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:
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
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;
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);
Parallel
Tirzepatide
DrugEligible 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)
DrugEligible 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).
Tolerability - stopping of treatment
Proportion of participants discontinuing or stopping treatment before Week 26 visit.
Current craving for methamphetamine
Severity score (range: 0-70) on stimulant craving questionnaire, higher score reflects more severe craving.
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.
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.
Click on the lead sponsor to view all of their trials.
University of Texas Southwestern Medical Center
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
