Liver DiseasesNCT05191446
Coronavirus Disease 2019 (Covid-19) Impact on Alcohol-related Liver Disease Patient Outcomes, Care and Alcohol Use
A study testing Stepped alcohol intervention (SAT) to reduce unhealthy alcohol use in people with Liver Diseases and Alcohol Use Disorder, run by University of California, San Francisco at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases, Alcohol Use Disorder
- What is being tested?
- Stepped alcohol intervention (SAT) to reduce unhealthy alcohol use
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2022to 27 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of california San Francisco
San Francisco, California, 94110
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: Impact of the Coronavirus 2019 (COVID-19) Pandemic on Patient Outcomes, Telehealth Care Delivery, and Treatment for Unhealthy Alcohol Use in Vulnerable Patients With Advanced Liver Disease Across Two Healthcare Systems
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.
Read the 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 defined by NIAAA. Unhealthy alcohol use is prevalent in chronic liver disease (CLD), and for many patients no level of alcohol could be considered safe. Guidelines recommend integrated multidisciplinary care, but evidence-based strategies to address alcohol use beyond brief counseling are rarely provided in hepatology practices. A recent study showed that most veterans with cirrhosis and coexisting AUD do not receive behavioral treatment or pharmacotherapy for AUD. Similarly, in a study of cirrhosis patients [~70% alcohol-associated liver disease (ALD)] hospitalized at 4 safety net hospitals, less than half reported abstinence from alcohol, while 39% reported daily alcohol use, and alcoholic hepatitis accounted for the highest in-hospital mortality compared to other comorbidities. The investigators are focusing on these important outcomes in this study. Current guidelines recommend that brief intervention, pharmacotherapy, and referral to treatment should be offered to patients with ALD including those with alcohol use disorder (AUD) or advanced CLD of any etiology who drink alcohol at more than moderate amounts. Our approach follows these guidelines.
Overall approach: The investigators will enroll a total of 180 patients (90 assigned to stepped care, 90 to usual care) with liver disease and alcohol use; 60 patients will be recruited from each of the three study sites (two Veterans Administrations Healthcare System sites in Palo Alto and San Francisco as well as a safety net public clinic in San Francisco, CA). This intent-to-treat outcome study will include all patients recruited, whether or not they complete the interventions.
Recruitment: Hepatology practices at all three sites routinely screen patients for alcohol use. Eligible patients will be identified using the electronic medical record and, following permission from their provider, patients will be contacted about the study. Patients may also be referred directly by their hepatology providers. Interested patients who meet all eligibility criteria will be consented to participate in the study. The investigators will include English and Spanish speakers using bicultural and bilingual clinical research coordinators. Following enrollment, participants will have baseline, 3-, 6-, and 12-month assessments. Participants will be offered $50 for completing the baseline, 3-, and 6-month, and $100 for 12-month assessments.
Baseline assessment: At baseline, patient demographics (age, sex, race/ethnicity, income, education, insurance), medical history, medications, etiology of CLD, presence of cirrhosis or hepatic decompensation, history of illicit drugs, laboratory tests of liver function and COVID-19 will be captured using the electronic medical record. Measures of alcohol use will be performed using validated measures. Patients will then undergo randomization.
Randomization to study arms: Patients who meet study criteria will be randomized to one of two study arms: 1) Stepped Alcohol Treatment (SAT) or, 2) Usual Care (UC). See "Arms and Interventions" section for details.
Follow-up Assessments: A research staff member not participating in patient care will conduct follow-up interviews. He/she will be blinded to participants' treatment condition. Participants will be contacted by telephone at 3, 6 and 12 months to complete the measures. Patient reporting via telephone follow-up has been reliable in prior studies but a biomarker of alcohol use will also be performed to validate reports of alcohol abstinence
Statistical analysis: Repeated measures analyses will be conducted within a generalized linear mixed model (GLMM) framework. These models accommodate the range of continuous, count, and discrete outcomes that will be measured. Analyses will include treatment condition (SAT vs UC) as a between-subjects effect. Time (baseline, 3-month, 6-month, and 12-months) will be a repeated effect and the treatment x time interaction will be examined. Analyses will account for clustering of patients within study site.
Sample size: Sample size was determined using data from prior studies of MI and stepped care interventions for unhealthy alcohol use in individuals with liver disease and other populations, for the primary outcome (less than moderate alcohol use) and the secondary outcome of drinks per week.
Anticipated results: The investigators anticipate that SAT participants will be more likely than UC to reduce or be abstinent from alcohol use at the 3-, 6- and 12-month follow-up. The investigators also anticipate that SAT participants will have better clinical outcomes (less new or worsening clinical decompensation or hospitalizations) than controls at follow-up. The investigators will also explore COVID-19 related outcomes in both arms, e.g., infection rates, hospitalization and clinical outcomes.
- Conditions
- Liver Diseases, Alcohol Use Disorder
- Being tested
- Stepped alcohol intervention (SAT) to reduce unhealthy alcohol use, Usual Care (UC)
- Medical subject headings
- Liver Diseases, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stepped alcohol intervention (SAT) to reduce unhealthy alcohol useBehavioural
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual Care (UC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after enrollment
Secondary outcomes (3)
Alcohol use cessation
Alcohol use will be assessed at 6 months and 12 months following enrollment, using the Timeline Followback Method.
Measured: 6 and 12 months after enrollment
Drinks per week
Alcohol use will be assessed at 6 months and 12 months following enrollment, using the Timeline Followback Method.
Measured: 6 and 12 months after enrollment
Liver-related outcomes
Worsening liver function tests, new or worsening hepatic decompensation or new diagnosis of cirrhosis in those without advanced CLD, number of hospitalizations, Child-Pugh (A, B, and C) and Model of End stage Liver Disease (MELD) labs will be captured using electronic medical record data.
Measured: 6 and 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Feb 2022
- Primary completion27 Feb 2028 (estimated)
- Study completion27 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized trial with patients assigned to an experimental condition or to usual care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Mandana Khalili, M.D., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191446
- Sponsor's protocol ID
- 20-33076
- Other IDs
- R01AA029312
- Status last verified
- Oct 2026
- First submitted
- 11 Jan 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39523996Luk 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.
PubMed 39632077Wong 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.
PubMed 38052382Athavale 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.
PubMed 39129958Luk 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.
PubMed 38315141Kim 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.
PubMed 38217682
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Coronavirus 2019 (COVID-19) Pandemic on Patient Outcomes, Telehealth Care Delivery, and Treatment for Unhealthy Alcohol Use in Vulnerable Patients With Advanced Liver Disease Across Two Healthcare Systems
- ClinicalTrials.gov ID
- NCT05191446
- Acronym / sponsor ID
- 20-33076
- Conditions
- Liver Diseases, Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 27 Feb 2028 (estimated)
- Study completion
- 27 Feb 2028 (estimated)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 defined by NIAAA. Unhealthy alcohol use is prevalent in chronic liver disease (CLD), and for many patients no level of alcohol could be considered safe. Guidelines recommend integrated multidisciplinary care, but evidence-based strategies to address alcohol use beyond brief counseling are rarely provided in hepatology practices. A recent study showed that most veterans with cirrhosis and coexisting AUD do not receive behavioral treatment or pharmacotherapy for AUD. Similarly, in a study of cirrhosis patients [~70% alcohol-associated liver disease (ALD)] hospitalized at 4 safety net hospitals, less than half reported abstinence from alcohol, while 39% reported daily alcohol use, and alcoholic hepatitis accounted for the highest in-hospital mortality compared to other comorbidities. The investigators are focusing on these important outcomes in this study. Current guidelines recommend that brief intervention, pharmacotherapy, and referral to treatment should be offered to patients with ALD including those with alcohol use disorder (AUD) or advanced CLD of any etiology who drink alcohol at more than moderate amounts. Our approach follows these guidelines.
Overall approach: The investigators will enroll a total of 180 patients (90 assigned to stepped care, 90 to usual care) with liver disease and alcohol use; 60 patients will be recruited from each of the three study sites (two Veterans Administrations Healthcare System sites in Palo Alto and San Francisco as well as a safety net public clinic in San Francisco, CA). This intent-to-treat outcome study will include all patients recruited, whether or not they complete the interventions.
Recruitment: Hepatology practices at all three sites routinely screen patients for alcohol use. Eligible patients will be identified using the electronic medical record and, following permission from their provider, patients will be contacted about the study. Patients may also be referred directly by their hepatology providers. Interested patients who meet all eligibility criteria will be consented to participate in the study. The investigators will include English and Spanish speakers using bicultural and bilingual clinical research coordinators. Following enrollment, participants will have baseline, 3-, 6-, and 12-month assessments. Participants will be offered $50 for completing the baseline, 3-, and 6-month, and $100 for 12-month assessments.
Baseline assessment: At baseline, patient demographics (age, sex, race/ethnicity, income, education, insurance), medical history, medications, etiology of CLD, presence of cirrhosis or hepatic decompensation, history of illicit drugs, laboratory tests of liver function and COVID-19 will be captured using the electronic medical record. Measures of alcohol use will be performed using validated measures. Patients will then undergo randomization.
Randomization to study arms: Patients who meet study criteria will be randomized to one of two study arms: 1) Stepped Alcohol Treatment (SAT) or, 2) Usual Care (UC). See "Arms and Interventions" section for details.
Follow-up Assessments: A research staff member not participating in patient care will conduct follow-up interviews. He/she will be blinded to participants' treatment condition. Participants will be contacted by telephone at 3, 6 and 12 months to complete the measures. Patient reporting via telephone follow-up has been reliable in prior studies but a biomarker of alcohol use will also be performed to validate reports of alcohol abstinence
Statistical analysis: Repeated measures analyses will be conducted within a generalized linear mixed model (GLMM) framework. These models accommodate the range of continuous, count, and discrete outcomes that will be measured. Analyses will include treatment condition (SAT vs UC) as a between-subjects effect. Time (baseline, 3-month, 6-month, and 12-months) will be a repeated effect and the treatment x time interaction will be examined. Analyses will account for clustering of patients within study site.
Sample size: Sample size was determined using data from prior studies of MI and stepped care interventions for unhealthy alcohol use in individuals with liver disease and other populations, for the primary outcome (less than moderate alcohol use) and the secondary outcome of drinks per week.
Anticipated results: The investigators anticipate that SAT participants will be more likely than UC to reduce or be abstinent from alcohol use at the 3-, 6- and 12-month follow-up. The investigators also anticipate that SAT participants will have better clinical outcomes (less new or worsening clinical decompensation or hospitalizations) than controls at follow-up. The investigators will also explore COVID-19 related outcomes in both arms, e.g., infection rates, hospitalization and clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized trial with patients assigned to an experimental condition or to usual care.
| Arm | Type | Receives |
|---|---|---|
| Stepped alcohol intervention (SAT) to reduce unhealthy alcohol use | Experimental | Behavioral: Stepped alcohol intervention (SAT) to reduce unhealthy alcohol useFor 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. |
| Usual Care (UC) | Active comparator | Other: Usual Care (UC)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stepped alcohol intervention (SAT) to reduce unhealthy alcohol useStep 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. | Behavioural | Stepped alcohol intervention (SAT) to reduce unhealthy alcohol use |
| Usual Care (UC)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) |
Primary outcome
Change in alcohol use
Time frame: 6 months after enrollment
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.
3 secondary outcomes
Alcohol use cessation
Time frame: 6 and 12 months after enrollment
Drinks per week
Time frame: 6 and 12 months after enrollment
Liver-related outcomes
Time frame: 6 and 12 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Results publication: PubMed 39523996Satre 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.
- Results publication: PubMed 39632077Luk 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.
- Results publication: PubMed 38052382Wong 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.
- Results publication: PubMed 39129958Athavale 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.
- Results publication: PubMed 38315141Luk 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.
- Results publication: PubMed 38217682Kim 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.
- Individual participant dataSharing planned: Yes. 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.
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Hepatitis D
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mandana Khalili, M.D. principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stepped alcohol intervention (SAT) to reduce unhealthy alcohol use in people with Liver Diseases and Alcohol Use Disorder, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in alcohol use (time frame: 6 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05191446, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.