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New treatment option for Alcohol Use Disorder
Official title Tirzepatide for Alcohol Use Disorder
ClinicalTrials.gov ID: NCT06994338
What this study is testing
What is Tirzepatide?
Tirzepatide is an investigational medicine, given as an once-weekly injectable medicine, being studied as a potential treatment for alcohol use disorder.
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 objective of this Phase 2 randomized controlled trial is to evaluate the effects of weekly tirzepatide (vs. placebo) on alcohol consumption and cardiometabolic outcomes in adults with alcohol use disorder and overweight or obesity.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 65
You may be able to join if
- Meeting past-year DSM-5 criteria for AUD with at least moderate severity (≥ 4 symptoms)
- Average daily consumption of ≥40g (women) / ≥ 60 g (men) per day in the 28 days prior to baseline
- Body mass index ≥ 27kg/m2
- Willingness to attend weekly medication visits and complete all study procedures
- Ability to read and communicate in English
You likely can't join if
- Meeting past-year DSM-5 criteria for another substance use disorder (except tobacco use disorder or mild cannabis use disorder)
- Recent (past 30 day) self-report of illicit drug use (excluding cannabis) or non-prescribed opioids; or positive urine screen for illicit drugs. A...
- History of significant alcohol withdrawal, as indicated by history of seizure, delirium tremens; history of hospitalization for withdrawal-related...
- Recent (past 3 months) engagement in behavioral or pharmacological alcohol use treatment or currently mandated to receive treatment
- History of chronic or acute pancreatitis
- History of Type 1 or Type 2 diabetes, or diabetes-related conditions (e.g., diabetic retinopathy), or baseline HbA1C ≥ 6.5%
See the full eligibility criteria
- Meeting past-year DSM-5 criteria for AUD with at least moderate severity (≥ 4 symptoms)
- Average daily consumption of ≥40g (women) / ≥ 60 g (men) per day in the 28 days prior to baseline
- Body mass index ≥ 27kg/m2
- Willingness to attend weekly medication visits and complete all study procedures
- Ability to read and communicate in English
- Age 21-65
- Treatment-seeking (i.e., currently seeking assistance to reduce or stop drinking)
- Stable housing status
- Meeting past-year DSM-5 criteria for another substance use disorder (except tobacco use disorder or mild cannabis use disorder)
- Recent (past 30 day) self-report of illicit drug use (excluding cannabis) or non-prescribed opioids; or positive urine screen for illicit drugs. A positive screen for opioids will be allowed if the participant is...
- History of significant alcohol withdrawal, as indicated by history of seizure, delirium tremens; history of hospitalization for withdrawal-related symptoms; a CIWA score \>9 at assessment; or a baseline score 4+ on the...
- Recent (past 3 months) engagement in behavioral or pharmacological alcohol use treatment or currently mandated to receive treatment
- History of chronic or acute pancreatitis
- History of Type 1 or Type 2 diabetes, or diabetes-related conditions (e.g., diabetic retinopathy), or baseline HbA1C ≥ 6.5%
- History of suicide attempt or report of current (past 2 weeks) active suicidal ideation
- Lifetime diagnosis of severe mental illness (e.g., psychosis or bipolar disorder)
- Evidence of a significant anxiety or depressive disorder that is currently interfering with daily functioning, based on GAD-7 and PHQ-9 scores and physician judgement. (Anxiety or depression are not exclusionary if...
- Treatment for eating disorder in the past 12 months
- Report of significant medical, neurological, or psychiatric illness that would preclude safe or full study participation based on the judgement of the study physicians
- History of known liver disease
- Elevated serum lipase, amylase, bilirubin, or ALP, ALT, or AST (\>3x upper limit of normal range)
- History of malignant neoplasms in the last 5 years, except for non-melanoma skin cancer
- Inability to attend weekly clinic visits as scheduled (i.e., based on travel or work schedule)
- Weight loss \> 5% in the 30 days prior to screening
- Currently enrolled in another clinical trial involving an investigational product
- Current contact or co-habitation with a current or former participant in the present trial
- Current co-habitation with a person taking GLP-1RA therapy
- Planned surgical procedures requiring anesthesia within 90 days post-entry into the study
- History of treatment with tirzepatide or a GLP-1RA within 6 months of screening
- Treatment with any weight loss medications (e.g., orlistat, bupropion-naltrexone) or medications known to reduce alcohol consumption (e.g., naltrexone, topiramate, acamprosate, varenicline) in the past 3 months
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type I or type II
- Estimated glomerular filtration rate (eGFR) \<60 (indicated impaired kidney function)
- Use of prescribed or non-prescribed medications that would preclude safe use of tirzepatide in the judgement of the study physicians
- Known bone, muscle, or wasting conditions (e.g., osteoporosis, sarcopenia) aa. Presence of significant or uncontrolled GI conditions (e.g., GERD) that would interfere with treatment in the judgement of study physicians...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, 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 - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.