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NCT06754176Recruiting

Full-Avoidance vs. Permissive/Regulated Drinking & Outcomes On Fibrillation

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

Source: ClinicalTrials.gov · Last updated 23 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
23 Dec 2024
Start date
17 Apr 2025
Primary completion date
Dec 2026
Lead sponsor
University of California, San Francisco
NCT number
NCT06754176

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 17 Apr 2025 to the primary completion date, Dec 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of alcohol addiction or abuse determined by self-reported history or AUDIT-C score
  • History of liver disease

Other

  • Only post-operative AFib
  • Greater than 40% ventricular pacing
  • Intolerance to alcohol
  • Currently incarcerated
  • Currently pregnant or trying to get pregnant

Who the study is looking for

  • 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

Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UCSF Medical Center at Parnassus
Coordinator of this site? Confirm its status
San FranciscoUnited StatesRecruiting
UCSF Medical Center at Mission Bay
Coordinator of this site? Confirm its status
San FranciscoUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.