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

• Status: Unknown status
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: South West Sydney Local Health District
• Collaborators: National Health and Medical Research Council, Australia; University of Sydney
• Treatments: Naltrexone; Topiramate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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