Hepatitis CPhase 2NIAAANCT00958763
Alcohol Use Reduction in Methadone Individuals With Hepatitis C Virus(HCV)
A Phase 2 study testing Motivational Interviewing, Single - MIS and Motivational Interviewing Group in people with Hepatitis C, run by University of California, Los Angeles at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Motivational Interviewing, Single - MIS and Motivational Interviewing Group
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2006to Dec 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Matrix Institute
Los Angeles, California, 90016
Bay Area Addiction Research & Treatment, Inc (BAART)
Los Angeles, California, 90057
Tri-City Institute
Los Angeles, California, 90061
About this study
Official title: Alcohol Use Reduction in Methadone Individuals With HCV
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.
Read the 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.
- Conditions
- Hepatitis C
- Being tested
- Motivational Interviewing, Single - MIS, Motivational Interviewing Group, Usual Care Group - UCG
- Keywords
- HCV, Alcohol, Methadone Maintained
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing, Single - MISBehavioural
Also called MIS
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.
Motivational Interviewing GroupBehavioural
Also called MIG
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.
Usual Care Group - UCGOther
Also called UCG
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
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing, Single - MIS | Experimental | Not described Receives: Behavioral: Motivational Interviewing, Single - MIS |
| Motivational Interviewing, Group - MIG | Experimental | Not described Receives: Behavioral: Motivational Interviewing Group |
| Usual Care Group - UCG | Other | Not described Receives: Other: Usual Care Group - UCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startMar 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Investigators
- Adeline Nyamathi, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958763
- Sponsor's protocol ID
- G051003101
- Acronym
- NIAAA
- Status last verified
- Aug 2009
- First submitted
- 12 Aug 2009
- Last updated
- 13 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Use Reduction in Methadone Individuals With HCV
- ClinicalTrials.gov ID
- NCT00958763
- Acronym / sponsor ID
- NIAAA / G051003101
- Conditions
- Hepatitis C
- Keywords
- HCV, Alcohol, Methadone Maintained
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 13 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing, Single - MIS | Experimental | Behavioral: Motivational Interviewing, Single - MIS |
| Motivational Interviewing, Group - MIG | Experimental | Behavioral: Motivational Interviewing Group |
| Usual Care Group - UCG | Other | Other: Usual Care Group - UCG |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interviewing, Single - MISAlso: MISThe 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. | Behavioural | Motivational Interviewing, Single - MIS |
| Motivational Interviewing GroupAlso: MIGThe 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. | Behavioural | Motivational Interviewing, Group - MIG |
| Usual Care Group - UCGAlso: UCGThe 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 | Other | Usual Care Group - UCG |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adeline Nyamathi, PhD principal investigator
University of California, Los Angeles
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Motivational Interviewing, Single - MIS and Motivational Interviewing Group in people with Hepatitis C, run by University of California, Los Angeles at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2009.