Baclofen in the Treatment of Alcohol Dependence With or Without Alcoholic Liver Disease
NCT01711125 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104
Last updated 2017-08-08
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.
Conditions
- Alcoholic Liver Disease
- Alcohol Dependence
Interventions
- DRUG
-
Baclofen 30mg/day
30mg/day 10 mg t.i.d
- DRUG
-
Baclofen 75mg/day
75mg/day 25 mg t.i.d
- DRUG
-
Placebo 3 matched tabs/day
Sponsors & Collaborators
-
National Health and Medical Research Council, Australia
collaborator OTHER -
University of Sydney
collaborator OTHER -
South West Sydney Local Health District
lead OTHER
Principal Investigators
-
Paul S Haber, MBBS · Sydney Local Health District
-
Andrew Baillie, PhD · Macquarie University
-
Kirsten C Morley, PhD · University of Sydney
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-03-31
- Primary Completion
- 2017-06-30
- Completion
- 2017-06-30
Countries
- Australia
Study Locations
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