Tirzepatide for Alcoholism

Overseen By Christian Hendershot, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Southern California

Must not be taking: Weight loss, Alcohol reduction

Disqualifiers: Substance use disorder, Diabetes, Severe mental illness, Liver disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called tirzepatide to determine if it can help people with alcohol use disorder drink less and improve their overall health. Participants will receive either tirzepatide or a placebo (a non-active substance) to compare results. Suitable candidates typically drink more than average, have a higher body weight, and seek to reduce their drinking. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it mentions that certain medications might not be safe with tirzepatide. It's best to discuss your current medications with the study physicians to ensure they are safe to continue.

Is there any evidence suggesting that tirzepatide is likely to be safe for humans?

Research shows that tirzepatide is generally safe and well-tolerated. Although specific data on its safety for treating alcohol use disorder is limited, its approval for weight management suggests reasonable safety. Users of tirzepatide for other conditions have reported side effects such as nausea and diarrhea, but these were typically mild and temporary. This trial is in an early phase, focusing on safety, and earlier research has shown enough promise for the treatment to reach this stage. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for alcoholism?

Tirzepatide is unique because it offers a fresh approach to treating alcoholism by targeting the GLP-1 and GIP receptors, which are not typically addressed by current alcohol use disorder treatments like disulfiram or naltrexone. These receptors play a crucial role in regulating appetite and metabolism, and by influencing them, tirzepatide may help reduce alcohol cravings and consumption. Researchers are excited about tirzepatide because it could provide a new mechanism for managing alcoholism, potentially offering benefits beyond traditional medications that focus solely on alcohol dependence pathways.

What evidence suggests that tirzepatide might be an effective treatment for alcohol use disorder?

Research has shown that tirzepatide, which participants in this trial may receive, might help reduce alcohol consumption. In studies, rats given tirzepatide consumed less alcohol. Additionally, individuals taking medications like tirzepatide and semaglutide had fewer drinks and were less likely to binge drink. Some weight loss drugs, including tirzepatide, may reduce alcohol and drug use overall, possibly because these drugs alter the brain's response to alcohol. Overall, early evidence suggests tirzepatide could help individuals with alcohol use disorder drink less. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults who struggle with alcohol use disorder and are also overweight or obese. Participants should be seeking treatment for their alcohol consumption.

Inclusion Criteria

Meeting past-year DSM-5 criteria for AUD with at least moderate severity (≥ 4 symptoms)

Treatment-seeking (i.e., currently seeking assistance to reduce or stop drinking)

Average daily consumption of ≥40g (women) / ≥ 60 g (men) per day in the 28 days prior to baseline

Exclusion Criteria

Currently enrolled in another clinical trial involving an investigational product

Treatment for eating disorder in the past 12 months

Current contact or co-habitation with a current or former participant in the present trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly tirzepatide or placebo to evaluate effects on alcohol consumption and cardiometabolic outcomes

8 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tirzepatide

Trial Overview The study tests the effects of tirzepatide, a weekly injection, against a placebo to see if it helps reduce alcohol intake and improve heart-related health measures in participants.

How Is the Trial Designed?

Group I: Tirzepatide Experimental Treatment 1 Intervention

2.5mg (Weeks 1-4), 5.0mg (Weeks 5-8)

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06939088

NCT06939088 | Effects of Tirzepatide on Alcohol Intake in ... The primary endpoint will be a change in alcohol consumption, measured as a per cent change in heavy drinking days after 16 weeks of treatment with tirzepatide ...

2. nature.com nature.com/articles/s41598-023-48267-2

Semaglutide and Tirzepatide reduce alcohol consumption ... Overall, both average drinks and odds of binge drinking were found to be significantly lower in the medication groups i.e., Semaglutide and ...

3. biorxiv.org biorxiv.org/content/10.1101/2025.08.26.672374v1.full-text

Tirzepatide attenuates dopamine reward signaling and ... Acute tirzepatide treatment dose-dependently reduces alcohol consumption in male and female rats. To further assess tirzepatide's effectiveness ...

4. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2829811

Once-Weekly Semaglutide in Adults With Alcohol Use ... Over 9 weeks of treatment, semaglutide led to reductions in some but not all measures of weekly consumption, significantly reduced weekly alcohol craving ...

5. recoveryanswers.org recoveryanswers.org/research-post/can-new-weight-loss-drugs-ozempic-reduce-alcohol-drug-use/

Can new weight loss drugs like Ozempic also reduce ... Preliminary findings show a correlation between semaglutide/tirzepatide-type weight loss medications and lower alcohol and other drug use.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07046819

Study Details | NCT07046819 | Tirzepatide in MetALD We hypothesize that tirzepatide will be well tolerated and safe in this new target population and that tirzepatide will achieve reduction in alcohol use, ...

7. clinicalstudies.info.nih.gov clinicalstudies.info.nih.gov/protocoldetails.aspx?id=002246-AA&&query=Fatal

NIH Clinical Center: Search the Studies MetALD can be fatal. An approved weight management drug (Tirzepatide) may be able to help people with AUD and MetALD control their alcohol intake. Objective: ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0033062024001798

Tirzepatide and semaglutide for treating obesity-related ... Early clinical studies have supported these findings, showing that patients treated with GLP-1RAs report reduced craving for and consumption of alcoholic drinks ...