Clinical trial NCT00958763: Alcohol Use Reduction in Methadone Individuals With Hepatitis C Virus(HCV)
Official title: Alcohol Use Reduction in Methadone Individuals With HCV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Keywords: HCV
Alcohol
Methadone Maintained
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2009-08-13
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 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
timeFrame: 2 years
Secondary outcomes:
measure: 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.
timeFrame: 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Matrix Institute
state: California
city: Los Angeles
country: United States
facility: Bay Area Addiction Research & Treatment, Inc (BAART)
state: California
city: Los Angeles
country: United States
facility: Tri-City Institute
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Adeline Nyamathi, PhD
role: PRINCIPAL_INVESTIGATOR
References: