Study of the Effects of Motivational Enhancement Therapy on Alcohol Use in Chronic Hepatitis C Patients

Chronic Hepatitis C Clinical Trial

Official title:

Motivating Chronic Hepatitis C Patients to Reduce Alcohol Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00596960
• Other study ID #: NEUA-009-07S
• Status: Completed
• Phase: N/A
• First received: January 8, 2008
• Last updated: November 26, 2014
• Start date: November 2008
• Est. completion date: July 2012

Study information

• Verified date: November 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Behavioral:
• Motivational Enhancement Therapy (MET)
MET is a 4 session intervention based on motivational approaches that was successful in project MATCH.
• Health education
Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training.

Locations

Country	Name	City	State
United States	Minneapolis VA Health Care System	Minneapolis	Minnesota
United States	VA Medical Center, Portland	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Alcohol Drinks Per Week (as Measured by the Time Line Follow Back Procedure) at the 6 Month Follow-up.	A standard drink was considered 14 oz. of alcohol or12 oz of regular beer, 5 oz of regular wine, or 1.5 oz of distilled spirits. The number of drinks per week was measured for 30 a day time frame at baseline, 3 months and 6-months.	6-months	No
Primary	Percent Days Abstinent From Alcohol at 6 Months	Alcohol use was measured for 30 days at baseline, 3-months and 6-months using the time-line follow back method. Percent days abstinent was measured by determining: days abstinent/30days X 100=%days abstinent.	6-months	No
Secondary	Heavy Drinking Days (Greater or Equal to 4 Drinks)	This was measured as heavy drinking days per 30 day time frame. A standard drink was considered 14 oz. of alcohol or12 oz of regular beer, 5 oz of regular wine, or 1.5 oz of distilled spirits. A heavy drinking day was considered to be 4 or greater drinks during a day.	6-months	No