Status:
UNKNOWN
Defining the Clinical Role of Topiramate in the Treatment of Alcohol Dependence in Australia
Lead Sponsor:
South West Sydney Local Health District
Collaborating Sponsors:
National Health and Medical Research Council, Australia
University of Sydney
Conditions:
Alcohol Dependence
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 contr...
Detailed Description
Clinicians urgently require new treatment strategies for the treatment of alcohol dependence. Although alcohol use disorders are a leading cause of preventable death in Australia, their treatment is g...
Eligibility Criteria
Inclusion
- Alcohol Use Disorder according to the Diagnostic and Statistical Manual of Mental Disorders Version V criteria
- Age 18-70
- Average weekly alcohol consumption of \>30 standard drinks for men and \>25 standard drinks for women, with a weekly average of \> 2 heavy drinking days during the month before screening
- Adequate cognition and English language skills to give valid consent and complete research interviews
- Willingness to give written informed consent
- Willingness to provide a blood sample for genotyping
- Written informed consent
Exclusion
- Active major psychological disorder associated with psychosis, significant suicide risk, and signs of impaired cognitive functioning
- Pregnancy or lactation
- Concurrent use of any psychotropic medication other than antidepressants
- Currently taking any tricyclic antidepressant
- Use of antiretroviral dolutegravir
- Any substance dependence other than nicotine
- Opioid abuse, opioid dependence, or on opioid maintenance treatment
- Clinically significant liver disease
- History of nephrolithiasis
- History of glaucoma
- Lack of stable housing and/or contact phone number
- Previous hypersensitivity to TOP or NTX
- Any alcohol pharmacotherapy within the past month
Key Trial Info
Start Date :
June 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2020
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT03479086
Start Date
June 20 2017
End Date
November 1 2020
Last Update
May 11 2018
Active Locations (1)
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1
Drug Health Services, Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050