Alcohol Dependence, Chronic Hepatitis C
Conditions
Keywords
Alcohol Abuse, Alcohol Dependence, Carbohydrate Deficient Transferrin, Drug Dependence, Hepatitis C, Motivation
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.
Interventions
BEHAVIORALMotivational Enhancement Therapy (MET)
MET is a 4 session intervention based on motivational approaches that was successful in project MATCH.
BEHAVIORALHealth 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.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Alcohol Drinks Per Week (as Measured by the Time Line Follow Back Procedure) at the 6 Month Follow-up. | 6-months | 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. |
| Percent Days Abstinent From Alcohol at 6 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heavy Drinking Days (Greater or Equal to 4 Drinks) | 6-months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Motivational enhancement therapy
Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH. | 70 |
| Arm 2 health education intervention
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. | 69 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 2 |
| Overall Study | Incarcerated | 2 | 0 |
| Overall Study | Lost to Follow-up | 6 | 5 |
| Overall Study | No alcohol use data | 0 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Arm 1 | Total | Arm 2 |
|---|---|---|---|
| Age, Continuous | 55.8 years STANDARD_DEVIATION 6.8 | 55.5 years STANDARD_DEVIATION 6.6 | 55.2 years STANDARD_DEVIATION 6.3 |
| Beck Depression Inventory-II | 17.40 units on a scale STANDARD_DEVIATION 11.58 | 17.36 units on a scale STANDARD_DEVIATION 11.16 | 17.31 units on a scale STANDARD_DEVIATION 10.79 |
| Brief Symptom Inventory | 51.23 units on a scale STANDARD_DEVIATION 41.23 | 54.05 units on a scale STANDARD_DEVIATION 42.66 | 56.91 units on a scale STANDARD_DEVIATION 44.18 |
| Mean standard drinks per week | 35.45 Standard drinks of alcohol STANDARD_DEVIATION 25.42 | 37.13 Standard drinks of alcohol STANDARD_DEVIATION 37.03 | 38.86 Standard drinks of alcohol STANDARD_DEVIATION 46.19 |
| Percentage of days abstinent | 34.98 percentage of days abstinent STANDARD_DEVIATION 26.7 | 34.81 percentage of days abstinent STANDARD_DEVIATION 26.8 | 34.63 percentage of days abstinent STANDARD_DEVIATION 27 |
| Posttraumatic stress disorder checklist - Civilian (PCL-C) | 38.01 units on a scale STANDARD_DEVIATION 15.21 | 39.28 units on a scale STANDARD_DEVIATION 15.62 | 40.61 units on a scale STANDARD_DEVIATION 16.04 |
| Race/Ethnicity, Customized African American | 20 participants | 41 participants | 21 participants |
| Race/Ethnicity, Customized Caucasian | 48 participants | 94 participants | 46 participants |
| Race/Ethnicity, Customized Native American | 0 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized Other | 2 participants | 2 participants | 0 participants |
| Region of Enrollment United States | 70 participants | 139 participants | 69 participants |
| Sex: Female, Male Female | 2 Participants | 6 Participants | 4 Participants |
| Sex: Female, Male Male | 68 Participants | 133 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 70 | 0 / 69 |
| serious Total, serious adverse events | 7 / 70 | 14 / 69 |
Outcome results
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.
Time frame: 6-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Percent Days Abstinent From Alcohol at 6 Months | 73.15 percentage of days abstinent | Standard Deviation 32.18 |
| Arm 2 | Percent Days Abstinent From Alcohol at 6 Months | 59.49 percentage of days abstinent | Standard Deviation 35.3 |
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.
Time frame: 6-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | The Number of Alcohol Drinks Per Week (as Measured by the Time Line Follow Back Procedure) at the 6 Month Follow-up. | 14.88 Standard Alcohol drinks | Standard Deviation 27.94 |
| Arm 2 | The Number of Alcohol Drinks Per Week (as Measured by the Time Line Follow Back Procedure) at the 6 Month Follow-up. | 21.41 Standard Alcohol drinks | Standard Deviation 29.39 |
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.
Time frame: 6-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Heavy Drinking Days (Greater or Equal to 4 Drinks) | 5.10 heavy drinking days | Standard Deviation 8.1 |
| Arm 2 | Heavy Drinking Days (Greater or Equal to 4 Drinks) | 7.38 heavy drinking days | Standard Deviation 9.53 |