Randomized trial of tirzepatide for alcohol use disorder begins enrolling

A randomized phase 2 trial testing tirzepatide (sold as Mounjaro and Zepbound) as a treatment for alcohol use disorder has begun recruiting participants, according to its registration on ClinicalTrials.gov ^[1]. The listing, identified as NCT06994338, gives an estimated enrollment of 42 adults and an estimated completion date of August 2026 ^[1]. Tirzepatide is not approved for alcohol use disorder ^[1].

The trial is sponsored by the University of Southern California and funded by the National Institute on Alcohol Abuse and Alcoholism ^[1]. To take part, people must be adults who have alcohol use disorder and are overweight or obese ^[1]. The primary outcome — the main measure researchers will use to judge whether the drug works — is heavy drinking days ^[1].

The listing describes the study as randomized and phase 2 ^[1]. It does not disclose the dose of tirzepatide being tested, how long participants will be treated, or whether participants will also receive a placebo ^[1]. No results have been posted ^[1].

Tirzepatide is approved in the United States for other conditions, but not for alcohol use disorder, so the trial is testing a new use of an existing drug ^[1]. Because the study is limited to 42 participants, it is an early test of the idea rather than a final answer ^[1].

Why it matters for patients

People taking GLP-1 medications for diabetes or weight management sometimes report that their drinking habits changed, and researchers have been trying to work out whether that is a real drug effect or something else. This trial is a randomized test of that question for tirzepatide, but no one can say yet whether the drug helps people drink less ^[1]. Nothing has been published from the study, and the estimated completion date is more than a year out ^[1].

Because tirzepatide is not approved for alcohol use disorder ^[1], a prescription written specifically to treat drinking would fall outside the drug's approved uses, and there is no approved product labeling describing how it should be used for that purpose. The trial record does not describe what participants are told about the drug's approved uses, what dose they would receive, or how long they would take it ^[1].

Eligibility for this study is limited to adults who have both alcohol use disorder and overweight or obesity ^[1]. The listing does not state how many people have enrolled so far, how long recruitment will stay open, or whether other sites will be added ^[1].

What happens next

Recruitment is under way at the University of Southern California ^[1]. The estimated completion date for the study is August 2026 ^[1]. A date for posting results has not been disclosed ^[1], and it is not yet known when or whether the findings will appear in a medical journal.