Randomized Controlled Trial of Tirzepatide for Methamphetamine Use Disorder
Key facts
- Who runs it
- University of Texas Southwestern Medical Center
- Where
- Dallas, Los Angeles, San Francisco, and Tulsa, United StatesSee the 4 sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 228 people, planned
- Started
- 23 Oct 2026
- Expected to end
- Aug 2031
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Tirzepatide
- Placebo (saline)
- Record updated
- 26 October 2026
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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 take part
- have received an investigational drug within 30 days of informed consent
- have use of concurrent medications that may pose safety risks or interfere with study procedures
- 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)
- require psychiatric hospitalization
- report using any glucagon like peptide 1 receptor agonists (GLP-1RA, including tirzepatide), sulfonylureas, or insulin in the past 90 days
- are currently pregnant, breastfeeding, or planning pregnancy
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in United States
- UT Southwestern Medical CenterDallas, United StatesContact: Teresa Slettebo, BATaking people
- University of Southern California (USC)Los Angeles, United StatesContact: Jimena EstradaNot yet recruiting
- Center of Substance Use and HealthSan Francisco, United StatesContact: Xochitl Luna MartiNot yet recruiting
- Oklahoma State University (OSU) Center for Health ServicesTulsa, United StatesContact: Katie Thompson, BSNot yet recruiting
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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
The 2 groups in the trial
- TirzepatideTreatment being tested
Eligible participants who are enrolled will receive once-weekly subcutaneous injections of tirzepatide for a 26-week period.
- Placebo (Saline)Placebo, for comparison
Eligible participants who are enrolled will receive once-weekly subcutaneous injections of saline for a 26-week period.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT07825857, who can take part
- Record updated
- 26 October 2026