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

Primary Purpose

Alcohol Use Disorder, Alcoholic Hepatitis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integrated AUD Treatment
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring Alcohol treatment, Liver transplant, Motivational intervention, Cognitive-behavioral therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • English speaking

Exclusion Criteria:

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

Sites / Locations

  • Johns Hopkins University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Integrated AUD Treatment (IAT)

Treatment As Usual

Arm Description

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.

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 Outcome Measures

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

Secondary Outcome Measures

Alcohol relapse as assessed by Timeline Followback Interview
Any alcohol use reported on the Timeline Followback Interview

Full Information

First Posted
February 15, 2019
Last Updated
September 27, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03845205
Brief Title
Alcohol Treatment Outcomes Following Early vs. Standard Liver Transplant for SAH
Official Title
Alcohol Treatment Outcomes Following Early vs. Standard Liver Transplant for Severe Alcoholic Hepatitis (SAH)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Alcoholic Hepatitis
Keywords
Alcohol treatment, Liver transplant, Motivational intervention, Cognitive-behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Integrated AUD treatment (IAT) v Treatment as usual (TAU)
Masking
Outcomes Assessor
Masking Description
Research Coordinator is blinded to treatment assignment
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Integrated AUD Treatment (IAT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment As Usual
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Integrated AUD Treatment
Other Intervention Name(s)
Computerized brief alcohol intervention (CBI), CBT4CBT, Text Messaging
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment engagement as assessed by proportion of kept LT follow-up appointments
Description
Proportion of kept/scheduled LT follow-up appointments
Time Frame
1 year
Title
Alcohol relapse as assessed by time to first Phosphatidyl ethanol (PEth) level ≥ 8 ng/mL
Description
Time to first Phosphatidyl ethanol (PEth) level ≥ 8 ng/mL (minimum detectable level)
Time Frame
1 year
Title
Post-liver transplant survival as assessed by time to death
Description
Time to death (in months)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Alcohol relapse as assessed by Timeline Followback Interview
Description
Any alcohol use reported on the Timeline Followback Interview
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English speaking Exclusion Criteria: too medically/psychiatrically ill to participate not able to provide informed consent due to cognitive impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MARY E MCCAUL, PhD
Phone
410-955-9526
Email
mmccaul1@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
GEETANJALI CHANDER
Phone
443-287-2030
Email
GCHANDE1@JHMI.EDU
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary E McCaul, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary E McCaul, Ph.D.
Phone
410-955-9526
Email
mmccaul1@jhmi.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27280501
Citation
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.
Results Reference
background
PubMed Identifier
29409981
Citation
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.
Results Reference
background
PubMed Identifier
28196282
Citation
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.
Results Reference
background
PubMed Identifier
25967270
Citation
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.
Results Reference
background
PubMed Identifier
27488212
Citation
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.
Results Reference
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Alcohol Treatment Outcomes Following Early vs. Standard Liver Transplant for SAH

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