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NCT Number: NCT03267069

Evaluating Alcohol Use in Alcoholic Liver Disease

This prospective, analytic observational study will investigate alcohol recidivism in patients with alcoholic liver disease. All adult subjects presenting with alcoholic liver disease are considered for inclusion. Subjects able to give consent are included.

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Key information

Conditions

Alcoholic Liver Disease Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Digestive System Diseases Liver Diseases Liver Diseases, Alcoholic Substance-Related Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

This is a longitudinal observational study. Subjects with a diagnosis of alcoholic liver disease (acute alcoholic hepatitis or alcoholic cirrhosis) who present to Weill Cornell Medical Center or Columbia University Medical Center New York Presbyterian Hospital or the Gastroenterology and Hepatology Clinic will be invited to join this study, which entails a survey at baseline and follow-up at 3, 6, 9, 12, 15, and 18 months and then at 2, 5, and 10 years. Follow-up will consist of a chart review, a phone or in person interview, and most recent clinic visit interview for alcohol recidivism. The clinical providers will be blinded to the survey results.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • alcoholic liver disease able to consent

Exclusion criteria

  • without alcoholic liver disease unable to consent

Treatment and study plan

Survey

Other

surveys will be administered at inclusion and follow-ups

Primary outcomes

  1. alcohol recidivism assessed by questionnaire

    Time frame: 6 months

    Follow-up questionnaires will be administered at 6 months assessing for alcohol use

  2. alcohol recidivism assessed by clinical interview

    Time frame: 6 months

    Follow-up interviews will be conducted at 6 months assessing for alcohol use

  3. alcohol recidivism assessed by urine ethyl glucuronide

    Time frame: 6 months

    Follow-up urine testing may be conducted at 6 months assessing for alcohol use

  4. alcohol recidivism assessed by blood

    Time frame: 6 months

    Follow-up blood testing may be conducted at 6 months assessing for alcohol use

Secondary outcomes

  1. alcohol recidivism assessed by questionnaire

    Time frame: after 6 months

    Follow-up questionnaires will be administered after 6 months assessing for alcohol use

  2. alcohol recidivism assessed by clinical interview

    Time frame: after 6 months

    Follow-up clinical interviews will be conducted after 6 months assessing for alcohol use

  3. alcohol recidivism assessed by urine ethyl glucuronide

    Time frame: after 6 months

    Follow-up urine testing may be conducted after 6 months assessing for alcohol use

  4. alcohol recidivism assessed by blood

    Time frame: after 6 months

    Follow-up blood testing may be conducted after 6 months assessing for alcohol use

Study contacts

Contact information is provided by the study sponsor or research team.

Nicole T Shen, MD

CONTACT

[email protected]

3146095911

Robert S Brown, MD, MPH

CONTACT

[email protected]

(646) 962-5483

Sponsors and collaborators

Lead sponsor

Nicole T Shen

Other

Registry information

Important dates

Study start
2016
Primary completion
2026
Study completion
2027
First posted
Aug 30, 2017
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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