N/A
N=139
Study of the Effects of Motivational Enhancement Therapy on Alcohol Use in Chronic Hepatitis C Patients
Alcohol Dependence · Chronic Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT00596960 ↗Enrolled (actual)
139
Serious AEs
15.1%
Results posted
Nov 2014
Primary outcome: Primary: The Number of Alcohol Drinks Per Week (as Measured by the Time Line Follow Back Procedure) at the 6 Month Follow-up. — 14.88; 21.41 Standard Alcohol drinks
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Motivational Enhancement Therapy (MET) (Behavioral); Health education (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Alcohol Drinks Per Week (as Measured by the Time Line Follow Back Procedure) at the 6 Month Follow-up. |
14.88; 21.41 | — |
| PRIMARY Percent Days Abstinent From Alcohol at 6 Months |
73.15; 59.49 | — |
| SECONDARY Heavy Drinking Days (Greater or Equal to 4 Drinks) |
5.10; 7.38 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00596960). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.