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

Alcohol Dependence Clinical Trial

— BacALD  

Official title:

Exploring the Efficacy and Biobehavioural Basis of Baclofen in the Treatment of Alcoholic Liver Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01711125
• Other study ID #: X11-0154
• Status: Completed
• Phase: Phase 3
• First received: October 16, 2012
• Last updated: August 7, 2017
• Start date: March 2013
• Est. completion date: June 2017

Study information

• Verified date: August 2017
• Source: South West Sydney Local Health District
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholic Liver Disease
• Alcoholism
• Liver Diseases
• Liver Diseases, Alcoholic

Intervention

Drug:
• Baclofen 30mg/day
30mg/day 10 mg t.i.d
• Baclofen 75mg/day
75mg/day 25 mg t.i.d
• Placebo
Placebo 3 matched tabs/day

Locations

Country	Name	City	State
Australia	Drug Health Services, Royal Prince Alfred Hospital	Sydney	New South Wales

Sponsors (3)

Lead Sponsor	Collaborator
South West Sydney Local Health District	National Health and Medical Research Council, Australia, University of Sydney

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	alcohol consumption	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	12 weeks
Secondary	clinical markers of liver injury		12 weeks
Secondary	incidence of hepatic side effects		12 weeks
Secondary	craving for alcohol		12 weeks
Secondary	early termination due to side effects		12 weeks