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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• English speaking

Locations
United States
Maryland
Johns Hopkins University School of Medicine
RECRUITING
Baltimore
Contact Information
Primary
MARY E MCCAUL, PhD
mmccaul1@jhmi.edu
410-955-9526
Backup
Victor Chen, MD
pchen37@jhmi.edu
410-550-1793
Time Frame
Start Date: 2020-11-20
Estimated Completion Date: 2027-06
Participants
Target number of participants: 200
Treatments
Experimental: 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.
No_intervention: 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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov