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

NCT ID: NCT03845205

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-20
• Study Completion Date: 2027-06-30

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.

Conditions

Alcohol Use Disorder; Alcoholic Hepatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Integrated AUD Treatment (IAT)

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 Type: EXPERIMENTAL

Integrated AUD Treatment

Intervention Type: BEHAVIORAL

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.

Treatment As Usual

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Integrated AUD Treatment

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Computerized brief alcohol intervention (CBI); CBT4CBT; Text Messaging

Eligibility Criteria

Inclusion Criteria

• English speaking

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary E McCaul, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

MARY E MCCAUL, PhD

Role: CONTACT

mmccaul1@jhmi.edu

410-955-9526

Victor Chen, MD

Role: CONTACT

pchen37@jhmi.edu

410-550-1793

Facility Contacts

Mary E McCaul, Ph.D.

Role: primary

mmccaul1@jhmi.edu

410-955-9526

References

Lee BP, Chen PH, Haugen C, Hernaez R, Gurakar A, Philosophe B, Dagher N, Moore SA, Li Z, Cameron AM. Three-year Results of a Pilot Program in Early Liver Transplantation for Severe Alcoholic Hepatitis. Ann Surg. 2017 Jan;265(1):20-29. doi: 10.1097/SLA.0000000000001831.

Reference Type: BACKGROUND

PMID: 27280501 (View on PubMed)

Weeks SR, Sun Z, McCaul ME, Zhu H, Anders RA, Philosophe B, Ottmann SE, Garonzik Wang JM, Gurakar AO, Cameron AM. Liver Transplantation for Severe Alcoholic Hepatitis, Updated Lessons from the World's Largest Series. J Am Coll Surg. 2018 Apr;226(4):549-557. doi: 10.1016/j.jamcollsurg.2017.12.044. Epub 2018 Feb 2.

Reference Type: BACKGROUND

PMID: 29409981 (View on PubMed)

Fleming MF, Smith MJ, Oslakovic E, Lucey MR, Vue JX, Al-Saden P, Levitsky J. Phosphatidylethanol Detects Moderate-to-Heavy Alcohol Use in Liver Transplant Recipients. Alcohol Clin Exp Res. 2017 Apr;41(4):857-862. doi: 10.1111/acer.13353. Epub 2017 Mar 20.

Reference Type: BACKGROUND

PMID: 28196282 (View on PubMed)

Chander G, Hutton HE, Lau B, Xu X, McCaul ME. Brief Intervention Decreases Drinking Frequency in HIV-Infected, Heavy Drinking Women: Results of a Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2015 Oct 1;70(2):137-45. doi: 10.1097/QAI.0000000000000679.

Reference Type: BACKGROUND

PMID: 25967270 (View on PubMed)

Kiluk BD, Devore KA, Buck MB, Nich C, Frankforter TL, LaPaglia DM, Yates BT, Gordon MA, Carroll KM. Randomized Trial of Computerized Cognitive Behavioral Therapy for Alcohol Use Disorders: Efficacy as a Virtual Stand-Alone and Treatment Add-On Compared with Standard Outpatient Treatment. Alcohol Clin Exp Res. 2016 Sep;40(9):1991-2000. doi: 10.1111/acer.13162. Epub 2016 Aug 4.

Reference Type: BACKGROUND

PMID: 27488212 (View on PubMed)

Other Identifiers

P50AA027054

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00152700

Identifier Type: -

Identifier Source: org_study_id