Alcohol Abstinence for Atrial Fibrillation

(DRINK-LESS Trial)

Overseen By Gabrielle C Montenegro, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Non-english speaker, Pregnant, Incarcerated, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

1000 Participants Needed

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

Willing to receive messaging encouraging alcohol abstinence

Have consumed alcohol at least once per month on average in the past year

Have a smartphone

Exclusion Criteria

A healthcare professional's instruction to avoid alcohol (for any reason)

Are unable to read or sign to provide informed consent

Non-english speaker

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

52 weeks

Weekly digital interactions

Follow-up

Participants are monitored for changes in atrial fibrillation severity and burden, with assessments including surveys and optional device data sharing.

4 weeks

Treatment Details

Interventions

• Alcohol Abstinence
• Contemporary Guideline-Adherence

Trial Overview The DRINK-LESS trial is testing whether completely stopping alcohol use or adhering to moderate consumption following the Mediterranean diet guidelines affects AF severity differently. It's a controlled study where participants are randomly assigned to one of two digital health interventions.

Participant Groups

Group I: Contemporary Guideline-Adherence Experimental Treatment 1 Intervention

Participants randomized to Contemporary Guideline-Adherence will receive weekly app and text-based messaging encouraging them not to exceed guideline-directed amounts of alcohol, as well as messaging explaining that abstinence is acceptable and may be the best way to avoid AF and that, if a participant decides to consume alcohol, a Mediterranean drinking pattern may be the most healthy. Alcohol consumption (or abstinence) and AF episodes and severity will be assessed by serial surveys. Abstinence will also be objectively assessed via urine ethyl glucuronide (EtG) tests and a blood test for phosphatidylethanol (PEth) in randomly selected participants.

Group II: Alcohol Abstinence Experimental Treatment 1 Intervention

Participants randomized to Alcohol Abstinence will receive weekly app and text-based messaging encouraging avoidance of all alcohol consumption. Those assigned to this arm will also have the option to opt-in or decline to participate in additional messaging and surveys discouraging the purchase of alcohol triggered by visits to establishments that sell alcohol (bars and liquor stores) for the first month of the study. Alcohol consumption (or abstinence) and AF episodes and severity will be assessed by serial surveys. Abstinence will also be objectively assessed via urine ethyl glucuronide (EtG) tests and a blood test for phosphatidylethanol (PEth) in randomly selected participants.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+