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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Alcohol relapse as assessed by Timeline Followback Interview
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.
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,274 Previous Clinical Trials
14,840,317 Total Patients Enrolled
14 Trials studying Alcoholism
1,827 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
811 Previous Clinical Trials
1,158,087 Total Patients Enrolled
428 Trials studying Alcoholism
778,157 Patients Enrolled for Alcoholism
Mary E McCaul, PhDPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
65 Total Patients Enrolled
1 Trials studying Alcoholism
65 Patients Enrolled for Alcoholism
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not too sick or mentally unwell to take part in a study.I cannot give informed consent because of cognitive issues.
Research Study Groups:
This trial has the following groups:- Group 1: Integrated AUD Treatment (IAT)
- Group 2: Treatment As Usual
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