Full-Avoidance vs. Permissive/Regulated Drinking & Outcomes On Fibrillation (FULL-PROOF)

December 19, 2025 updated by: University of California, San Francisco

Full-Avoidance vs. Permissive/Regulated Drinking & Outcomes On Fibrillation (FULL-PROOF)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a case-crossover randomized trial, where each participant will be instructed to avoid or not avoid drinking alcohol on randomly assigned days during a 14-day monitoring period. Participants will also wear an external ECG monitor, an alcohol monitor, a continuous glucose monitor, and a fitness tracker for up to two weeks while utilizing a mobile application to receive daily instructions/reminders on drinking and short surveys. The investigators will compare participant self-report of alcohol consumption, glucose monitoring, fitness levels, sleep health, and heart rhythm data in order to better understand the immediate relationship between drinking alcohol and heart rhythm. A total of 100 participants will be enrolled.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Medical Center at Mission Bay
        • Contact:
      • San Francisco, California, United States, 94143
        • Recruiting
        • UCSF Medical Center at Parnassus
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence or Absence of Discrete Atrial Fibrillation Episodes
Time Frame: 2 weeks
Participants will be wearing a continuously recording ECG monitor for two weeks. The primary outcome will be the presence (versus absence) of at least one AFib episode on randomly assigned drinking versus non-drinking days.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
As-Treated Relationships versus the Presence of AFib
Time Frame: 2 weeks
As-treated (whether alcohol was consumed or not according to real-time patient reports using the Zio patch button and/ or alcohol sensors) relationships versus the presence of AFib will be considered.
2 weeks
Daily Glucose Levels
Time Frame: 2 weeks
This will first be assessed according to intention-to-treat and then as-treated. Participants will be wearing a continuous glucose monitor that will record serum glucose levels. A secondary outcome will be difference in daily glucose levels due to alcohol consumption or avoidance during the monitoring period.
2 weeks
Step Counts
Time Frame: 2 weeks
This will first be assessed according to intention-to-treat and then as-treated. Participants will be wearing a fitness tracker that will record step counts. A secondary outcome will be difference in step counts due to alcohol consumption or avoidance during the monitoring period.
2 weeks
Sleep Duration
Time Frame: 2 weeks
This will first be assessed according to intention-to-treat and then as-treated. Participants will be wearing a fitness tracker that will record sleep duration. A secondary outcome will be difference in sleep duration due to alcohol consumption or avoidance during the monitoring period.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Gregory Marcus, MD, MAS, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

December 23, 2024

First Submitted That Met QC Criteria

December 23, 2024

First Posted (Actual)

December 31, 2024

Study Record Updates

Last Update Posted (Actual)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 19, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-41856
  • R01AA022222 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atrial Fibrillation (Paroxysmal)

Clinical Trials on Alcohol Consumption Randomized Instructions

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe