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Baclofen in the Treatment of Alcohol Dependence With or Without Alcoholic Liver Disease (BacALD)

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ClinicalTrials.gov Identifier: NCT01711125
Recruitment Status : Completed
First Posted : October 22, 2012
Last Update Posted : August 8, 2017
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
University of Sydney
Information provided by (Responsible Party):
Professor Paul Haber, South West Sydney Local Health District

Tracking Information
First Submitted Date  ICMJE October 16, 2012
First Posted Date  ICMJE October 22, 2012
Last Update Posted Date August 8, 2017
Study Start Date  ICMJE March 2013
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2013)
alcohol consumption [ Time Frame: 12 weeks ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 19, 2012)
alcohol consumption [ Time Frame: 12 weeks ]
as measured by the number of days abstinent, time to relapse, and number of drinks per drinking day
Change History Complete list of historical versions of study NCT01711125 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2012)
  • clinical markers of liver injury [ Time Frame: 12 weeks ]
  • incidence of hepatic side effects [ Time Frame: 12 weeks ]
  • craving for alcohol [ Time Frame: 12 weeks ]
  • early termination due to side effects [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Baclofen in the Treatment of Alcohol Dependence With or Without Alcoholic Liver Disease
Official Title  ICMJE Exploring the Efficacy and Biobehavioural Basis of Baclofen in the Treatment of Alcoholic Liver Disease
Brief Summary 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.
Detailed Description

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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Alcoholic Liver Disease
  • Alcohol Dependence
Intervention  ICMJE
  • Drug: Baclofen 30mg/day
    30mg/day 10 mg t.i.d
  • Drug: Baclofen 75mg/day
    75mg/day 25 mg t.i.d
  • Drug: Placebo
    Placebo 3 matched tabs/day
Study Arms  ICMJE
  • Experimental: Arm 1
    Baclofen low dose
    Intervention: Drug: Baclofen 30mg/day
  • Experimental: Arm 2
    Baclofen high dose
    Intervention: Drug: Baclofen 75mg/day
  • Placebo Comparator: Arm 3
    Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2017)
104
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2012)
120
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ALD (for trial group 1), defined as the presence of symptoms and/or signs referable to liver disease with or without cirrhosis, in which alcohol use is considered to play a major aetiological role. Alcohol use will have exceeded an average of 60g/day in women and 80g/day in men for >10 years.
  • Alcohol dependence according to the ICD-10 criteria (for both trial 1 and 2)
  • Adequate cognition and English language skills to give valid consent and complete research interviews
  • Willingness to give written informed consent
  • Abstinence from alcohol for between 3 and 21 days
  • Resolution of any clinically evident alcohol withdrawal (CIWA-AR)

Exclusion Criteria:

  • Active major psychological disorder associated with psychosis or significant suicide risk
  • Pregnancy or lactation
  • Concurrent use of any psychotropic medication other than antidepressants
  • Substance use other than nicotine if unstable
  • Clinical evidence of persisting hepatic encephalopathy
  • Pending incarceration
  • Lack of stable housing
  • Active peptic ulcers
  • Unstable diabetes mellitus
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01711125
Other Study ID Numbers  ICMJE X11-0154
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Paul Haber, South West Sydney Local Health District
Study Sponsor  ICMJE South West Sydney Local Health District
Collaborators  ICMJE
  • National Health and Medical Research Council, Australia
  • University of Sydney
Investigators  ICMJE
Principal Investigator: Paul S Haber, MBBS Sydney Local Health District
Principal Investigator: Andrew Baillie, PhD Macquarie University
Principal Investigator: Kirsten C Morley, PhD University of Sydney
PRS Account South West Sydney Local Health District
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP