Alcohol Treatment Outcomes Following Early vs. Standard Liver Transplant for SAH

Not Applicable

Recruiting

• Conditions: Alcohol Use Disorder; Alcoholic Hepatitis
• Interventions: Behavioral: Integrated AUD Treatment

• Registration Number: NCT03845205
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed Description

In the United States, alcoholic liver disease (ALD) is the second most common indication for liver transplant (LT). Traditionally, ALD patients have been required to complete a six-month mandatory period of alcohol abstinence before LT. More recently early LT for severe alcoholic hepatitis is being performed without any pre-transplant alcohol treatment because of the high medical acuity and mortality associated with this disease. Importantly, the limited studies to-date demonstrate comparable survival among early (ELT) versus standard (SLT) transplant recipients. Return to alcohol use is a major concern for all LT recipients with ALD, with estimates of alcohol relapse ranging between 16 and 49%. Although most LT clinics have enforced pre-LT alcohol treatment, far less attention has been paid to post-LT services, despite the high risk and severe consequences of relapse during this period. Numerous evidence-based treatments are available for alcohol use disorder (AUD). In recent years, the investigators and others have developed web- and text-based versions of these empirically-supported interventions to expand the reach and replicability outside of formal alcohol clinic settings. Delivery of AUD interventions in non-traditional settings is feasible, acceptable to patients, and effective in reducing alcohol use. The investigators propose to implement and evaluate the effects of alcohol treatment integrated into routine post-LT care. All patients receive physician instructions to stop drinking and engage in alcohol services (treatment as usual: TAU). ELT (N=100) and SLT (N=100) patients will be randomized on a 2:1 basis to integrated AUD treatment (IAT) or TAU. IAT will include computer-delivered BI in the hospital, nurse-delivered alcohol monitoring counseling at each outpatient LT follow-up visit, and at-home participation in web-based, 7-session CBT4CBT, supplemented by tailored text messages. Also, because of the evidence that ALD patients significantly underreport drinking to LT providers, the investigators will compare post-LT alcohol relapse rates using a well-validated biomarker of recent drinking (PEth), patient self-report on a validated alcohol instrument, and patient report to LT provider. Finally, the investigators will identify predictors of post-LT alcohol use and treatment engagement for ELT and SLT patients. Key measures will include: alcohol use; engagement in alcohol treatment; retention in post-transplant follow-up care; mood and anxiety; and quality of life. Given the severe consequences of alcohol relapse among both ELT and SLT recipients, it is critical to accurately identify alcohol use and implement alcohol interventions early in the post-transplant period to optimize short- and long-term patient outcomes and ultimately tailor treatments for this high-risk population.

Study Timeline

• Study First Submitted: 2019-02-15
• Study First Submitted QC: 2019-02-15
• Study First Posted: 2019-02-19
• Study Start: 2020-11-20
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-28
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• English speaking

Exclusion Criteria

• too medically/psychiatrically ill to participate
• not able to provide informed consent due to cognitive impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Integrated AUD Treatment (IAT)	Integrated AUD Treatment	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.

Primary Outcome Measures

Name	Time	Method
Post-liver transplant survival as assessed by time to death	1 year	Time to death (in months)
Treatment engagement as assessed by proportion of kept LT follow-up appointments	1 year	Proportion of kept/scheduled LT follow-up appointments
Alcohol relapse as assessed by time to first Phosphatidyl ethanol (PEth) level ≥ 8 ng/mL	1 year	Time to first Phosphatidyl ethanol (PEth) level ≥ 8 ng/mL (minimum detectable level)

Secondary Outcome Measures

Name	Time	Method
Alcohol relapse as assessed by Timeline Followback Interview	1 year	Any alcohol use reported on the Timeline Followback Interview

Trial Locations

Locations (1)

Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States