NCT01008280

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2010

Longer than P75 for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2009

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 9, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

February 8, 2016

Status Verified

January 1, 2016

Enrollment Period

3.4 years

First QC Date

November 3, 2009

Results QC Date

April 22, 2015

Last Update Submit

January 11, 2016

Conditions

Hepatitis CAlcohol Use Disorders

Outcome Measures

Primary Outcomes (3)

  • Number of Drinking Days in the Past Two Weeks

    12 Weeks

  • Number of Drinks Consumed Per Two Week Segments

    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

    12 weeks

Study Arms (2)

Baclofen

EXPERIMENTAL

baclofen 10 mg po tid

Drug: baclofen

Placebo

PLACEBO COMPARATOR

placebo given tid

Drug: placebo

Interventions

baclofenDRUG

baclofen 10 mg tid

Baclofen
placeboDRUG

placebo pill tid

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • 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
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, 90822, United States

Location

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

VA Medical Center, Minneapolis

Minneapolis, Minnesota, 55417, United States

Location

VA Medical Center, Portland

Portland, Oregon, 97201, United States

Location

MeSH Terms

Conditions

Hepatitis CAlcoholism

Interventions

Baclofen

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Results Point of Contact

Title
Peter Hauser, MD, VISN 22 Mental Health Services Lead
Organization
VISN 22 Network Office
peter.hauser2@va.gov
562 826 8000

Study Officials

  • Peter Hauser, MD

    VA Long Beach Healthcare System, Long Beach, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2009

First Posted

November 5, 2009

Study Start

October 1, 2010

Primary Completion

March 1, 2014

Study Completion

September 1, 2015

Last Updated

February 8, 2016

Results First Posted

June 9, 2015

Record last verified: 2016-01

Locations

US(4)