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

No results posted yet for this study

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

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01711125 on ClinicalTrials.gov