Clinical trial NCT02176980: Hepatitis C Alcohol Reduction Treatment
Official title: Hepatitis C Alcohol Reduction Treatment - Randomized Controlled Trial (Hep ART-RCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C, Chronic; AUD
Keywords: HCV
hepatitis C
alcohol
integrated care
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: Durham VA Medical Center
First posted: 2014-06-27
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion criteria

* Ever HCV-infected chronic HCV
* Appropriate score on the Alcohol Use Disorder Identification Test (AUDIT)

  * Females, ≥4
  * Males, ≥8
* Consumed alcohol in past 60 days
* Not currently attending alcohol treatment services more than once every two weeks. If you attend treatment services at least once every two weeks, you must have either drunk alcohol heavily in the past 2 weeks or have drunk alcohol at least 7 of the past 14 days or your medical provider must have assessed that you would benefit from alcohol treatment services offered by this study

  \* Patient at one of the 3 clinic sites
* 18 or older
* English-speaking
* OK to have HIV, substance use or other co-morbidities, or receiving HCV antiviral treatment

Exclusion criteria

* Psychotic
* Insurmountable transportation barriers (can receive individual therapy by phone but need appointments with HCV provider at 3 and 6 months and ideally some in-person group therapy)

Primary outcomes:
measure: Alcohol abstinence rates at 6 months after consent
timeFrame: 6 months
Secondary outcomes:
measure: Relapse rate at 12 months after consent
timeFrame: 12 months
measure: Other alcohol use indicators
timeFrame: 3, 6 and 12 months
measure: Illicit drug use
timeFrame: 3, 6 and 12 months
Other outcomes:
measure: Cost effectiveness analysis of the intervention versus brief alcohol counseling and referral out
timeFrame: 12 months
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Andrew Muir, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Proeschold-Bell RJ, Patkar AA, Naggie S, Coward L, Mannelli P, Yao J, Bixby P, Muir AJ. An integrated alcohol abuse and medical treatment model for patients with hepatitis C. Dig Dis Sci. 2012 Apr;57(4):1083-91. doi: 10.1007/s10620-011-1976-4. Epub 2011 Dec 2.
citation: Proeschold-Bell RJ, Evon DM, Makarushka C, Wong JB, Datta SK, Yao J, Patkar AA, Mannelli P, Hodge T, Naggie S, Wilder JM, Fried MW, Niedzwiecki D, Muir AJ. The Hepatitis C-Alcohol Reduction Treatment (Hep ART) intervention: Study protocol of a multi-center randomized controlled trial. Contemp Clin Trials. 2018 Sep;72:73-85. doi: 10.1016/j.cct.2018.07.003. Epub 2018 Jul 10.