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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT03845205
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Integrated AUD Treatment — 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.

Study Details

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.

Key Dates

Start date
Nov 20, 2020
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Treatment engagement as assessed by proportion of kept LT follow-up appointments [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins University School of MedicineBaltimoreMaryland21205
Mary E McCaul, Ph.D.
[email protected]
410-955-9526

Find similar trials in Baltimore, MD

By condition
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By specialty
Behavioral healthAddiction medicine
By research site
Johns Hopkins University School of Medicine· Baltimore, MD

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