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Trial record 30 of 126 for:    "Viral Infectious Disease" | "Ethanol"

Hepatitis C Alcohol Reduction Treatment (HepART-RCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02176980
Recruitment Status : Completed
First Posted : June 27, 2014
Last Update Posted : October 18, 2018
University of North Carolina, Chapel Hill
Durham VA Medical Center
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic; AUD Behavioral: Brief alcohol counseling Behavioral: Group and Individual Therapy Sessions Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Medical provider (MP) brief alcohol counseling & referral
  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.
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
  • 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.
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Other Outcome Measures:
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

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 identifier (NCT number): NCT02176980

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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
University of North Carolina, Chapel Hill
Durham VA Medical Center
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Principal Investigator: Andrew Muir, MD Duke University

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Responsible Party: Duke University Identifier: NCT02176980     History of Changes
Other Study ID Numbers: Pro00046518
First Posted: June 27, 2014    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Keywords provided by Duke University:
hepatitis C
integrated care
Additional relevant MeSH terms:
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Virus Diseases
RNA Virus Infections
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections
Hepatitis, Chronic
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs