Clinical Trial: Baclofen in the Treatment of Alcoholic Liver Disease

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: 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 alcoholic cirrhosis in a double-blind randomised placebo-controlled trial.

Detailed Summary:

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).


Sponsor: South West Sydney Local Health District

Current Primary Outcome: 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: alcohol consumption [ Time Frame: 12 weeks ]

as measured by the number of days abstinent, time to relapse, and number of drinks per drinking day


Current Secondary Outcome:

  • 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: Same as current

Information By: South West Sydney Local Health District

Dates:
Date Received: October 16, 2012
Date Started: March 2013
Date Completion: December 2015
Last Updated: September 28, 2014
Last Verified: September 2014