Hepatitis C, Chronic; AUD Clinical Trial
Official title:
Hepatitis C Alcohol Reduction Treatment - Randomized Controlled Trial (Hep ART-RCT)
Subjects are being asked to take part in a research study to test two levels of alcohol services for patients with hepatitis C virus (HCV) who drink alcohol. The two levels differ in intensity of alcohol services and in whether or not they include a focus on liver health. The study will look at which level of alcohol services best decreases alcohol use among patients with HCV.
For people infected with hepatitis C virus (HCV), alcohol use increases the risk of
hepatocellular carcinoma and progressive liver fibrosis, which can lead to cirrhosis and
liver-related mortality. Integrated models of care that incorporate treatment for alcohol
use, substance use, and mental health comorbidities have been called for, but few empirically
tested models exist.
In an R21 study, we developed and manualized an integrated behavioral-medical treatment model
for patients with HCV who consume alcohol. Investigators successfully implemented a
standardized alcohol screening in a liver clinic using the Alcohol Use Disorders
Identification Test (AUDIT) instrument; recruited 60 patients; retained participants in group
and individual therapy; integrated care between an addictions therapist and medical
providers; and achieved an 85% six-month interview response rate. The alcohol abstinence rate
improved from 0% at baseline to 44% at 6 months. Mean Addiction Severity Index scores were
reduced by 50% for alcohol from .24 to .12, and decreased for drug use from .05 to .03. The
percentage of heavy drinkers decreased from 47% to 24% (Proeschold-Bell et al., 2011).
This study will conduct a randomized controlled trial that compares medical
provider-delivered brief alcohol counseling plus our on-site six-month integrated treatment
to brief alcohol counseling plus outside alcohol treatment referral in 279 HCV-infected
patients with qualifying AUDIT alcohol scores at baseline. Participants in both arms will be
treated at the Duke and UNC Liver Clinics and the Durham Veterans Affairs Medical Center.
Outcome variables will be assessed at baseline, 3, 6, and 12 months. The aims are to 1)
evaluate alcohol abstinence; 2) determine differences in secondary outcomes between study
arms; and 3) conduct a cost effectiveness analysis. Investigators hypothesize that the
intervention will significantly improve alcohol abstinence rates and significantly decrease
relapse rates compared to the comparison. Investigators further hypothesize that intervention
participants will report fewer drinks per week than comparison participants, have fewer
positive drug screens than comparison participants, and meet the $50,000 per quality-adjusted
life year gained standard established in the health economics literature.
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