Integrated AUD Treatment for Alcoholic Hepatitis

Overseen By Victor Chen, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Severe illness, Cognitive impairment, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

200 Participants Needed

Trial Summary

What is the purpose of this trial?

Given the severe consequences of alcohol relapse following liver transplantation for alcoholic hepatitis (AH-LT), it is critical to accurately identify alcohol use and implement alcohol interventions early in the post-transplant period to optimize patient outcomes. The proposed randomized clinical trial will examine the implementation and effects of integrated, person- and computer-delivered alcohol treatment compared to standard care on alcohol use (assessed by self-report and biomarker), mood, quality of life and survival following AH-LT. Predictors of 12-month post-transplant alcohol outcomes will be explored to allow future improved tailoring and targeting of these treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What data supports the effectiveness of the Integrated AUD Treatment for Alcoholic Hepatitis?

Research shows that managing alcohol use disorder (AUD) in patients with liver disease, including alcoholic hepatitis, can improve clinical outcomes. Integrated care models, which combine medical and mental health treatment, are effective for complex conditions like alcohol-related liver disease. ^{1 2 3 4 5}

Is Integrated AUD Treatment safe for humans?

The research mentions that combining medication approved for treating alcohol use disorder (AUD) with behavioral therapy is generally safe and can improve health and quality of life. Additionally, ketamine infusions have been found to be a potentially safe option for managing alcohol withdrawal syndrome. ^{2 3 5 6 7}

How is the Integrated AUD Treatment for Alcoholic Hepatitis different from other treatments?

The Integrated AUD Treatment for Alcoholic Hepatitis is unique because it combines both medical and psychosocial interventions, involving a team of psychiatrists and liver specialists, to address alcohol use disorder in patients with liver disease. This integrated approach aims to achieve and maintain abstinence, which is crucial for improving outcomes in alcoholic liver disease. ^{2 3 8 9 10}

Research Team

Mary E McCaul, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for English-speaking individuals who have undergone a liver transplant due to severe alcoholic hepatitis. Participants must be medically and mentally stable enough to give informed consent and engage in the study without significant cognitive impairment.

Inclusion Criteria

English speaking

Exclusion Criteria

I am not too sick or mentally unwell to take part in a study.

I cannot give informed consent because of cognitive issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive integrated alcohol use disorder treatment or treatment as usual post-liver transplant

12 months

Regular outpatient follow-up visits

Follow-up

Participants are monitored for alcohol relapse, survival, and treatment engagement

12 months

Regular phone calls and blood draws for monitoring

Treatment Details

Interventions

• Integrated AUD Treatment

Trial Overview The study tests an integrated alcohol use disorder treatment, delivered both personally and via computer, against standard care. It aims to see how this affects post-transplant alcohol use, mood, quality of life, and survival rates.

Participant Groups

Group I: Integrated AUD Treatment (IAT) Experimental Treatment 1 Intervention

IAT will include computer-delivered CBI in the hospital, nurse-delivered clinical monitoring and treatment adherence counseling, and at-home participation in web-based, 7-session computerized cognitive-behavioral therapy (CBT4CBT), supplemented by tailored text messages. Alcohol pharmacotherapy will be added to behavioral treatments as needed.

Group II: Treatment As Usual Active Control 1 Intervention

All LT patients receive physician instructions to not drink alcohol. Consistent with current discharge procedures, AH patients are encouraged to engage in alcohol treatment services. Patients receive regular blood draws for monitoring of liver function, and regular phone calls for post-operative monitoring.

Integrated AUD Treatment is already approved in United States, European Union for the following indications:

Approved in United States as Integrated AUD Treatment for:

• Alcoholic Hepatitis
• Alcohol-Associated Liver Disease

Approved in European Union as Integrated AUD Treatment for:

• Alcoholic Hepatitis
• Alcohol-Related Liver Disease

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Findings from Research

The rising incidences of alcohol use disorder (AUD) and alcohol-related liver disease (ALD), particularly accelerated by the COVID-19 pandemic, highlight the urgent need for integrated care models that address both conditions simultaneously.

Hepatologists often lack the training to effectively diagnose and treat AUD in patients with ALD, indicating a need for new management strategies that adapt to the complexities of patients presenting with both diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary Care of Alcohol-related Liver Disease and Alcohol Use Disorder: A Narrative Review for Hepatology and Addiction Clinicians. Shroff, H., Gallagher, H.[2023]

Alcohol use disorder (AUD) is a significant factor in alcoholic liver disease (ALD), and effective treatment requires a collaborative approach between patients and healthcare providers.

Diagnosing AUD involves comprehensive methods including history taking, physical exams, screening questionnaires, and alcohol biomarkers, which have their own advantages and limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol Use Disorders in Alcoholic Liver Disease. Mellinger, JL., Winder, GS.[2019]

In a study of 103 inpatients undergoing treatment for alcohol use disorder, the risk of experiencing a first relapse decreased steadily over 42 days of abstinence, indicating that the longer patients remain sober, the less likely they are to relapse initially.

However, once a patient relapsed, the risk of subsequent relapses remained stable and high, suggesting that additional support and relapse-prevention strategies are crucial for individuals who have already experienced a relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the relapse risk during treatment? Survivor analysis of single and multiple relapse events in inpatients with alcohol use disorder as part of an observational study. Senn, S., Volken, T., Rösner, S., et al.[2022]

Management of alcohol use disorder (AUD) in patients with liver disease significantly improves outcomes, with lower rates of liver decompensation, 30-day readmission, and patient mortality compared to standard care.

For liver transplant recipients, integrated care involving both addiction and hepatology teams leads to better results, with reduced odds of alcohol relapse and mortality, highlighting the importance of simultaneous AUD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous Management of Alcohol Use Disorder and Liver Disease: A Systematic Review and Meta-analysis. Elfeki, MA., Abdallah, MA., Leggio, L., et al.[2023]

In a study of 35,682 Veterans with cirrhosis and alcohol use disorder (AUD), only 14% received treatment for AUD within 180 days, highlighting a significant gap in care for this population.

Patients who did receive behavioral or pharmacotherapy for AUD experienced a notable reduction in hepatic decompensation (6.5% vs. 11.6%) and a significant decrease in long-term all-cause mortality (51% vs. 58%), indicating that effective AUD treatment can improve clinical outcomes in those with cirrhosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Alcohol Use Disorder Treatment on Clinical Outcomes Among Patients With Cirrhosis. Rogal, S., Youk, A., Zhang, H., et al.[2021]

Alcohol use disorder (AUD) affects approximately 14.6 million Americans, yet very few receive treatment, highlighting a significant gap in care despite the availability of effective FDA-approved medications.

Combining FDA-approved medications with evidence-based behavioral therapy can lead to higher rates of abstinence and reduced relapse risk, improving overall health and quality of life for individuals with AUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alcohol Use Disorder: The Role of Medication in Recovery. Mason, BJ., Heyser, CJ.[2021]

Intravenous ketamine infusions have shown promise in treating alcohol use disorder (AUD) by reducing cravings and alcohol consumption, as well as increasing abstinence rates compared to standard treatments, based on a review of 10 human studies.

In managing alcohol withdrawal syndrome (AWS), ketamine used alongside standard benzodiazepine therapy has been associated with quicker resolution of severe symptoms like delirium tremens, reduced ICU stays, and a lower risk of intubation, although some adverse effects like oversedation and headache were noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The therapeutic use and efficacy of ketamine in alcohol use disorder and alcohol withdrawal syndrome: a scoping review. Goldfine, CE., Tom, JJ., Im, DD., et al.[2023]

Alcohol use disorder (AUD) is prevalent among patients with alcoholic liver disease (ALD), making it crucial to screen all ALD patients for AUD using tools like the AUDIT and AUDIT-C.

Baclofen is recommended as the first-line medication for managing AUD in ALD patients, combined with psychological therapies such as cognitive behavioral therapy, emphasizing the importance of integrated care and ongoing support for better treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Alcohol Use Disorder in Patients With Alcoholic Liver Disease. Murthy, P., Shadakshari, D., Mahadevan, J., et al.[2023]

Alcohol use disorders (AUDs) are a major health issue in Europe, leading to significant disease and disability, with alcoholic liver disease (ALD) being the most common alcohol-related condition.

The primary treatment for ALD is complete alcohol abstinence, as ongoing drinking severely limits the effectiveness of medical and surgical interventions; thus, managing AUDs in patients with ALD requires a comprehensive approach that includes medical, psychosocial, and pharmacological strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of alcohol use disorders in patients with alcoholic liver disease. Addolorato, G., Mirijello, A., Barrio, P., et al.[2022]

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]

References

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

Multidisciplinary Care of Alcohol-related Liver Disease and Alcohol Use Disorder: A Narrative Review for Hepatology and Addiction Clinicians. [2023]

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

Alcohol Use Disorders in Alcoholic Liver Disease. [2019]

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

What is the relapse risk during treatment? Survivor analysis of single and multiple relapse events in inpatients with alcohol use disorder as part of an observational study. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Simultaneous Management of Alcohol Use Disorder and Liver Disease: A Systematic Review and Meta-analysis. [2023]

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

Impact of Alcohol Use Disorder Treatment on Clinical Outcomes Among Patients With Cirrhosis. [2021]

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

Alcohol Use Disorder: The Role of Medication in Recovery. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

The therapeutic use and efficacy of ketamine in alcohol use disorder and alcohol withdrawal syndrome: a scoping review. [2023]

8. India pubmed.ncbi.nlm.nih.gov

Management of Alcohol Use Disorder in Patients With Alcoholic Liver Disease. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

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