Recruiting

Early vs. Standard

Sponsor:

Johns Hopkins University

Code:

NCT03845205

Conditions

Alcohol Use Disorder

Alcoholic Hepatitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Integrated AUD Treatment

Study Details

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.

Conditions

Alcohol Use Disorder

Alcoholic Hepatitis

Study ID

NCT03845205

Start date

Nov 20, 2020

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • English speaking

Exclusion Criteria:

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

Primary outcome measure

  • Treatment engagement as assessed by proportion of kept LT follow-up appointments [ Time Frame: 1 year ]
  • Alcohol relapse as assessed by time to first Phosphatidyl ethanol (PEth) level ≥ 8 ng/mL [ Time Frame: 1 year ]
  • Post-liver transplant survival as assessed by time to death [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

MARY E MCCAUL, PhD

410-955-9526mmccaul1@jhmi.edu

Victor Chen, MD

410-550-1793pchen37@jhmi.edu

Locations

Johns Hopkins University School of Medicine

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Mary E McCaul, Ph.D.

410-955-9526mmccaul1@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Keywords

  • Alcohol treatment
  • Liver transplant
  • Motivational intervention
  • Cognitive-behavioral therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-06-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.