NCT05191446

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 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 Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2026

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

4 years

First QC Date

January 11, 2022

Last Update Submit

September 12, 2025

Conditions

Liver DiseasesAlcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in alcohol use

    Less than moderate alcohol use in the prior 30 days at month 6 follow-up. Alcohol use survey questions will assess usual drinking frequency (days per week) and typical number of standard drinks consumed, in order to compute average number of drinks per week; and number of days of hazardous drinking (5+ drinks for men and, and 4+ drinks per women) in the past 30 days, using the Timeline Followback Method.

    6 months after enrollment

Secondary Outcomes (3)

  • Alcohol use cessation

    6 and 12 months after enrollment

  • Drinks per week

    6 and 12 months after enrollment

  • Liver-related outcomes

    6 and 12 months after enrollment

Study Arms (2)

Stepped alcohol intervention (SAT) to reduce unhealthy alcohol use

EXPERIMENTAL

For participants randomized to SAT, consistent with stepped care, treatment will begin with lower intensity services that are stepped up, if necessary, at a predefined time point. Step 1 consists of three motivational interviewing (MI)sessions delivered every 2 weeks. At the 3-month assessment, those with non-response to MI, defined as continued unhealthy alcohol use in the prior 14 days, will be referred to on site physician managed addiction specialty services (Step 2) for higher intensity services.

Behavioral: Stepped alcohol intervention (SAT) to reduce unhealthy alcohol use

Usual Care (UC)

ACTIVE COMPARATOR

UC participants will receive their usual services in hepatology. They will also be given publicly available patient education materials regarding risk associated with unhealthy drinking (mail/email or in-person if desired) and will be asked to follow up with their physician should they have questions about information provided in the handouts. UC participants' hepatology provider will be notified if AUDIT-C scores are greater than 3 at baseline. All UC participants will have access to alcohol and other substance use treatment available to patients at their respective sites.

Other: Usual Care (UC)

Interventions

Stepped alcohol intervention (SAT) to reduce unhealthy alcohol useBEHAVIORAL

Step 1 includes three sessions of motivational interviewing (MI). MI will consist of three video (Zoom) or telephone sessions: an initial 45-minute session, followed by two 20-minute sessions. Treatment is based on "Motivational Interviewing" by Miller and Rollnick, and includes exploring ambivalence about change, reflective listening, expressing empathy, and discussion about change. To support increased motivation to reduce drinking, discussion will center on effects of hazardous drinking on liver disease. Step 2 includes referral to addiction medicine for participants who do not reduce unhealthy alcohol use or requested by patient. Specialty addiction services include both direct treatment and coordination of addiction care. After an evaluation, the addiction medicine physician may recommend pharmacotherapy (in consultation with hepatology provider if indicated), and/or referral to intensive outpatient, or residential level of care depending on clinical judgement.

Stepped alcohol intervention (SAT) to reduce unhealthy alcohol use
Usual Care (UC)OTHER

UC participants will receive their usual services in hepatology. They will also be given publicly available patient education materials regarding risk associated with unhealthy drinking (mail/email or in-person if desired) and will be asked to follow up with their physician should they have questions about information provided in the handouts. UC participants' hepatology provider will be notified if AUDIT-C scores are greater than 3 at baseline. All UC participants will have access to alcohol and other substance use treatment available to patients at their respective sites.

Usual Care (UC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of california San Francisco

San Francisco, California, 94110, United States

Location

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (6)

  • Satre DD, Dasarathy D, Batki SL, Ostacher MJ, Snyder HR, Hua W, Parekh P, Shui AM, Cheung R, Monto A, Wong RJ, Chen JY, Liao M, Tana M, Chen PH, Haight CG, Fakadej T, Khalili M. Factors Associated With Motivation to Reduce Alcohol Use Among Patients With Chronic Liver Disease. Aliment Pharmacol Ther. 2025 Feb;61(3):481-490. doi: 10.1111/apt.18387. Epub 2024 Nov 11.

    PMID: 39523996RESULT

  • Luk JW, Ha NB, Shui AM, Snyder HR, Batki SL, Ostacher MJ, Monto A, Wong RJ, Cheung R, Parekh P, Hua W, Tompkins DA, Fakadej T, Haight CG, Liao M, Khalili M, Satre DD. Demographic and clinical characteristics associated with utilization of alcohol use disorder treatment in a multicenter study of patients with alcohol-associated cirrhosis. Alcohol Clin Exp Res (Hoboken). 2025 Jan;49(1):244-255. doi: 10.1111/acer.15500. Epub 2024 Dec 4.

    PMID: 39632077RESULT

  • Wong RJ, Yang Z, Ostacher M, Zhang W, Satre D, Monto A, Khalili M, Singal AK, Cheung R. Alcohol Use Patterns During and After the COVID-19 Pandemic Among Veterans in the United States. Am J Med. 2024 Mar;137(3):236-239.e2. doi: 10.1016/j.amjmed.2023.11.013. Epub 2023 Dec 3.

    PMID: 38052382RESULT

  • Athavale P, Wong RJ, Satre DD, Monto A, Cheung R, Chen JY, Batki SL, Ostacher MJ, Snyder HR, Widiarto BD, Oh SY, Liao M, Viviani AML, Khalili M. Telehepatology Use and Satisfaction Among Vulnerable Cirrhosis Patients Across Three Healthcare Systems in the Coronavirus Disease Pandemic Era. Gastro Hep Adv. 2023 Nov 20;3(2):201-209. doi: 10.1016/j.gastha.2023.11.006. eCollection 2024.

    PMID: 39129958RESULT

  • Luk JW, Satre DD, Cheung R, Wong RJ, Monto A, Chen JY, Batki SL, Ostacher MJ, Snyder HR, Shui AM, Liao M, Haight CG, Khalili M. Problematic alcohol use and its impact on liver disease quality of life in a multicenter study of patients with cirrhosis. Hepatol Commun. 2024 Feb 3;8(2):e0379. doi: 10.1097/HC9.0000000000000379. eCollection 2024 Feb 1.

    PMID: 38315141RESULT

  • Kim RG, Patel S, Satre DD, Shumway M, Chen JY, Magee C, Wong RJ, Monto A, Cheung R, Khalili M. Telehepatology Satisfaction Is Associated with Ethnicity: The Real-World Experience of a Vulnerable Population with Fatty Liver Disease. Dig Dis Sci. 2024 Mar;69(3):732-742. doi: 10.1007/s10620-023-08222-7. Epub 2024 Jan 13.

    PMID: 38217682RESULT

MeSH Terms

Conditions

Liver DiseasesAlcoholism

Interventions

EthanolMethodsdiamine N-acetyltransferase

Condition Hierarchy (Ancestors)

Digestive System DiseasesAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsInvestigative Techniques

Study Officials

  • Mandana Khalili, M.D.

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Research assistants completing follow up interviews with participants will be blinded to study condition.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized trial with patients assigned to an experimental condition or to usual care.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2022

First Posted

January 13, 2022

Study Start

February 1, 2022

Primary Completion

January 31, 2026

Study Completion

February 27, 2026

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

The study will comply with NOT-AA-19-020, "Notice of NIAAA Data-Sharing Policy for Human Subjects Grants Research Funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA)." NIAAA requires studies that include human subjects to submit de-identified data into the NIAAA data repository (NIAAADA), a NIAAA data repository hosted and managed by the National Institute of Mental Health (NIMH) Data Archive (NDA), in order to enable widespread data sharing. Key measurement domains include quality of life, patient satisfaction with care, use of telemedicine, health literacy measures, alcohol use, anxiety, depression, and use of health services. The investigators will obtain Informed Consent that allows for broad sharing of the research subjects' de-identified data and will follow all other necessary procedures as described in our Data Sharing and Archiving Plan.

Shared Documents
STUDY PROTOCOL
Time Frame
The study team will submit data on or before the NDA submission due dates (April 1 and October 1 each year) in accordance with the applicable Data Sharing Terms and Conditions of award. The team will perform quality assurance (QA)/quality control (QC) checks on data within 4 months after the submission due dates and address any issues identified by the NDA. The study team will run the required NIAAADA data validation tool at least one time per month once data collection begins. Duration of availability will follow NIAAADA criteria.
Access Criteria
Access criteria will follow NIAAADA guidelines. The study team will Share data in accordance with the default NIAAADA data sharing schedule in accordance with the applicable Data Sharing Terms and Conditions of award.

Locations

US(2)