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 propose 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 illict 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.

Public Health Relevance

Alcohol abstinence greatly improves outcomes for HCV-nfected patients. If effective, our 6-month treatment model may greatly improve the health of HCV-infected patients. In addition, alcohol abstinence is required for HCV treatment, including the new regimens which have higher sustained virologic response rates. Our intervention may help patients qualify for, and adhere to, their medication regimens. This study will also determine whether the 6-month treatment model or brief alcohol counseling is more cost effective

Agency
National Institute of Health (NIH)
Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Type
Research Project (R01)
Project #
1R01AA021133-01A1
Application #
8438085
Study Section
Health Services Research Review Subcommittee (AA)
Program Officer
Roach, Deidra
Project Start
2013-09-05
Project End
2018-05-31
Budget Start
2013-09-05
Budget End
2014-05-31
Support Year
1
Fiscal Year
2013
Total Cost
$711,317
Indirect Cost
$219,142
Name
Duke University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705