Alcohol Use Reduction in Methadone Individuals With Hepatitis C Virus(HCV) (NIAAA)
Primary Purpose
Hepatitis C
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing, Single - MIS
Motivational Interviewing Group
Usual Care Group - UCG
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis C focused on measuring HCV, Alcohol, Methadone Maintained
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Matrix Institute
- Bay Area Addiction Research & Treatment, Inc (BAART)
- Tri-City Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
Motivational Interviewing, Single - MIS
Motivational Interviewing, Group - MIG
Usual Care Group - UCG
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00958763
First Posted
August 12, 2009
Last Updated
August 12, 2009
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT00958763
Brief Title
Alcohol Use Reduction in Methadone Individuals With Hepatitis C Virus(HCV)
Acronym
NIAAA
Official Title
Alcohol Use Reduction in Methadone Individuals With HCV
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Nationwide, major strides have been made in treatment for HCV-infected patients using pegylated interferon and ribaviron; however use of these medications with HCV-infected opioid maintained (OM) IDUs in methadone maintenance (MM) treatment is problematic. Further, as many HCV-infected OM clients are continuing to drink alcohol, ongoing liver fibrosis and other social and behavioral consequences of alcohol use and abuse continue. Despite the fact that brief Motivational Interviewing (MI) has demonstrated effectiveness, these programs are not conducted in MM treatment settings. Moreover, the effectiveness of group delivery, as opposed to one-on-one delivery, of MI is unknown in terms of alcohol use reduction. In Phase I of this two-phased exploratory R21, a qualitative assessment will be conducted with 40 OM HCV-infected adults, 20 moderate alcohol users and 20 heavy alcohol users, equally divided by gender and readiness to change alcohol use, to explore with these clients: 1) factors impacting access to alcohol use reduction and health promotion services and free vaccination for HAV/HBV; and 2) strategies that MM staff can use to assist their clients in seeking services. Staff of a MM clinic will also explore the feasibility of providing these services. In Phase II, we plan to pilot an alcohol use reduction and liver health promotion intervention with 250 eligible, HCV-infected, alcohol-using OM clients receiving MM. Two intervention groups incorporating MI) will provide on-site brief MI (3 sessions) counseling to participants using either one-on-one delivery (MI-Single) or the group-delivery (MI-Group). In addition, each group will be offered the Liver Health Promotion (LHP) program, which includes a 30-minute health promotion education session, referral to a community 12-Step alcohol outpatient program, and an offer for free screening for HAV/HBV, and the HAV/HBV vaccination series, if eligible (defined as being HAV and/or HBV seronegative). All these services will be integrated within participants' usual MM clinic onsite services. A third group, the Usual Care (UC) group will receive the same components offered to the intervention groups except for a time balanced on-site brief 3 session health promotion counseling as opposed to the MI. The short-term goals of the proposed study are to refine strategies that can be fully tested in a large-scale intervention trial. The long-term goals are to contribute to knowledge about promoting alcohol-related health-seeking and treatment completion behaviors in MM clinic settings that serve OM HCV-positive clients, so that population-specific intervention strategies can be developed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
HCV, Alcohol, Methadone Maintained
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
219 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Motivational Interviewing, Single - MIS
Arm Type
Experimental
Arm Title
Motivational Interviewing, Group - MIG
Arm Type
Experimental
Arm Title
Usual Care Group - UCG
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing, Single - MIS
Other Intervention Name(s)
MIS
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing Group
Other Intervention Name(s)
MIG
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care Group - UCG
Other Intervention Name(s)
UCG
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adeline Nyamathi, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Matrix Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90016
Country
United States
Facility Name
Bay Area Addiction Research & Treatment, Inc (BAART)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Tri-City Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90061
Country
United States
12. IPD Sharing Statement
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Alcohol Use Reduction in Methadone Individuals With Hepatitis C Virus(HCV)
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