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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

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

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,257 Previous Clinical Trials

14,819,931 Total Patients Enrolled

14 Trials studying Alcoholism

1,827 Patients Enrolled for Alcoholism

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

799 Previous Clinical Trials

1,362,311 Total Patients Enrolled

422 Trials studying Alcoholism

985,008 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

Media Library

Integrated AUD Treatment (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03845205 — N/A

Alcoholism Research Study Groups: Integrated AUD Treatment (IAT), Treatment As Usual

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the participant roster of this medical study expanding?

"Affirmative. According to information published on clinicaltrials.gov, this medical study is still open for participants and was first posted in November 2020 with the most recent update occurring in September 2022. They are looking to enrol 200 patients at a single site."

Answered by AI

Is enrollment in this study still accepting new participants?

"The information on clinicaltrials.gov verifies that this research endeavour is recruiting participants. The initial posting was done on November 20th 2020 and the details were most recently updated September 8th 2022."

Answered by AI