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

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: South West Sydney Local Health District
• Collaborators: National Health and Medical Research Council, Australia; University of Sydney
• Treatments: Baclofen

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