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Defining the Clinical Role of Topiramate in the Treatment of Alcohol Dependence in Australia

NCT03479086 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2018-05-11

No results posted yet for this study

Summary

To compare the clinical effectiveness, tolerability, and cost-effectiveness of topiramate to active control (naltrexone) on treatment outcomes for alcohol dependence in a double-blind randomised controlled trial.

Conditions

  • Alcohol Dependence

Interventions

DRUG

Topiramate

200mg/day 100mg b.i.d

DRUG

Naltrexone

50mg/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
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-20
Primary Completion
2020-11-01
Completion
2020-11-01

Countries

  • Australia

Study Locations

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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 NCT03479086 on ClinicalTrials.gov