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

South West Sydney Local Health District

Status and phase: Completed; Phase 3

Conditions: Alcoholic Liver Disease; Alcohol Dependence

Treatments: Drug: Baclofen 30mg/day; Drug: Placebo; Drug: Baclofen 75mg/day

Study type: Interventional

Funder types: Other

Identifiers

NCT01711125

X11-0154

Details and patient eligibility

About

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.

Full 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).

Enrollment: 104 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 3 patient groups, including a placebo group

Arm 1

Experimental group

Description:

Baclofen low dose

Treatment:

Drug: Baclofen 30mg/day

Arm 2

Experimental group

Description:

Baclofen high dose

Treatment:

Drug: Baclofen 75mg/day

Arm 3

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo