Status:
ACTIVE_NOT_RECRUITING
Coronavirus Disease 2019 (Covid-19) Impact on Alcohol-related Liver Disease Patient Outcomes, Care and Alcohol Use
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Liver Diseases
Alcohol Use Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study consists of a randomized controlled trial evaluating the efficacy and feasibility of a stepped alcohol treatment using telemedicine on unhealthy alcohol use in patients with chronic liver di...
Detailed Description
Background/Rationale: Unhealthy alcohol use is consumption of alcohol at more than the "moderate" levels of up to 1 drink per day (7/week) for women and up to 2 drinks per day (14/week) for men, as de...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Men and women age ≥ 18 years.
- Diagnosis of chronic liver disease (CLD).
- Unhealthy alcohol use, defined as more than moderate amount of alcohol use within the prior 30 days by National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria defined as on average more than 1 drink/day (7 drinks per week) for women and more than 2 drinks per day (14 drinks per week) for men, or on average at least one heavy drinking day (4+ drinks in a day for women and 5+ for men) per week in the prior 30 days. A standard drink is \~14 g of alcohol.
- Ability to access a telephone or a digital device (i.e., computer, tablet or smart phone).
- Exclusion criteria:
- Severe medical or psychiatric conditions or evidence of acute alcohol intoxication preventing participation in the study
- Are currently enrolled in formal treatment for unhealthy alcohol use, excluding self or mutual-help groups (e.g., Alcoholics Anonymous).
- Women who are pregnant or breastfeeding or unwilling to use birth control.
- Language preference other than English, Spanish or Chinese.
- Unwilling or unable to provide informed consent.
Exclusion
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 27 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05191446
Start Date
February 1 2022
End Date
February 27 2026
Last Update
September 18 2025
Active Locations (2)
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1
University of california San Francisco
San Francisco, California, United States, 94110
2
Zuckerberg San Francisco General Hospital
San Francisco, California, United States, 94110