Clinical trial NCT00596960: Study of the Effects of Motivational Enhancement Therapy on Alcohol Use in Chronic Hepatitis C Patients
Official title: Motivating Chronic Hepatitis C Patients to Reduce Alcohol Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Dependence
Chronic Hepatitis C
Keywords: Alcohol Abuse
Alcohol Dependence
Carbohydrate Deficient Transferrin
Drug Dependence
Hepatitis C
Motivation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-01-17
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether motivational enhancement therapy (MET) reduces alcohol use in a population of HCV-infected veterans who are currently drinking alcohol and have alcohol disorders. We hypothesize that veterans with HCV, an alcohol use disorder and continued excessive alcohol use who receive MET will have a greater reduction in the number of standard alcohol drinks per week and a greater percentage of days abstinent than veterans who receive health education control intervention.

Detailed description: BACKGROUND: Recent studies suggest the presence of hepatitis C virus (HCV) among veterans treated within the Veterans Affairs Medical Center is 3 to 4 times more common than among the general population and approximately 50 to 60% of the patients are at risk for progression to end-stage liver disease. Alcohol use substantially increases the rate of liver disease progression. Alcohol treatment based on motivational principles has been found to be effective in alcohol treatment seeking individuals with low levels of psychiatric comorbidity. Effective treatments for alcohol use have not been studied in patients chronically infected with HCV, individuals who typically do not seek separate specialty care for alcohol problems. The primary purpose of this study is to determine the efficacy of motivational enhancement therapy (MET) in reducing alcohol use in a population of HCV-infected veterans who are currently drinking alcohol and have alcohol disorders. Secondarily this study is designed to determine whether changes in motivation predict changes in alcohol use; determine whether MET effects non-alcohol related behavior such as adherence to clinic appointments and the effects of a reduction in alcohol use on biomarkers of alcohol use and HCV viral load.

METHODS: Two sites of the national VA Hepatitis C Resource Center, including Minneapolis and Portland will enroll 136 men, women, and minority veterans who are HCV positive, have an alcohol use disorder and are currently drinking. Participants will be recruited from the hepatitis clinics at each site after they have received two sessions of care from hepatitis clinicians. Subjects will be eligible for enrollment in the study if they are drinking at least 7 drinks per week over the preceding 2-weeks. Participants will be randomly assigned to one of two groups: a 4-week session MET or a 4 session health education control intervention. Follow-up data will be collected at 3 and 6 month interviews by a blinded interviewer assessing current alcohol use. Secondary outcomes including stage of change, data regarding enrollment and attendance in separate substance abuse treatment or self-help programs (Alcoholics Anonymous) will be collected from participants' medical record. HCV viral titers will be obtained at baseline and 6-months. Percent CDT and ethyl glucuronide will be measured to confirm self-reported alcohol use at each study visit. The primary outcome (efficacy of MET in reducing alcohol use) data will be analyzed using mixed effect models if the data are normally distributed and generalized estimated equations if the data are non-normally distributed.

CLINICAL RELEVANCE: This study focuses on a current VHA priority: treatment of veterans with HCV. Alcohol use on this population is a major risk factor for progression of liver disease. We anticipate that the MET proposed in this study will result in a slowing of the progression of liver disease, improvement in physical health, and a reduction in long-term service utilization and mortality rates.

POTENTIAL IMPACT ON VETERANS HEALTH CARE: Effectively addressing alcohol use disorders in a hepatitis clinic will contribute to a new standard of care for HCV patients within VA. MET is a relatively brief, easily adaptable intervention that if effective is likely to improve access to alcohol treatment, acceptance by patients and improve clinical efficiency. In addition, reducing or eliminating alcohol use in this population has the potential to alter the course of liver disease progression, reducing the rates of cirrhosis, hepatocellular carcinoma and the need for liver transplantation.

Eligibility criteria: Inclusion Criteria:

* Male or Female age 18 or older
* Serum antibody and polymerase chain reaction positive for hepatitis C
* Drinking greater than 7 drinks for each of the proceeding 2 weeks or one day heavy drinking day per week for 2 week (heavy drinking day:\>4 drinks in one day)
* Diagnosed with alcohol abuse or dependence

Exclusion Criteria:

* Diagnosis of cocaine, methamphetamine or opioid dependence within the past 6 months
* Unable to attend clinic appointments
* Any known pre-existing medical conditions that could interfere with participation in the protocol, such as: CNS trauma, known cognitive impairment, dementia, encephalopathy from liver disease, acute psychiatric instability, such as significant psychosis, mania, or elevated risk for suicide

Primary outcomes:
measure: The Number of Alcohol Drinks Per Week (as Measured by the Time Line Follow Back Procedure) at the 6 Month Follow-up.
timeFrame: 6-months
measure: Percent Days Abstinent From Alcohol at 6 Months
timeFrame: 6-months
Secondary outcomes:
measure: Heavy Drinking Days (Greater or Equal to 4 Drinks)
timeFrame: 6-months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System
state: Minnesota
city: Portland
country: United States
facility: VA Medical Center, Portland
state: Oregon
Study officials:
affiliation: Minneapolis Veterans Affairs Medical Center
name: Eric W. Dieperink, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dieperink E, Fuller B, Isenhart C, McMaken K, Lenox R, Pocha C, Thuras P, Hauser P. Efficacy of motivational enhancement therapy on alcohol use disorders in patients with chronic hepatitis C: a randomized controlled trial. Addiction. 2014 Nov;109(11):1869-77. doi: 10.1111/add.12679. Epub 2014 Aug 14.