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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06754176
Status
Recruiting
Apply to this trial

Conditions

  • Atrial Fibrillation (AF)
  • Atrial Fibrillation (Paroxysmal)

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Alcohol Consumption Randomized Instructions — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Apr 17, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Aug 31, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UCSF Medical Center at Mission BaySan FranciscoCalifornia94158
Study Principal Investigator
[email protected]
415-476-5706
UCSF Medical Center at ParnassusSan FranciscoCalifornia94143
Study Principal Investigator
[email protected]
415-476-5706

Find similar trials in San Francisco, CA

By research site
UCSF Medical Center at Mission Bay· San Francisco, CAUCSF Medical Center at Parnassus· San Francisco, CA

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