Alcohol Abstinence for Atrial Fibrillation
(DRINK-LESS Trial)
Trial Summary
What is the purpose of this trial?
Per the 2021 National Survey on Drug Use and Health administered by the U.S. Department of Health and Human Services, 85% of all American adults consume alcohol. Atrial fibrillation (AF) is the most common arrhythmia, affecting more than 10 million individuals in U.S., comprising 4.5% of the adult population. Although alcohol abstinence clearly reduces AF in heavy drinkers, observational data comparing the health effects of limited consumption versus abstention are conflicting.The Mediterranean diet is one of the few that has demonstrated clear cardiovascular benefits in a randomized study-this diet allows for the consumption of red wine (or high polyphenol/ low alcohol alcohol), generally not more than one drink in 24 hours, with meals, avoiding spirits and binge drinking. The effect of the "Mediterranean drinking pattern" on AF risk compared to alcohol abstinence remains unknown.This single center, randomized, controlled trial aims to compare the effects of a digital health intervention to encourage durable alcohol abstinence versus allowing guideline-adherent moderate alcohol consumption on AF severity. The knowledge gained from this study may be used to determine optimal thresholds for alcohol use among AF patients.
Research Team
Gregory M Marcus, MD, MAS
Principal Investigator
University of California, San Francisco
Eligibility Criteria
This trial is for U.S. adults with atrial fibrillation (AF), the most common heart rhythm disorder. Participants should be current alcohol consumers, willing to either abstain from alcohol or follow a Mediterranean drinking pattern as per study assignment.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomly assigned to one of two digital health interventions for one year, receiving weekly app and text-based messaging regarding alcohol consumption.
Follow-up
Participants are monitored for changes in atrial fibrillation severity and burden, with assessments including surveys and optional device data sharing.
Treatment Details
Interventions
- Alcohol Abstinence
- Contemporary Guideline-Adherence
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator