NCT06754176 · University of California, San Francisco
Full-Avoidance vs. Permissive/Regulated Drinking & Outcomes On Fibrillation
(FULL-PROOF)
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- San Francisco, California
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 23, 2025 · Source of record for eligibility and locations