Exploring the Efficacy and Biobehavioural Basis of Baclofen in the Treatment of Alcoholic Liver Disease
Overview
- Phase
- Phase 3
- Intervention
- Baclofen 75mg/day
- Conditions
- Alcoholic Liver Disease
- Sponsor
- South West Sydney Local Health District
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- alcohol consumption
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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).
Investigators
Professor Paul Haber
Clinica Director
South West Sydney Local Health District
Eligibility Criteria
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
Arms & Interventions
Arm 2
Baclofen high dose
Intervention: Baclofen 75mg/day
Arm 1
Baclofen low dose
Intervention: Baclofen 30mg/day
Arm 3
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
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
Secondary Outcomes
- clinical markers of liver injury(12 weeks)
- incidence of hepatic side effects(12 weeks)
- craving for alcohol(12 weeks)
- early termination due to side effects(12 weeks)