based on NIH Policy of Data Management and Sharing.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Tirzepatide for Methamphetamine Use Disorder
- ClinicalTrials.gov ID
- NCT07825857
- Acronym / sponsor ID
- T-STEM / STU20260467
- Conditions
- Methamphetamine Use Disorder
- Keywords
- methamphetamine, MUD, methamphetamine use disorder, tirzepatide, substance use, GLP-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 23 Oct 2026 (actual)
- Primary completion
- 1 Jul 2031 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- completing self-assessments
- undergo brief physical and review of medical and psychiatric history
- provide urine and blood samples
- medical management sessions
- weekly subcutaneous study medication injections
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double-Blind, Placebo-Controlled
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide | Experimental | Drug: TirzepatideEligible participants who are enrolled will receive once-weekly subcutaneous injections of tirzepatide for a 26-week period. |
| Placebo (Saline) | Placebo comparator | Drug: Placebo (saline)Eligible participants who are enrolled will receive once-weekly subcutaneous injections of saline for a 26-week period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideAlso: Zepbound, MounjaroEligible 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). | Drug | Tirzepatide |
| Placebo (saline)Eligible participants who are randomized to placebo group will receive once-weekly subcutaneous injections of saline for a 26-week period. | Drug | Placebo (Saline) |
Primary outcome
Treatment response
Time frame: 26 weeks
Proportion of participants who attain treatment response (≥6 of 8 urine drug screens (UDS) negative for methamphetamine in Weeks 23 to 26).
6 secondary outcomes
Tolerability - stopping of treatment
Time frame: 26 weeks
Current craving for methamphetamine
Time frame: 27 weeks
Early remission
Time frame: 27 weeks
Safety - occurrence of serious adverse event
Time frame: 26 weeks
Reduction in self-reported use of methamphetamine
Time frame: 26 weeks
Worst past-week craving for methamphetamine
Time frame: 27 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. IPD data will be shared based on NIH Policy of Data Management and Sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manish Jha, MBBS principal investigator
University of Texas Southwestern Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tirzepatide in people with Methamphetamine Use Disorder, run by University of Texas Southwestern Medical Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Dedrick, BS (469-602-2356, elizabeth.dedrick@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.