Hepatitis C Alcohol Reduction Treatment

Not Applicable

Completed

• Conditions: Hepatitis C, Chronic; AUD
• Interventions: Behavioral: Brief alcohol counseling; Behavioral: Group and Individual Therapy Sessions

• Registration Number: NCT02176980
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2014-06-26
• Study First Submitted QC: 2014-06-26
• Study First Posted: 2014-06-27
• Study Start: 2014-10
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-17
• Last Update Posted: 2018-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Medical provider (MP) brief alcohol counseling & referral	Brief alcohol counseling	1. Screening of HCV-infected patients for alcohol use using the 10-item Alcohol Use Disorders Identification Test (AUDIT). 2. Patients self-administer the AUDIT. 3. HCV providers review the AUDIT with the patient. 4. If the patient is using any alcohol, the HCV provider conducts brief alcohol counseling using the FRAMES model, based on the evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) method. 5. Medical provider will explain the importance of alcohol abstinence in the presence of HCV infection. 6. Patient is referred to an alcohol treatment programs outside the liver clinic. Typical counseling will take the form of individual and group therapy.
Brief alcohol counseling & 6 months of HCV-alcohol treatment	Group and Individual Therapy Sessions	* Steps 1 through 5 as described in comparator arm above. * 6 months of group therapy, offered weekly. * 6 months of individual therapy, in person or by phone, offered every two weeks. * Therapy content emphasizes interplay between alcohol use and liver health/HCV. * Informal collaboration between HCV providers and addictions therapists. * Shared EMR charting. * Referral to study-provided psychiatry as needed.

Primary Outcome Measures

Name	Time	Method
Alcohol abstinence rates at 6 months after consent	6 months	Investigators will compare the two treatment arms on occurrence and amount of past 180 days of drinking using the timeline follow-back method, allowing the investigators to assess change in number of drinking days, periods of abstinence, and total grams of alcohol consumed.

Secondary Outcome Measures

Name	Time	Method
Other alcohol use indicators	3, 6 and 12 months	At 3, 6 and 12 months, investigators will assess the number of heavy drinking days and grams of alcohol consumed and compare between the two treatment arms.
Relapse rate at 12 months after consent	12 months	Investigators will compare the two treatment arms on periods of abstinence and number of drinking days using the timeline follow-back method for the 180 days between 6 and 12 months since study consent.
Illicit drug use	3, 6 and 12 months	At 3, 6 and 12 months, investigators will assess illicit drug use based on positive/negative urine toxicology screens and compare between the two treatment arms.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States