Methamphetamine Use Disorder study: Tirzepatide
Official title Randomized Controlled Trial of Tirzepatide for Methamphetamine Use Disorder
ClinicalTrials.gov ID: NCT07825857
What this study is testing
What is Tirzepatide?
This is an investigational once-weekly injectable medicine being studied as a potential treatment for methamphetamine use disorder. It is designed to activate specific receptors in the body that help regulate blood sugar and appetite.
Also referred to as Zepbound, Mounjaro.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if tirzepatide is safe and might help people who use methamphetamine. It will look at how well the drug works and any side effects.
- Who it's for
- It is looking for adults who have moderate or severe methamphetamine use disorder.
- What's involved
- Participants will get weekly injections of the study drug or a placebo, fill out self‑reports, have brief physical exams, give urine and blood samples, and attend medical management sessions.
- Time commitment
- The study lasts 32 weeks and includes weekly visits for injections and regular check‑ins.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 32 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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;
You likely can't join if
- 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...
- have Stage 3 or higher chronic kidney disease, inadequately controlled diabetes, history of diabetic retinopathy, any unstable or serious medical or...
- are currently pregnant, breastfeeding, or planning pregnancy;
- have received an investigational drug within 30 days of informed consent;
See the full eligibility criteria
- 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
- 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...
- are currently pregnant, breastfeeding, or planning pregnancy;
- have received an investigational drug within 30 days of informed consent;
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 32 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.