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NCT01812226 · ClinicalTrials.gov registry record
Alcohol Biomarkers in Post-Liver Transplant Patients
A clinical trial, sponsored by Northwestern University.
- Completed
- Registry status
- 214
- Enrollment target
NCT01812226: Completed study, sponsored by Northwestern University.
NCT01812226 is a clinical trial that has completed, run by Northwestern University. The registered enrollment target is 214 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01812226 has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- 214 participants
- Enrollment target
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.
Primary Outcome
The criteria standard on which we will base the specificity will be a combination of patient self-report, family member report and clinician/medical record data. Subjects in whom any concern of current alcohol use, from any of these sources, would be considered a positive for current drinking. The PEth levels would then be compared to this standard of current alcohol use Data from previous research suggests PEth has a specificity close to 100%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2013-03 |
| Est. Completion | 2015-10 |
What the finished NCT01812226 record still lists
NCT01812226 is an observational study that tracks outcomes without assigning an intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01812226 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01812226 about?
NCT01812226 is a clinical study titled "Alcohol Biomarkers in Post-Liver Transplant Patients". 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...
What is the current status of trial NCT01812226?
This trial is currently completed. The enrollment target is 214 participants. The study started on 2013-03. Estimated completion is 2015-10.
Who is sponsoring clinical trial NCT01812226?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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