Coronavirus Disease 2019 (Covid-19) Impact on Alcohol-related Liver Disease Patient Outcomes, Care and Alcohol Use

StatusActive, Not Recruiting
PhaseNot applicable
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Jan 31, 2026 → Feb 27, 2028
See other at-risk trials from University of California, San Francisco

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jan 31, 2026 to Feb 27, 2028 Show 4 more changesShow less
    • Study completion pushed from Feb 27, 2026 to Feb 27, 2028
    • Eligibility criteria expanded, about 9 words
    • Study description revised
    • Publications: details revised at 6 of 6 entries
  2. Re-verified, no change to tracked fieldsv7
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    • Eligibility criteria expanded, about 1 word
    v6
  4. Re-verified, no change to tracked fieldsv5
  5. Primary completion date: Jan 15, 2024 to Jan 31, 2026
    • Study completion date: Jan 15, 2024 to Feb 27, 2026
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Start date changed from estimate of Mar 15, 2022 to Feb 1, 2022
    v3
  2. Start date: Jan 15, 2022 to Mar 15, 2022v2 Show 4 more changesShow less
    • Secondary endpoints: details revised at 1 of 3 entries
    • Eligibility criteria expanded, about 1 word
    • Study description expanded, about 4 words
    • Study title expanded, about 3 words
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 disease receiving care in hepatology practices at three sites. Patients who meet eligibility criteria will be randomized to one of two study arms: 1) Stepped Alcohol Treatment (SAT) or, 2) Usual Care (UC). Participants will be randomized separately by site. SAT includes 3 sessions of motivational interviewing followed by referral to addiction medicine for patients who do not reduce unhealthy drinking. Trial outcome measures will be complete at 6 and 12 months following baseline enrollment.
Trial Details
NCT Number NCT05191446
Lead Sponsor University of California, San Francisco
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions
(from sponsor)		 Liver Diseases, Alcohol Use Disorder
Related terms Alcoholism, Liver Diseases
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov