Recruiting

Full-Avoidance vs. Permissive

Sponsor:

UCLA

Code:

NCT06754176

Conditions

Atrial Fibrillation (AF)

Atrial Fibrillation (Paroxysmal)

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Alcohol Consumption Randomized Instructions

Study Details

Brief summary:

The goal of this study is to assess the short-term effects of minimal and moderate drinking on atrial fibrillation (AFib) episodes in a real-world population diagnosed with 'come-and-go'/paroxysmal AFib. The question it aims to answer is:

Is there a greater occurrence of AFib episodes when participants are allowed to consume alcohol according to random assignment?

Participants will:

  • Be given daily random assignments to avoid or not to avoid alcohol
  • Wear an adhesive electrocardiographic (ECG) heart monitor
  • Wear a wrist-worn fitness tracker
  • Wear an anklet transdermal alcohol monitor
  • Wear an adhesive glucose monitor
  • Complete morning and evening surveys daily

Participants may be compensated up to $50 for full completion of the study. This study can be done in-person or remote.

Conditions

Atrial Fibrillation (AF)

Atrial Fibrillation (Paroxysmal)

Study ID

NCT06754176

Start date

Apr 17, 2025

Status verified date

Dec, 2025

Completion date

Aug, 2029

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Comfortable reading and writing in English
  • Have a smartphone and willing and able to use the Eureka mobile application
  • Currently diagnosed with paroxysmal AFib without a plan to change their AFib management during the two-week monitoring period
  • At least one episode of AFib in the past month OR, in the judgement of a healthcare provider, could potentially have one episode of AF in the next month
  • Drank alcohol at least 1 day/week on average in the past month
  • Willing and able to be randomly assigned daily to avoid or not avoid drinking alcohol over a 2-week period
  • Willing and able to provide written informed consent

Exclusion Criteria

  • Only post-operative AFib
  • Greater than 40% ventricular pacing
  • History of alcohol addiction or abuse determined by self-reported history or AUDIT-C score
  • Intolerance to alcohol
  • History of liver disease
  • Currently incarcerated
  • Currently pregnant or trying to get pregnant

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Alcohol Non-Avoidance Case-Crossover Arm

On a given day of the 14-day study period, participants may be randomly assigned to not avoid consuming alcohol. All participants will be instructed that any alcohol consumed should not be more than 2 drinks in a 24 hour period for men and not more than 1 drink in a 24 hour period for women.

The frequency of randomization will be tailored to the baseline usual frequency of alcohol consumption: For example, those who drink an average of 4 days a week/don't drink 3 days a week will have their randomization programmed to assure an average of 7 non-drinking days over the two-week period. Participants will not receive the same randomization assignment more than two consecutive days in a row.

Participants will press a button on their continuously recording ECG monitor to time-stamp every alcohol drink consumed.

experimental: Alcohol Avoidance Case-Crossover Arm

On a given day of the 14-day study period, participants may be randomly assigned to avoid consuming alcohol.

The frequency of randomization will be tailored to the baseline usual frequency of alcohol consumption: For example, those who drink an average of 4 days a week/don't drink 3 days a week will have their randomization programmed to assure an average of 7 non-drinking days over the two-week period. Participants will not receive the same randomization assignment more than two consecutive days in a row.

Interventions

Alcohol Consumption Randomized Instructions

Alcohol Avoidance: In this intervention assignment, participants will be instructed to avoid drinking alcohol for this day.

Alcohol Non-Avoidance: In this intervention assignment, participants will be allowed to drink alcohol for this day.

Primary outcome measure

  • Presence or Absence of Discrete Atrial Fibrillation Episodes [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Gregory M Marcus, MD, MAS

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

Hannah H Oo, BS

415-476-4999hannah.oo@ucsf.edu

Locations

UCSF Medical Center at Parnassus

Recruiting

San Francisco, California, United States, 94143

Contacts

Study Principal Investigator

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

UCSF Medical Center at Mission Bay

Recruiting

San Francisco, California, United States, 94158

Contacts

Study Principal Investigator

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

More Information

Sponsor

University of California, San Francisco

Last update posted

Dec 23, 2025

Last verified

Dec, 2025

Keywords

  • Alcohol
  • Drinking
  • Mediterranean Drinking Pattern
  • Atrial Fibrillation
  • AFib
  • AF
  • Heart Rhythm

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 2025-12-23.