Hepatitis C Alcohol Reduction Treatment (HepART-RCT)
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|ClinicalTrials.gov Identifier: NCT02176980|
Recruitment Status : Completed
First Posted : June 27, 2014
Last Update Posted : October 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C, Chronic; AUD||Behavioral: Brief alcohol counseling Behavioral: Group and Individual Therapy Sessions||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||182 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hepatitis C Alcohol Reduction Treatment - Randomized Controlled Trial (Hep ART-RCT)|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||September 30, 2018|
|Actual Study Completion Date :||September 30, 2018|
Active Comparator: Medical provider (MP) brief alcohol counseling & referral
Behavioral: Brief alcohol counseling
Medical provider gives feedback on how the patient's alcohol use may affect their current and future health, noting that it is the patient's responsibility to change behavior; giving advice to stop drinking based on medical concern; giving a menu of options for cutting down on drinking; expressing empathy; and reinforcing the patient's self-efficacy to change.
Experimental: Brief alcohol counseling & 6 months of HCV-alcohol treatment
Behavioral: Group and Individual Therapy Sessions
Session content integrates HCV and alcohol issues in treatment, liver health, and personal realms. Sessions include psychoeducational content on how alcohol affects the liver among people with HCV; HCV stigma; family issues around drinking and the HCV diagnosis; nutrition; life goals and positive affect; and alcohol reduction strategies.
- Alcohol abstinence rates at 6 months after consent [ Time Frame: 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.
- Relapse rate at 12 months after consent [ Time Frame: 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.
- Other alcohol use indicators [ Time Frame: 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.
- Illicit drug use [ Time Frame: 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.
- Cost effectiveness analysis of the intervention versus brief alcohol counseling and referral out [ Time Frame: 12 months ]The incremental cost-effectiveness ratio (ICER) will be absolute difference in costs divided by the absolute difference in various effectiveness measures between the 2 interventions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02176980
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Andrew Muir, MD||Duke University|