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NCT03902366 · ClinicalTrials.gov registry record
HCV and Co-morbid Alcohol Use Disorders: A Translational Investigation of Antiviral Therapy Outcomes on CNS Function
A clinical trial, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- 63
- Enrollment target
NCT03902366: Completed study, sponsored by VA Office of Research and Development.
NCT03902366 is a clinical trial that has completed, run by VA Office of Research and Development. The registered enrollment target is 63 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03902366 has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- 63 participants
- Enrollment target
Study Summary
The primary objective of this research project is to compare neuropsychiatric functioning, cortical activity, white matter integrity, and immune response among Veterans with and without alcohol use disorder (AUD), before and after direct-acting antiviral (DAA) therapy \[a new treatment for chronic infection with the hepatitis C virus (HCV)\]. Demographically-matched comparison groups of Veterans without HCV (HCV-, with and without AUD) will similarly be evaluated to determine the relative contribution of HCV and an HCV "cure" to outcomes putatively affected by alcohol abuse. Two specific aims are proposed. Aim 1: Determine the impact of DAA therapy and a sustained viral response on central nervous system (CNS) function. Aim 2: Evaluate the effects of AUD and unhealthy alcohol drinking on DAA therapy outcomes and CNS function. The information learned will address a critical gap in knowledge concerning the effects of alcohol use on DAA therapy outcomes and will help inform treatment guidelines that could be translated to clinical practice, such as targeted interventions to treat AUD in conjunction with HCV infection and follow-up strategies for patients who successfully complete DAA therapy but then need care for other potential CNS-related outcomes.
Primary Outcome
The Attention Module is a marker of attentional capacity, working memory, and processing speed. T-scores are derived by converting raw scores using normative tables that account for age and education. T-scores range from 20 to 80 with a mean of 50 and standard deviation of 10. Lower T-scores (below 40) indicate below average performance and higher T-scores (above 60) indicate above-average performance. NAB Attention Module subtests include: Dots, Numbers and Letters, Driving Scenes, Digits Forwa
Interventions
- DIAGNOSTIC_TEST Neuropsychological assessment
- BEHAVIORAL Neuroimaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2019-05-16 |
| Est. Completion | 2023-12-29 |
What the finished NCT03902366 record still lists
NCT03902366 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 63 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Neuropsychological assessment is the first listed.
NCT03902366 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03902366 about?
NCT03902366 is a clinical study titled "HCV and Co-morbid Alcohol Use Disorders: A Translational Investigation of Antiviral Therapy Outcomes on CNS Function". The primary objective of this research project is to compare neuropsychiatric functioning, cortical activity, white matter integrity, and immune response among Veterans with and without alcohol use disorder (AUD), before and after direct-acting antiviral (DAA) therapy \[a new treatment for chronic i...
What is the current status of trial NCT03902366?
This trial is currently completed. The enrollment target is 63 participants. The study started on 2019-05-16. Estimated completion is 2023-12-29.
What interventions are being tested in trial NCT03902366?
The interventions under investigation include: Neuropsychological assessment (DIAGNOSTIC_TEST), Neuroimaging (BEHAVIORAL).
Who is sponsoring clinical trial NCT03902366?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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