Health TrialsbyHealthPanel

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

ConditionsAlcohol Use DisorderAlcoholic Hepatitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

English speaking

Disqualifiers

too medically/psychiatrically ill to participate

not able to provide informed consent due to cognitive impairment

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Integrated AUD Treatment (IAT)Experimental treatment 1 intervention
Group B: Treatment As UsualNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Treatment engagement as assessed by proportion of kept LT follow-up appointments

Proportion of kept/scheduled LT follow-up appointments

Time frame
1 year
2

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)

Time frame
1 year
3

Post-liver transplant survival as assessed by time to death

Time to death (in months)

Time frame
1 year

Secondary outcomes

1

Alcohol relapse as assessed by Timeline Followback Interview

Any alcohol use reported on the Timeline Followback Interview

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov
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