Alcohol Use Reduction in Methadone Individuals With Hepatitis C Virus(HCV)
NIAAA
1 other identifier
interventional
219
1 country
3
Brief Summary
The Alcohol Use Reduction in Methadone Individuals with HCV was designed to compare three different types of programs for methadone maintained men and women to determine which of the three programs is most effective for:1) reducing alcohol consumption; 2) improving knowledge of and attitudes toward the disease of hepatitis and the treatment of hepatitis; 3) improving willingness to seek medical care for hepatitis C; 4) completing the 3 sessions on alcohol use reduction; 5) completing the 3 session Hepatitis A and B vaccine; and 6) determining the number of self-reported 12 step alcohol treatment program sessions attended.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2006
Typical duration for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 12, 2009
CompletedFirst Posted
Study publicly available on registry
August 13, 2009
CompletedAugust 13, 2009
August 1, 2009
2.8 years
August 12, 2009
August 12, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compare two Motivational Interviewing (MI) groups with the Usual Care group at six-month follow-up on reduction of alcohol use, and determine whether group MI delivery is as effective as individual MI delivery in relation to decreased alcohol use
2 years
Secondary Outcomes (1)
Determine whether there are differential rates of attendance in the programs, and, for eligible participants, contrast the three groups on completion of the HAV/HBV vaccination series, and number of self-reported visits to 12-step alcohol programs.
2 years
Study Arms (3)
Motivational Interviewing, Single - MIS
EXPERIMENTALMotivational Interviewing, Group - MIG
EXPERIMENTALUsual Care Group - UCG
OTHERInterventions
The Motivational Interviewing Single Arm is delivered individually to participants in 3 separate sessions to address a specific concept (alcohol use, cravings and what to do with them, and concomitant behaviors and/or consequences of alcohol use). Participants will be encouraged to explore the pros and cons for each of these topics with the facilitator, who will remain non-judgmental. Participants who are eligible for the Hepatitis A/B vaccine are also offered the vaccine in conjunction with each session.
The Motivational Interviewing Group Arm is delivered to participants in groups in 3 separate sessions to address a specific concept (alcohol use, cravings and what to do with them, and concomitant behaviors and/or consequences of alcohol use). Participants will be encouraged to explore the pros and cons for each of these topics with the facilitator and with the group, who will remain non-judgmental. Participants who are eligible for the Hepatitis A/B vaccine are also offered the vaccine in conjunction with each session.
The Usual Care Arm is delivered to participants in three brief time-equivalent health promotion sessions. Each session focuses on health promoting activities such as the importance of diet and exercise, need for physical and mental health assessment and enhanced coping for those afflicted with a history of drug and alcohol addiction. In addition participants receive liver health promotion education. Participants are also provided referrals to alcohol treatment programs in the community and offered the 3 series hepatitis A/B vaccine
Eligibility Criteria
You may qualify if:
- Eligible participants will be 18 - 55 years of age, enrolled at the participating methadone maintenance clinic for the past 2 months, and moderate to heavy alcohol users within the last 3 months
You may not qualify if:
- Individuals who are not within the age range, have not been enrolled in a methadone maintenance clinic for the past 2 months and were not moderate to heavy alcohol users within the last 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Matrix Institute
Los Angeles, California, 90016, United States
Bay Area Addiction Research & Treatment, Inc (BAART)
Los Angeles, California, 90057, United States
Tri-City Institute
Los Angeles, California, 90061, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adeline Nyamathi, PhD
University of California, Los Angeles
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 12, 2009
First Posted
August 13, 2009
Study Start
March 1, 2006
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
August 13, 2009
Record last verified: 2009-08