Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Department of Veterans Affairs |
---|---|
Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00596960 |
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 oer week and a greater percentage of days abstinent than veterans who receive health education control intervention.
Condition | Intervention |
---|---|
Alcohol Dependence Chronic Hepatitis C |
Behavioral: Motivational Enhancement Therapy (MET) Behavioral: Health education |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Motivating Chronic Hepatitis C Patients to Reduce Alcohol Use |
Estimated Enrollment: | 160 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | May 2011 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Motivational enhancement therapy
|
Behavioral: Motivational Enhancement Therapy (MET)
MET is a 4 session intervention based on motivational approaches that was sucessful in project MATCH.
|
2: Active Comparator
health education intervention
|
Behavioral: 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 hygeine, nutrition, exercise and relaxation training.
|
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 wil enroll 160 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. MEYT 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
CNS trauma, known cognitive impairment, dementia, encephalopathy from liver disease, acute psychiatric instability, such as significant psychosis, mania, or elevated risk for suicide
Contact: Kari Johnson, BS | (612) 467-4149 | johnson2@va.gov |
Contact: Eric Dieperink, MD | (612) 725-2000 ext 3964 | eric.dieperink@med.va.gov |
United States, Minnesota | |
Vamc (152/2E) | Recruiting |
Minneapolis, Minnesota, United States, 55417 | |
Contact: Eric Dieperink, MD 612-725-2000 ext 3964 eric.dieperink@med.va.gov | |
Principal Investigator: Eric Dieperink, MD | |
United States, Oregon | |
VA Medical Center, Portland | Recruiting |
Portland, Oregon, United States, 97201 | |
Contact: Ruth Q Leibowitz, PhD 503-220-8262 ext 54487 Ruth.Leibowitz1@va.gov |
Principal Investigator: | Eric Dieperink, MD | VAMC (152/2E) |
Responsible Party: | Department of Veterans Affairs ( Dieperink, Eric - Principal Investigator ) |
Study ID Numbers: | NEUA-009-07S |
Study First Received: | January 8, 2008 |
Last Updated: | June 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00596960 History of Changes |
Health Authority: | United States: Federal Government |
Alcohol Abuse Alcohol Dependence Carbohydrate Deficient Transferrin |
Drug Dependence Hepatitis C Motivation |
Liver Diseases Hepatitis, Chronic Disorders of Environmental Origin Hepatitis, Viral, Human Alcohol Drinking Virus Diseases Hepatitis Digestive System Diseases |
Mental Disorders Alcoholism Substance-Related Disorders Alcohol-Related Disorders Hepatitis C Hepatitis C, Chronic Ethanol |
RNA Virus Infections Liver Diseases Flaviviridae Infections Hepatitis, Chronic Disorders of Environmental Origin Hepatitis, Viral, Human Hepatitis Virus Diseases |
Digestive System Diseases Mental Disorders Alcoholism Substance-Related Disorders Alcohol-Related Disorders Hepatitis C Hepatitis C, Chronic |