Stepped Alcohol Intervention for Alcohol-related Liver Disease

Recruiting at 1 trial location

Overseen By Mandana Khalili, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Severe medical, Psychiatric, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 3 months

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the Stepped Alcohol Intervention safe for humans?

The research suggests that stepped alcohol interventions, including brief motivational interviews and low-intensity interventions, are generally safe for humans. These interventions have been used in various settings, such as colleges, and have shown high participant satisfaction and retention rates, indicating they are well-tolerated. ^{1 2 3 4 5}

How is the Stepped Alcohol Intervention treatment different from other treatments for alcohol-related liver disease?

The Stepped Alcohol Intervention (SAT) is unique because it combines motivational interviewing, a type of counseling that helps people find the motivation to change their behavior, with a stepped approach that adjusts the intensity of treatment based on the patient's progress. This personalized and flexible method contrasts with standard treatments that often focus solely on abstinence or use a fixed treatment plan. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Stepped Alcohol Intervention for Alcohol-related Liver Disease?

Research shows that motivational enhancement therapy (MET), a component of the Stepped Alcohol Intervention, significantly reduces alcohol use in patients with alcohol-related liver disease. Additionally, integrated treatments combining medical and psychosocial management, like the Stepped Alcohol Intervention, have shown promising results in improving outcomes for these patients. ^{6 11 12 13 14}

Who Is on the Research Team?

Mandana Khalili, M.D.

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic liver disease who drink more alcohol than recommended: over 7 drinks per week for women and 14 for men, or at least one heavy drinking day weekly. They must be able to use a phone or digital device but can't join if they're in formal alcohol treatment, pregnant/breastfeeding without birth control, non-English/Spanish speakers, unable to consent, or have severe medical/psychiatric issues.

Inclusion Criteria

I have been diagnosed with chronic liver disease.

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

I can use a phone or digital device like a computer, tablet, or smartphone.

Exclusion Criteria

I prefer to communicate in a language other than English or Spanish.

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessment of patient demographics, medical history, and alcohol use measures

1 week

1 visit (in-person or virtual)

Treatment

Participants receive either Stepped Alcohol Treatment (SAT) or Usual Care (UC). SAT includes motivational interviewing sessions and potential referral to addiction services.

3 months

3 visits (virtual or in-person for SAT)

Follow-up

Participants are monitored for changes in alcohol use and liver-related outcomes at 3, 6, and 12 months

12 months

3 visits (telephone follow-up)

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The study tests a Stepped Alcohol Treatment (SAT) using telemedicine against Usual Care (UC) to see if it helps reduce unhealthy drinking in liver disease patients. SAT involves motivational interviews and possible addiction medicine referrals. Participants are randomly assigned to either group and assessed after 6 and 12 months.

How Is the Trial Designed?

Group I: Stepped alcohol intervention (SAT) to reduce unhealthy alcohol use Experimental Treatment 1 Intervention

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.

Group II: Usual Care (UC) Active Control 1 Intervention

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 Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

Psychosocial interventions, particularly Motivational Enhancement Therapy (MET), have shown significant effectiveness in reducing alcohol consumption among patients with alcohol use disorder and alcohol-related liver disease, based on a systematic review of 10 randomized controlled trials involving 1519 participants.

Abstinence was notably achieved through peer support and integrated approaches combining medical and psychosocial management, indicating that a comprehensive treatment strategy may enhance recovery outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of psychosocial interventions to reduce alcohol use in comorbid alcohol use disorder and alcohol-related liver disease: a systematic review of randomized controlled trials. Hemrage, S., Brobbin, E., Deluca, P., et al.[2023]

Alcohol use disorder (AUD) treatment is essential for improving outcomes in patients with alcohol-associated liver disease (ALD), as it can significantly reduce mortality rates and enhance overall care.

Effective AUD care involves a three-step process: detecting alcohol use, diagnosing AUD, and referring patients to appropriate treatment, which can include various therapeutic modalities and requires collaboration between addiction specialists and liver disease providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of alcohol use disorder in patients with chronic liver disease. Mellinger, JL., Fernandez, AC., Winder, GS.[2023]

Motivational enhancement therapy (MET) significantly increased the percentage of days abstinent from alcohol in patients with hepatitis C and alcohol use disorder, rising from about 35% at baseline to over 73% after 6 months, compared to a smaller increase in the control group.

The study involved 139 participants and showed a moderate effect size (0.45) for MET, indicating its efficacy in promoting abstinence, although there were no significant differences in the number of drinks consumed per week between the MET and control groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of motivational enhancement therapy on alcohol use disorders in patients with chronic hepatitis C: a randomized controlled trial. Dieperink, E., Fuller, B., Isenhart, C., et al.[2016]

In a study of 136 patients with alcohol-associated liver disease (ALD) followed for a median of 1 year, 17% relapsed, with those who relapsed more likely to continue drinking despite liver disease and less likely to have received a transplant.

The study identified that insight into alcohol-use disorder (measured by the Hanil Alcohol Insight Scale) and social support at home (measured by the Community Assessment Inventory Scale) were predictive of relapse, highlighting the potential for targeted interventions to reduce relapse risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of Quantifiable Predictors of Relapse in Patients with Alcohol-Associated Liver Disease. Shen, NT., Kaplan, A., Fahoum, K., et al.[2023]

A study involving 225 college students showed that a Brief Motivational Interview (BMI) led to greater help-seeking and the use of strategies to moderate drinking compared to a computer-delivered intervention.

At the 12-month follow-up, BMI participants reported more frequent drinking, while those in the computer intervention consumed more drinks per occasion, indicating that while BMI may encourage positive behaviors initially, it did not lead to long-term reductions in alcohol consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of counselor vs. computer-delivered intervention with mandated college students. Barnett, NP., Murphy, JG., Colby, SM., et al.[2018]

A study involving college students mandated to a substance use prevention program showed that those who received brief motivational interviews (BMI) reported fewer alcohol-related problems compared to those who attended an alcohol education session, with assessments at 3 and 6 months.

While both groups showed trends toward reduced binge drinking episodes and lower typical blood alcohol levels, the BMI approach was more effective in addressing alcohol issues among students referred for violations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two brief alcohol interventions for mandated college students. Borsari, B., Carey, KB.[2018]

Innovative low-intensity interventions, such as telephone and internet-based strategies, can effectively engage individuals with alcohol use disorders (AUDs) who typically do not seek help, addressing barriers to treatment access.

These interventions not only benefit those with mild to moderate alcohol misuse but also support individuals with more severe AUDs, potentially leading to increased help-seeking behavior when necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building the first step: a review of low-intensity interventions for stepped care. McKellar, J., Austin, J., Moos, R.[2021]

A pilot study at a private northeastern university showed that implementing a stepped care approach for students mandated to attend an alcohol program resulted in high retention rates and participant satisfaction.

Stepped care, which tailors treatment levels based on individual responses, demonstrates potential for effectively addressing alcohol policy violations among college students.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stepped care for mandated college students: a pilot study. Borsari, B., O'Leary Tevyaw, T., Barnett, NP., et al.[2019]

An individual participant-level data meta-analysis of 17 randomized clinical trials involving 6,713 college students found that brief motivational interventions (BMIs) had very small and statistically insignificant effects on reducing heavy drinking and related problems.

However, participants who received individual motivational interviews with personalized feedback showed a small but statistically significant reduction in alcohol problems, indicating that this specific approach may be more effective than other BMI types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief motivational interventions for college student drinking may not be as powerful as we think: an individual participant-level data meta-analysis. Huh, D., Mun, EY., Larimer, ME., et al.[2018]

A stepped care approach for addressing problem drinking, which starts with a brief intervention and intensifies if needed, was found to be as effective as a full-care approach while requiring significantly less intervention time.

Both the stepped care and full-care interventions showed small to medium improvements in drinking outcomes compared to an untreated control group, suggesting that even minimal interventions can be beneficial for at-risk drinkers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a telephone-based stepped care intervention for alcohol-related disorders: a randomized controlled trial. Bischof, G., Grothues, JM., Reinhardt, S., et al.[2018]

Alcohol-related liver disease (ALD) is a significant health issue with increasing prevalence, and early detection through non-invasive tests is crucial for better management and outcomes.

Abstinence from alcohol is essential for improving outcomes in established ALD, and while liver transplantation is an option for advanced cases, there is a need for more effective medical interventions and research funding to develop new treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in the understanding and management of alcohol-related liver disease. Thursz, M., Lingford-Hughes, A.[2023]

Alcohol-related liver disease (ALD) is a significant health issue in Latin America, primarily driven by excessive alcohol consumption, with men at risk after more than 3 drinks per day and women after more than 2 drinks per day.

Prolonged abstinence from alcohol is the most effective treatment for reducing long-term health risks in ALD patients, and new therapies like G-CSF and N-acetylcysteine are being explored, while liver transplantation may be necessary for end-stage cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol-related liver disease: Clinical practice guidelines by the Latin American Association for the Study of the Liver (ALEH). Arab, JP., Roblero, JP., Altamirano, J., et al.[2020]

A joint meeting of the EASL and AASLD focused on addressing alcohol-related liver disease, aiming to identify consensus on reducing its burden and improving patient outcomes.

Key goals included finding ways to lower alcohol consumption, developing better diagnostic and prognostic markers, and establishing a framework for testing new treatments with clear endpoints.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol-Related Liver Disease: Areas of Consensus, Unmet Needs and Opportunities for Further Study. Szabo, G., Kamath, PS., Shah, VH., et al.[2022]

Alcohol is a major contributor to global mortality and liver-related deaths, highlighting the importance of identifying and treating alcohol use disorders, especially in patients with liver disease.

Acamprosate is an effective first-line pharmacological treatment that helps prevent relapse in patients with alcohol dependence, with a favorable safety profile and no significant liver toxicity reported, making it a suitable option for those with liver disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of alcohol use disorder in patients with liver disease. Nielsen, AS., Askgaard, G., Thiele, M.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Efficacy of psychosocial interventions to reduce alcohol use in comorbid alcohol use disorder and alcohol-related liver disease: a systematic review of randomized controlled trials. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Management of alcohol use disorder in patients with chronic liver disease. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Efficacy of motivational enhancement therapy on alcohol use disorders in patients with chronic hepatitis C: a randomized controlled trial. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Identification of Quantifiable Predictors of Relapse in Patients with Alcohol-Associated Liver Disease. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy of counselor vs. computer-delivered intervention with mandated college students. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Two brief alcohol interventions for mandated college students. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Building the first step: a review of low-intensity interventions for stepped care. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Stepped care for mandated college students: a pilot study. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Brief motivational interventions for college student drinking may not be as powerful as we think: an individual participant-level data meta-analysis. [2018]

10. Ireland pubmed.ncbi.nlm.nih.gov

Evaluation of a telephone-based stepped care intervention for alcohol-related disorders: a randomized controlled trial. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Advances in the understanding and management of alcohol-related liver disease. [2023]

12. Mexico pubmed.ncbi.nlm.nih.gov

Alcohol-related liver disease: Clinical practice guidelines by the Latin American Association for the Study of the Liver (ALEH). [2020]

13. United States pubmed.ncbi.nlm.nih.gov

Alcohol-Related Liver Disease: Areas of Consensus, Unmet Needs and Opportunities for Further Study. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Treatment of alcohol use disorder in patients with liver disease. [2022]