Hepatitis CPhase 4BRACNCT01008280
Baclofen to Reduce Alcohol Use in Veterans With HCV
A Phase 4 study testing baclofen in people with Hepatitis C and Alcohol Use Disorders, run by VA Office of Research and Development at 4 sites in United States.
Trial summary
Hepatitis C (HCV) is the most common blood born virus in the United States, affecting 1.8% of the general population and more than 5% of Veterans using VA facilities. As Veterans with HCV have high rates of co-morbid alcohol use disorders that accelerate greatly the liver damage caused by HCV, a safe and effective… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Alcohol Use Disorders
- What is being tested?
- baclofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2010to Sep 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Criteria for Participation Include if:
- Male or female
- Age 18 or older
- Medical record shows:
- Serum antibody positive for HCV and PCR (Polymerase Chain Reaction) confirmation, Men or Women: > 7 drinks per week for each of the proceeding 2 weeks Or One heavy drinking day per week for 2 weeks (Heavy drinking day: 5 drinks in one day for men and >4 drinks in one day for women) based on Timeline Followback method (TLFB)
- Alcohol use Disorder (abuse or dependence) based on Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (SCID)
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- Yes Medical record and self report
- Medical record, self report, SCID, Beck Depression Inventory -II (BDI-II)
- Able to attend clinic appointments
- Yes No Self-report
Who cannot join
- Criteria for Participation Exclude if:
- Male or female
- Under age 18
- Cocaine, methamphetamine or opioid dependence within the past 6 months*
- Any known pre-existing medical conditions that could interfere with participation in the protocol, such as:
- Central Nervous System (CNS) trauma
Show all 20Show fewer
- Known cognitive impairment
- Dementia
- Encephalopathy from liver disease
- Acute psychiatric instability, such as significant psychosis, mania, or elevated risk for suicide
- Not able to attend clinic appointments
- Pregnant women
- If any of the following medication are being used:
- Ondansetron
- Disulfiram
- Topiramate
- Naltrexone
- Acamprosate
- Buprenorphine
- Methadone
Trial locations and contacts
4 sites in 1 country.
United States4 sites
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822
VA Medical Center, Minneapolis
Minneapolis, Minnesota, 55417
VA Medical Center, Portland
Portland, Oregon, 97201
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
About this study
Official title: Efficacy & Safety of Baclofen to Reduce Alcohol Use in Veterans With HCV
Hepatitis C (HCV) is the most common blood born virus in the United States, affecting 1.8% of the general population and more than 5% of Veterans using VA facilities. As Veterans with HCV have high rates of co-morbid alcohol use disorders that accelerate greatly the liver damage caused by HCV, a safe and effective treatment for alcohol use disorders is needed. Baclofen is a novel treatment for alcohol use disorders that has minimal effect on the liver and may represent a safe and efficacious treatment option for Veterans with HCV and co-morbid alcohol use disorders.
Read the detailed description
Project: Efficacy of baclofen in reducing alcohol consumption in Veterans with HCV Principal Investigator: Peter Hauser, MD
Keywords: Hepatitis C, Substance-Related Disorders, Alcoholism
Abstract
PLAN/METHODS: Two sites of the national VA Hepatitis C Resource Center, including Minneapolis and Portland VA Medical Centers (VAMCs), the Long Beach VAMC, and the San Diego VAMC (total 4 sites) will recruit 180 men, women, and minority Veterans who are HCV positive and currently drinking alcohol. Participants will be assessed for current alcohol use and alcohol use disorders and enrolled in the study if they meet eligibility criteria, mainly that they are drinking more than 7 drinks a week or have one heavy drinking day a week for the preceding two weeks. Enrolled subjects will be randomly assigned to one of two groups: Experimental group (Baclofen) or control (placebo). Subjects will be followed for a total of 14 weeks, and follow-up data will be collected at a total of 11 visits (weeks 1,2,3,4,6,8,10,12, and 14). At each visit, interviews will be conducted by a blinded interviewer assessing current stage of change and current alcohol use along with any changes in mood and psychological or somatic symptoms. HCV viral titers will be obtained at baseline and again at week 12 to determine the effect of abstinence on this measure. Data will also be collected from participants' medical records regarding enrollment and attendance in substance abuse treatment or self-help programs (Alcoholics Anonymous). Data will be analyzed using repeated measure ANOVAs to compare the groups on alcohol use and stage of change.
CLINICAL RELEVANCE: This study focuses on a current Veterans Health Administration (VHA) priority: treatment of Veterans with HCV. Alcohol use in this population is a major risk factor for progression of liver disease. The investigators anticipate that the Baclofen proposed in this study will result in reduced alcohol use, which is expected to result in a slowing of the progression of liver disease, improvement in physical health, and a reduction in long-term service utilization and mortality rates.
POTENTIAL IMPACT ON VETERANS HEALTH CARE: Effectively addressing alcohol use disorders in a hepatitis clinic will contribute to a new standard of care for HCV patients within the VA. Co-located care for patients with comorbid medical and substance use disorders is likely to improve access to effective treatment, acceptance by patients and improve clinical efficiency.
- Conditions
- Hepatitis C, Alcohol Use Disorders
- Being tested
- baclofen, placebo
- Medical subject headings
- Hepatitis C, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
baclofenDrug
baclofen 10 mg tid
placeboDrug
placebo pill tid
| Study group | Role | What they receive |
|---|---|---|
| Baclofen | Experimental | baclofen 10 mg po tid Receives: Drug: baclofen |
| Placebo | Placebo comparator | placebo given tid Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Drinking Days in the Past Two Weeks
Measured: 12 Weeks
Number of Drinks Consumed Per Two Week Segments
Measured: 12 weeks
Number of Heavy Drinking Days Per Two Week Segment
A heavy drinking day was defined as ≥4 drinks/ day if female or ≥5 drinks/day if male
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2009 (estimated)
- Study startOct 2010
- Primary completionMar 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Peter Hauser, MD, Principal investigator, VA Long Beach Healthcare System, Long Beach, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008280
- Sponsor's protocol ID
- NURA-014-09S
- Acronym
- BRAC
- Status last verified
- Jan 2016
- First submitted
- 3 Nov 2009
- Last updated
- 8 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy & Safety of Baclofen to Reduce Alcohol Use in Veterans With HCV
- ClinicalTrials.gov ID
- NCT01008280
- Acronym / sponsor ID
- BRAC / NURA-014-09S
- Conditions
- Hepatitis C, Alcohol Use Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Oct 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 5 Nov 2009 (estimated)
- Results
- Posted 9 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hepatitis C (HCV) is the most common blood born virus in the United States, affecting 1.8% of the general population and more than 5% of Veterans using VA facilities. As Veterans with HCV have high rates of co-morbid alcohol use disorders that accelerate greatly the liver damage caused by HCV, a safe and effective treatment for alcohol use disorders is needed. Baclofen is a novel treatment for alcohol use disorders that has minimal effect on the liver and may represent a safe and efficacious treatment option for Veterans with HCV and co-morbid alcohol use disorders.
Detailed description
Project: Efficacy of baclofen in reducing alcohol consumption in Veterans with HCV Principal Investigator: Peter Hauser, MD
Keywords: Hepatitis C, Substance-Related Disorders, Alcoholism
Abstract
PLAN/METHODS: Two sites of the national VA Hepatitis C Resource Center, including Minneapolis and Portland VA Medical Centers (VAMCs), the Long Beach VAMC, and the San Diego VAMC (total 4 sites) will recruit 180 men, women, and minority Veterans who are HCV positive and currently drinking alcohol. Participants will be assessed for current alcohol use and alcohol use disorders and enrolled in the study if they meet eligibility criteria, mainly that they are drinking more than 7 drinks a week or have one heavy drinking day a week for the preceding two weeks. Enrolled subjects will be randomly assigned to one of two groups: Experimental group (Baclofen) or control (placebo). Subjects will be followed for a total of 14 weeks, and follow-up data will be collected at a total of 11 visits (weeks 1,2,3,4,6,8,10,12, and 14). At each visit, interviews will be conducted by a blinded interviewer assessing current stage of change and current alcohol use along with any changes in mood and psychological or somatic symptoms. HCV viral titers will be obtained at baseline and again at week 12 to determine the effect of abstinence on this measure. Data will also be collected from participants' medical records regarding enrollment and attendance in substance abuse treatment or self-help programs (Alcoholics Anonymous). Data will be analyzed using repeated measure ANOVAs to compare the groups on alcohol use and stage of change.
CLINICAL RELEVANCE: This study focuses on a current Veterans Health Administration (VHA) priority: treatment of Veterans with HCV. Alcohol use in this population is a major risk factor for progression of liver disease. The investigators anticipate that the Baclofen proposed in this study will result in reduced alcohol use, which is expected to result in a slowing of the progression of liver disease, improvement in physical health, and a reduction in long-term service utilization and mortality rates.
POTENTIAL IMPACT ON VETERANS HEALTH CARE: Effectively addressing alcohol use disorders in a hepatitis clinic will contribute to a new standard of care for HCV patients within the VA. Co-located care for patients with comorbid medical and substance use disorders is likely to improve access to effective treatment, acceptance by patients and improve clinical efficiency.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baclofen | Experimental | Drug: baclofenbaclofen 10 mg po tid |
| Placebo | Placebo comparator | Drug: placeboplacebo given tid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female
- Age 18 or older
- Serum antibody positive for HCV and PCR (Polymerase Chain Reaction) confirmation, Men or Women: > 7 drinks per week for each of the proceeding 2 weeks Or One heavy drinking day per week for 2 weeks (Heavy drinking day: 5 drinks in one day for men and >4 drinks in one day for women) based on Timeline Followback method (TLFB)
- Alcohol use Disorder (abuse or dependence) based on Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (SCID)
Key exclusion criteria (20 listed)
- Male or female
- Under age 18
- Cocaine, methamphetamine or opioid dependence within the past 6 months*
- Any known pre-existing medical conditions that could interfere with participation in the protocol, such as:
- Not able to attend clinic appointments
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 |
|---|---|---|
| baclofenbaclofen 10 mg tid | Drug | Baclofen |
| placeboplacebo pill tid | Drug | Placebo |
Primary outcome
Number of Drinking Days in the Past Two Weeks
Time frame: 12 Weeks
Number of Drinks Consumed Per Two Week Segments
Time frame: 12 weeks
Number of Heavy Drinking Days Per Two Week Segment
Time frame: 12 weeks
A heavy drinking day was defined as ≥4 drinks/ day if female or ≥5 drinks/day if male
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Peter Hauser, MD principal investigator
VA Long Beach Healthcare System, Long Beach, CA
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing baclofen in people with Hepatitis C and Alcohol Use Disorders, run by VA Office of Research and Development at 4 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 10 inclusion and 20 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 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Drinking Days in the Past Two Weeks (time frame: 12 Weeks). The study lists 3 primary outcomes in all. 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 8 Feb 2016.