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Clinical Trials/NCT03845205
NCT03845205RecruitingNot Applicable

Alcohol Treatment Outcomes Following Early vs. Standard Liver Transplant for Severe Alcoholic Hepatitis (SAH)

Johns Hopkins University2 sites in 1 country200 target enrollmentStarted: November 20, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
200
Locations
2
Primary Endpoint
Post-liver transplant survival as assessed by time to death

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

Research Coordinator is blinded to treatment assignment

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • English speaking

Exclusion Criteria

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

Arms & Interventions

Integrated AUD Treatment (IAT)

Experimental

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.

Intervention: Integrated AUD Treatment (Behavioral)

Treatment As Usual

No 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.

Outcomes

Primary Outcomes

Post-liver transplant survival as assessed by time to death

Time Frame: 1 year

Time to death (in months)

Treatment engagement as assessed by proportion of kept LT follow-up appointments

Time Frame: 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

Time Frame: 1 year

Time to first Phosphatidyl ethanol (PEth) level ≥ 8 ng/mL (minimum detectable level)

Secondary Outcomes

  • Alcohol relapse as assessed by Timeline Followback Interview(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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