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

Phase 3

Completed

• Conditions: Alcoholic Liver Disease; Alcohol Dependence
• Interventions: Drug: Baclofen 30mg/day; Drug: Baclofen 75mg/day; Drug: Placebo

• Registration Number: NCT01711125
• Lead Sponsor: South West Sydney Local Health District

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).

Study Timeline

• Study First Submitted: 2012-10-16
• Study First Submitted QC: 2012-10-19
• Study First Posted: 2012-10-22
• Study Start: 2013-03
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-07
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Baclofen 30mg/day	Baclofen low dose
Arm 2	Baclofen 75mg/day	Baclofen high dose
Arm 3	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
craving for alcohol	12 weeks
early termination due to side effects	12 weeks
clinical markers of liver injury	12 weeks
incidence of hepatic side effects	12 weeks

Trial Locations

Locations (1)

Drug Health Services, Royal Prince Alfred Hospital; 🇦🇺 Sydney, New South Wales, Australia