<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01711125</url>
  </required_header>
  <id_info>
    <org_study_id>X11-0154</org_study_id>
    <nct_id>NCT01711125</nct_id>
  </id_info>
  <brief_title>Baclofen in the Treatment of Alcohol Dependence With or Without Alcoholic Liver Disease</brief_title>
  <acronym>BacALD</acronym>
  <official_title>Exploring the Efficacy and Biobehavioural Basis of Baclofen in the Treatment of Alcoholic Liver Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>South West Sydney Local Health District</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Health and Medical Research Council, Australia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Sydney</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>South West Sydney Local Health District</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To explore the effectiveness and biobehavioural basis of baclofen in improving treatment&#xD;
      outcomes for alcohol dependence in people with or without alcoholic cirrhosis in a&#xD;
      double-blind randomised placebo-controlled trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double-blind randomised placebo-controlled study investigating the efficacy of&#xD;
      baclofen for the treatment of alcohol dependence in patients with alcoholic liver disease.&#xD;
      Medications will be given for 12 weeks, with a further 6 months follow-up. Both male and&#xD;
      female participants will be recruited to this study. Trial patients will be randomised to one&#xD;
      of three treatment groups: (1) baclofen 30mg/day (10 mg t.i.d), (2) baclofen 75mg/day (25 mg&#xD;
      t.i.d) or (3) Placebo (3 matched tabs/day).&#xD;
&#xD;
      This study will also include a second, parallel group of patients with alcohol dependence&#xD;
      (non alcoholic-liver disease patients) that will undergo the trial protocol as described&#xD;
      above. These patients will be randomised according to a separate list into one of three&#xD;
      treatment groups: (1) baclofen 30mg/day (10 mg t.i.d), (2) baclofen 75mg/day (25 mg t.i.d) or&#xD;
      (3) Placebo (3 matched tabs/day).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>alcohol consumption</measure>
    <time_frame>12 weeks</time_frame>
    <description>as measured by the number of days abstinent, number of heavy drinking days, time to relapse, time to lapse and number of drinks per drinking day</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinical markers of liver injury</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of hepatic side effects</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>craving for alcohol</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>early termination due to side effects</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Alcoholic Liver Disease</condition>
  <condition>Alcohol Dependence</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Baclofen low dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Baclofen high dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Baclofen 30mg/day</intervention_name>
    <description>30mg/day 10 mg t.i.d</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Baclofen 75mg/day</intervention_name>
    <description>75mg/day 25 mg t.i.d</description>
    <arm_group_label>Arm 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo 3 matched tabs/day</description>
    <arm_group_label>Arm 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ALD (for trial group 1), defined as the presence of symptoms and/or signs referable to&#xD;
             liver disease with or without cirrhosis, in which alcohol use is considered to play a&#xD;
             major aetiological role. Alcohol use will have exceeded an average of 60g/day in women&#xD;
             and 80g/day in men for &gt;10 years.&#xD;
&#xD;
          -  Alcohol dependence according to the ICD-10 criteria (for both trial 1 and 2)&#xD;
&#xD;
          -  Adequate cognition and English language skills to give valid consent and complete&#xD;
             research interviews&#xD;
&#xD;
          -  Willingness to give written informed consent&#xD;
&#xD;
          -  Abstinence from alcohol for between 3 and 21 days&#xD;
&#xD;
          -  Resolution of any clinically evident alcohol withdrawal (CIWA-AR)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active major psychological disorder associated with psychosis or significant suicide&#xD;
             risk&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Concurrent use of any psychotropic medication other than antidepressants&#xD;
&#xD;
          -  Substance use other than nicotine if unstable&#xD;
&#xD;
          -  Clinical evidence of persisting hepatic encephalopathy&#xD;
&#xD;
          -  Pending incarceration&#xD;
&#xD;
          -  Lack of stable housing&#xD;
&#xD;
          -  Active peptic ulcers&#xD;
&#xD;
          -  Unstable diabetes mellitus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul S Haber, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sydney Local Health District</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andrew Baillie, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Macquarie University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kirsten C Morley, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sydney</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Drug Health Services, Royal Prince Alfred Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>South West Sydney Local Health District</investigator_affiliation>
    <investigator_full_name>Professor Paul Haber</investigator_full_name>
    <investigator_title>Clinica Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Liver Diseases, Alcoholic</mesh_term>
    <mesh_term>Alcoholism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Baclofen</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01711125
org study id: X11-0154
nct id: NCT01711125
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
To explore the effectiveness and biobehavioural basis of baclofen in improving treatment
      outcomes for alcohol dependence in people with or without alcoholic cirrhosis in a
      double-blind randomised placebo-controlled trial.
This is a double-blind randomised placebo-controlled study investigating the efficacy of
      baclofen for the treatment of alcohol dependence in patients with alcoholic liver disease.
      Medications will be given for 12 weeks, with a further 6 months follow-up. Both male and
      female participants will be recruited to this study. Trial patients will be randomised to one
      of three treatment groups: (1) baclofen 30mg/day (10 mg t.i.d), (2) baclofen 75mg/day (25 mg
      t.i.d) or (3) Placebo (3 matched tabs/day).

      This study will also include a second, parallel group of patients with alcohol dependence
      (non alcoholic-liver disease patients) that will undergo the trial protocol as described
      above. These patients will be randomised according to a separate list into one of three
      treatment groups: (1) baclofen 30mg/day (10 mg t.i.d), (2) baclofen 75mg/day (25 mg t.i.d) or
      (3) Placebo (3 matched tabs/day).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: alcohol consumption
time frame: 12 weeks
description: as measured by the number of days abstinent, number of heavy drinking days, time to relapse, time to lapse and number of drinks per drinking day
measure: clinical markers of liver injury
time frame: 12 weeks
measure: incidence of hepatic side effects
time frame: 12 weeks
measure: craving for alcohol
time frame: 12 weeks
measure: early termination due to side effects
time frame: 12 weeks
arm group label: Arm 1
arm group type: Experimental
description: Baclofen low dose
arm group label: Arm 2
arm group type: Experimental
description: Baclofen high dose
arm group label: Arm 3
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: Baclofen 30mg/day
description: 30mg/day 10 mg t.i.d
arm group label: Arm 1
intervention type: Drug
intervention name: Baclofen 75mg/day
description: 75mg/day 25 mg t.i.d
arm group label: Arm 2
intervention type: Drug
intervention name: Placebo
description: Placebo 3 matched tabs/day
arm group label: Arm 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Paul S Haber, MBBS
role: Principal Investigator
affiliation: Sydney Local Health District
last name: Andrew Baillie, PhD
role: Principal Investigator
affiliation: Macquarie University
last name: Kirsten C Morley, PhD
role: Principal Investigator
affiliation: University of Sydney
facility: 
country: Australia
responsible party type: Principal Investigator
investigator affiliation: South West Sydney Local Health District
investigator full name: Professor Paul Haber
investigator title: Clinica Director
mesh term: Liver Diseases
mesh term: Liver Diseases, Alcoholic
mesh term: Alcoholism
mesh term: Baclofen