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Evaluating Alcohol Use in Alcoholic Liver Disease

Evaluating Alcohol Use in Alcoholic Liver Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03267069
Enrollment
160
Registered
2017-08-30
Start date
2016-11-27
Completion date
2027-11-01
Last updated
2019-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholic Liver Disease

Brief summary

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.

Detailed description

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.

Interventions

OTHERsurvey

surveys will be administered at inclusion and follow-ups

Sponsors

Nicole T Shen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* alcoholic liver disease able to consent

Exclusion criteria

* without alcoholic liver disease unable to consent

Design outcomes

Primary

MeasureTime frameDescription
alcohol recidivism assessed by blood6 monthsFollow-up blood testing may be conducted at 6 months assessing for alcohol use
alcohol recidivism assessed by questionnaire6 monthsFollow-up questionnaires will be administered at 6 months assessing for alcohol use
alcohol recidivism assessed by clinical interview6 monthsFollow-up interviews will be conducted at 6 months assessing for alcohol use
alcohol recidivism assessed by urine ethyl glucuronide6 monthsFollow-up urine testing may be conducted at 6 months assessing for alcohol use

Secondary

MeasureTime frameDescription
alcohol recidivism assessed by questionnaireafter 6 monthsFollow-up questionnaires will be administered after 6 months assessing for alcohol use
alcohol recidivism assessed by clinical interviewafter 6 monthsFollow-up clinical interviews will be conducted after 6 months assessing for alcohol use
alcohol recidivism assessed by urine ethyl glucuronideafter 6 monthsFollow-up urine testing may be conducted after 6 months assessing for alcohol use
alcohol recidivism assessed by bloodafter 6 monthsFollow-up blood testing may be conducted after 6 months assessing for alcohol use

Countries

United States

Contacts

Primary ContactNicole T Shen, MD
nts9004@nyp.org3146095911
Backup ContactRobert S Brown, MD, MPH
rsb2005@med.cornell.edu(646) 962-5483

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026