Recruiting

DRINK-LESS

Sponsor:

UCLA

Code:

NCT06995391

Conditions

Atrial Fibrillation (AF)

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Contemporary Guideline-Adherence

Alcohol Abstinence

Study Details

Brief summary:

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.

Conditions

Atrial Fibrillation (AF)

Study ID

NCT06995391

Start date

Apr 20, 2025

Status verified date

Jul, 2025

Completion date

Mar 1, 2030

Anticipated

Primary completion date

Mar 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Are age 21 years or older
  • Have a smartphone
  • Are able to use the Eureka mobile application
  • Have a history of paroxysmal or persistent atrial fibrillation (AF)
  • Have consumed alcohol at least once per month on average in the past year
  • Willing to receive messaging encouraging alcohol abstinence

Exclusion Criteria:

  • Non-english speaker
  • Currently pregnant or trying to get pregnant
  • A healthcare professional's instruction to avoid alcohol (for any reason)
  • Currently incarcerated
  • Permanent AF (meaning a medical determination has been made that sinus rhythm would definitely never be pursued in this patient)
  • Are unable to read or sign to provide informed consent

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Contemporary Guideline-Adherence

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.

experimental: Alcohol Abstinence

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.

Interventions

Contemporary Guideline-Adherence

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 Abstinence

Participants randomized to Alcohol Abstinence will receive weekly app and text-based messaging encouraging avoiding all alcohol consumption.

Primary outcome measure

  • Change in atrial fibrillation severity at one year [ Time Frame: From baseline to one year of study participation. ]

Central Contacts and Locations

Central contacts

Gregory M Marcus, MD, MAS

415-476-5706greg.marcus@ucsf.edu

Gabrielle C Montenegro, BA

415-502-3053gabby.montenegro2@ucsf.edu

Locations

UCSF Medical Center at Parnassus

Recruiting

San Francisco, California, United States, 94143

Contacts

Gregory M Marcus, MD, MAS

415-476-5706greg.marcus@ucsf.edu

Isabella Peña, BA

415-502-3053bella.pena@ucsf.edu

Principal Investigator:

Gregory M Marcus, MD, MAS

More Information

Sponsor

University of California, San Francisco

Last update posted

Jul 31, 2025

Last verified

Jul, 2025

Keywords

  • Atrial Fibrillation
  • AFib
  • Alcohol
  • Mediterranean Drinking Pattern
  • Red wine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2025-07-31.