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

Sponsor

South West Sydney Local Health District (Other)

Overall Status

Completed

CT.gov ID

NCT01711125

Collaborator

National Health and Medical Research Council, Australia (Other), University of Sydney (Other)

104

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcoholic Liver Disease Alcohol Dependence	Drug: Baclofen 30mg/day Drug: Baclofen 75mg/day Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Baclofen low dose	Drug: Baclofen 30mg/day 30mg/day 10 mg t.i.d
Experimental: Arm 2 Baclofen high dose	Drug: Baclofen 75mg/day 75mg/day 25 mg t.i.d
Placebo Comparator: Arm 3 Placebo	Drug: Placebo Placebo 3 matched tabs/day

Arm

Intervention/Treatment

Experimental: Arm 1

Baclofen low dose

Drug: Baclofen 30mg/day

30mg/day 10 mg t.i.d

Experimental: Arm 2

Baclofen high dose

Drug: Baclofen 75mg/day

75mg/day 25 mg t.i.d

Placebo Comparator: Arm 3

Placebo

Drug: Placebo

Placebo 3 matched tabs/day

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Drug Health Services, Royal Prince Alfred Hospital	Sydney	New South Wales	Australia	2050

Sponsors and Collaborators

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

Investigators

Principal Investigator: Paul S Haber, MBBS, Sydney Local Health District
Principal Investigator: Andrew Baillie, PhD, Macquarie University
Principal Investigator: Kirsten C Morley, PhD, University of Sydney

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Professor Paul Haber, Clinica Director, South West Sydney Local Health District

ClinicalTrials.gov Identifier:

NCT01711125

Other Study ID Numbers:

X11-0154

First Posted:

Oct 22, 2012

Last Update Posted:

Aug 8, 2017

Last Verified:

Aug 1, 2017

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Liver Diseases

Liver Diseases, Alcoholic

Alcoholism

Baclofen

Study Results

No Results Posted as of Aug 8, 2017