RCT of an Integrated Treatment of Persons with Co-occurring HCV and Alcohol Abuse
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. We successfully implemented a standardized alcohol screening in a hepatology 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 specialist 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).
We are conducting a randomized controlled trial that compares our six-month integrated treatment versus brief alcohol counseling in 230 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. We hypothesize that the intervention will significantly improve alcohol abstinence rates and significantly decrease relapse rates compared to the comparison. We further hypothesize that intervention participants will report fewer drinks per week and less illicit drug use 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.