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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03479086
Registration number
NCT03479086
Ethics application status
Date submitted
5/03/2018
Date registered
27/03/2018
Date last updated
11/05/2018
Titles & IDs
Public title
Defining the Clinical Role of Topiramate in the Treatment of Alcohol Dependence in Australia
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Scientific title
Defining the Clinical Role of Topiramate in the Treatment of Alcohol Dependence in Australia
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Secondary ID [1]
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X16-0231
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alcohol Dependence
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Condition category
Condition code
Mental Health
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Addiction
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Topiramate
Treatment: Drugs - Naltrexone
Experimental: Topiramate - Topiramate 200mg/day
Experimental: Naltrexone - Naltrexone 50mg/day
Treatment: Drugs: Topiramate
200mg/day 100mg b.i.d
Treatment: Drugs: Naltrexone
50mg/day
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of heavy drinking days, as measured by the Time Line Follow Back
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Assessment method [1]
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Corroborated with Phosphatidylethanol (PEth) levels
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Timepoint [1]
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Over 12 weeks
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Primary outcome [2]
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Time to relapse, as measured by the Time Line Follow Back
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Assessment method [2]
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Corroborated with PEth levels
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Timepoint [2]
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Over 12 weeks
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Primary outcome [3]
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Time to lapse, as measured by the Time Line Follow Back
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Assessment method [3]
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Corroborated with PEth levels
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Timepoint [3]
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Over 12 weeks
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Primary outcome [4]
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Number of days abstinent, as measured by the Time Line Follow Back
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Assessment method [4]
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Corroborated with PEth levels
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Timepoint [4]
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Over 12 weeks
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Primary outcome [5]
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Number of standard drinks per drinking day, as measured by the Time Line Follow Back
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Assessment method [5]
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Corroborated with PEth levels
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Timepoint [5]
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12 weeks
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Secondary outcome [1]
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Self report of adverse events
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Assessment method [1]
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as reported by patient during weekly medical management sessions facilitated by the treating doctor.
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Timepoint [1]
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12 weeks
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Secondary outcome [2]
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Penn Alcohol Craving Scale for alcohol craving
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Assessment method [2]
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as measured by amount of time spent thinking and craving for alcohol, difficulty in resisting consumption of alcohol if present and hypothetical pleasure associated with consumption of alcohol.
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Timepoint [2]
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12 weeks
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Secondary outcome [3]
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DASS21 score for presence and/or severity of anxiety
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Assessment method [3]
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as measured by cumulative score of anxiety related questions on the Depression, Anxiety Stress Scale-21 (DASS21).
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Timepoint [3]
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12 weeks
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Secondary outcome [4]
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DASS21 score for presence and/or severity of depression
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Assessment method [4]
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as measured by cumulative score for depression related questions
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Timepoint [4]
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12 weeks
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Secondary outcome [5]
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Insomnia Severity Index for sleep disturbances
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Assessment method [5]
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as measured by cumulative score of satisfaction with current sleep patterns and extent to which sleep disturbances interfere and impair with every day activities and daily functioning
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Timepoint [5]
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12 weeks
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Secondary outcome [6]
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Blood glucose test for diabetes
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Assessment method [6]
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as measured by fasting blood glucose levels in blood
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Timepoint [6]
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12 weeks
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Secondary outcome [7]
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Liver function tests for clinical markers of liver injury
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Assessment method [7]
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as measured by levels of liver enzymes, Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST) in blood
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Timepoint [7]
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12 weeks
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Secondary outcome [8]
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Body Mass Index
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Assessment method [8]
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as measured by weight in kilograms (kg) and height in metres (m). These two measurements will be combined together to report BMI in kg/m^2.
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Timepoint [8]
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12 weeks
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Secondary outcome [9]
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Number of cigarettes smoked daily, as measured by Time Line Follow Back
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Assessment method [9]
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Timepoint [9]
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12 weeks
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Secondary outcome [10]
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Self report of daily measures of expectancies, confidence and drinking
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Assessment method [10]
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as measured using a scale of the likelihood of having a good time and feeling more relaxed if alcohol was consumed.
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Timepoint [10]
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12 weeks
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/06/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/11/2020
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Actual
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Sample size
Target
180
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Drug Health Services, Royal Prince Alfred Hospital - Sydney
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Recruitment postcode(s) [1]
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2050 - Sydney
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Funding & Sponsors
Primary sponsor type
Other
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Name
South West Sydney Local Health District
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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National Health and Medical Research Council, Australia
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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University of Sydney
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
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 controlled trial.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03479086
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Paul S Haber, MBBS
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Address
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Sydney Local Health District
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Kirsten Morley, PhD
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Address
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Country
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Phone
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95153636
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03479086
Download to PDF