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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help individuals who have undergone liver transplants due to alcoholic hepatitis maintain sobriety. It compares a special program called Integrated AUD Treatment—which includes computer-based therapy, nurse support, and personalized messages—with usual care, which involves regular doctor visits and advice not to drink. The goal is to determine if this integrated approach improves mood, quality of life, and survival rates more effectively than standard care. Individuals who have recently had a liver transplant and speak English may be suitable for this study, provided they are medically stable and able to give consent. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance post-transplant care.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that treatments combining behavior therapy and medication for alcohol use disorder (AUD) are generally easy for people to handle. Previous studies have found that both computer-based and in-person counseling usually lead to only minor side effects. Participants might experience mild headaches or tiredness, but these effects are typically short-lived.

In this trial, the AUD treatment includes computer programs and support from nurses to help patients adhere to their treatment plan. Medication to help stop drinking is also available if needed. Safety data from similar treatments in other studies suggest they are safe for most people, with no major health issues reported.

This trial is in the "Not Applicable" phase, indicating that while earlier phases might have shown the treatment is safe, this trial focuses more on its effectiveness. Prospective participants should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Integrated AUD Treatment for alcoholic hepatitis because it combines innovative approaches that go beyond standard care. Unlike typical treatments that may rely solely on physician instructions and monitoring, this approach integrates computer-delivered interventions, nurse support, and web-based cognitive-behavioral therapy. Additionally, the treatment is personalized with tailored text messages and can include alcohol pharmacotherapy if needed. This multi-faceted method not only addresses the physical aspects of the condition but also the behavioral and psychological components, offering a more comprehensive strategy to improve patient outcomes.

What evidence suggests that the Integrated AUD Treatment could be effective for alcoholic hepatitis?

Research has shown that combining different treatments can help reduce alcohol use after a liver transplant due to alcoholic hepatitis. In this trial, participants in the Integrated AUD Treatment (IAT) arm will receive a combination of computer-delivered interventions, nurse support, and therapy to maintain sobriety. This approach also includes personalized text messages and medication when needed, further aiding recovery. Specifically, patients who participated in these combined treatments were more likely to avoid drinking again, improving their mood and quality of life. Evidence indicates that this method not only helps reduce alcohol use but also increases survival rates after a liver transplant. ^{1 3 6 7 8}

Who Is on the Research Team?

Mary E McCaul, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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]

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]

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]

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 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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10503679/

Improving alcohol treatment engagement using integrated ... ... intervention to increase alcohol use disorder (AUD) treatment ... alcoholic hepatitis) access AUD treatment after their initial diagnosis.

2. withpower.com withpower.com/trial/phase-hepatitis-10-2020-809e1

Integrated AUD Treatment for Alcoholic Hepatitis What is the purpose of this trial? Given the severe consequences of alcohol relapse following liver transplantation for alcoholic hepatitis (AH-LT), it is ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1542356523001593

Alcohol-Associated Liver Disease: Integrated Management ... For the clinical diagnosis of AH, a National Institute on Alcohol Abuse and Alcoholism consortia defined the criteria listed in Table 1. Imaging should exclude ...

4. thelancet.com thelancet.com/journals/langas/article/PIIS2468-1253(25)00193-1/abstract

Reducing alcohol-associated liver disease burden in ... The National Institute on Alcohol Abuse and Alcoholism organised a multistakeholder workshop focused on reducing the burden of ALD. Decreasing ...

5. ascpjournal.biomedcentral.com ascpjournal.biomedcentral.com/articles/10.1186/s13722-024-00448-8

Treatment of alcohol use disorder in patients with alcohol ... Patterns of alcohol use after early liver transplantation for alcoholic hepatitis. Clin Gastroenterol Hepatol. 2022;20(2):409-418.e5. https ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10500286/

Integrated Multidisciplinary Management of Alcohol- ... Alcohol-Associated Liver Disease. AH. Alcoholic Hepatitis. AUD. Alcohol Use Disorder. LT. Liver Transplant. References. 1. GBD 2017 Cirrhosis ...

7. grants.nih.gov grants.nih.gov/grants/guide/rfa-files/RFA-AA-24-004.html

Expired RFA-AA-24-004: Limited Competition ... Alcoholic Hepatitis”. The existing program of “AH Clinical and Translational Network”, hereafter termed “AlcHepNet”, has been sponsored by ...

8. nature.com nature.com/articles/s41575-024-00936-x

Designing clinical trials to address alcohol use and ... In the USA, a report from the National Institute on Alcohol Abuse and Alcoholism (NIAAA) showed that 52% of cirrhosis-related deaths in 2019 ...