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Behavioral Intervention

Integrated AUD Treatment for Alcoholic Hepatitis

N/A

Recruiting

Led By Mary E McCaul, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Not able to provide informed consent due to cognitive impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will examine the effects of integrated, person- and computer-delivered alcohol treatment compared to standard care on alcohol use, mood, quality of life and survival following AH-LT.

Who is the study for?

This trial is for English-speaking individuals who have undergone a liver transplant due to severe alcoholic hepatitis. Participants must be medically and mentally stable enough to give informed consent and engage in the study without significant cognitive impairment.

What is being tested?

The study tests an integrated alcohol use disorder treatment, delivered both personally and via computer, against standard care. It aims to see how this affects post-transplant alcohol use, mood, quality of life, and survival rates.

What are the potential side effects?

While specific side effects are not detailed for the interventions being studied (as they are behavioral treatments), participants may experience emotional or psychological discomfort when discussing their alcohol use.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot give informed consent because of cognitive issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Alcohol relapse as assessed by time to first Phosphatidyl ethanol (PEth) level ≥ 8 ng/mL

Post-liver transplant survival as assessed by time to death

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

Secondary study objectives

Alcohol relapse as assessed by Timeline Followback Interview

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Integrated AUD Treatment (IAT)Experimental Treatment1 Intervention

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.

Group II: Treatment As UsualActive Control1 Intervention

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.

0 / 1Eligibility criteria met