Alcohol Dependence, Alcoholic Liver Disease
Conditions
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).
Interventions
DRUGBaclofen 30mg/day
30mg/day 10 mg t.i.d
DRUGBaclofen 75mg/day
75mg/day 25 mg t.i.d
DRUGPlacebo
Placebo 3 matched tabs/day
Sponsors
National Health and Medical Research Council, Australia
University of Sydney
South West Sydney Local Health District
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| alcohol consumption | 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Australia
Outcome results
None listed