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Alcohol Biomarkers in Post-Liver Transplant Patients

NCT01812226 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 214

Last updated 2023-02-24

No results posted yet for this study

Summary

The aim of this study is to compare the predictive validity and reliability of PEth testing at detecting alcohol use in post liver transplant patients. A prospective cohort study will be used to test the primary hypothesis. Subjects enrolled in the study will be followed for 12 months with biomarker levels drawn at baseline, six and 12 months. The baseline interview will inquire about the previous 30 day alcohol and tobacco use; lifetime and 12 month Diagnostic and Statistical Manual-IV criteria for alcohol abuse and/or dependence; prior alcohol treatment; history of abstinence prior to transplant; co-morbid medical issues; and depression. The six and 12 months interview will focus on previous 30 day alcohol use. The baseline, six and 12 months interviews will be conducted face-to-face at each site. While many patients who receive a transplant do not live near the academic medical center that performed the surgery patient, they normally have a transplant clinic visit 1-2 times per year. Medical records and transplant databases will be assessed to assess the other variables of interest.

Conditions

  • Alcohol-related Liver Disease

Sponsors & Collaborators

Principal Investigators

  • Michael F Fleming, MD, MPH · Northwestern University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01812226 on ClinicalTrials.gov