CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 63 enrolled
Drug / intervention
Neuropsychological assessment +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03902366
NCT03902366N/ACompleted

HCV and Co-morbid Alcohol Use Disorders: A Translational Investigation of Antiviral Therapy Outcomes on CNS Function

VA Office of Research and Development·observational·Posted Apr 4, 2019·Updated Mar 27, 2025

In Brief

An observational study evaluating Neuropsychological assessment and Neuroimaging for Hepatitis C and Alcohol Use Disorder. Completed, enrolled 63 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 4, 2019
Enrollment StartMay 16, 2019
Primary CompletionOct 31, 2023
Study CompletionDec 29, 2023
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 7.2 years ago

Interventions

Neuropsychological assessmentother

Clinical research staff will complete a standardized neuropsychiatric study visit protocol with eligible participants who provide informed consent. The protocol will be conducted twice for each participant (baseline and 6 months later).

Neuroimagingbehavioral

Subjects, well characterized with respect to their substance use, will be evaluated with functional magnetic resonance imaging (fMRI) tasks, resting state MRI (rsMRI), high resolution anatomical MRI, standard diffusion weighted imaging (DWI) and high angular resolution diffusion imaging (HARDI) at baseline and 6 months later.