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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Scientific title
Defining the Clinical Role of Topiramate in the Treatment of Alcohol Dependence in Australia
Secondary ID [1] 0 0
X16-0231
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol Dependence 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Addiction

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of heavy drinking days, as measured by the Time Line Follow Back - Corroborated with Phosphatidylethanol (PEth) levels
Timepoint [1] 0 0
Over 12 weeks
Primary outcome [2] 0 0
Time to relapse, as measured by the Time Line Follow Back - Corroborated with PEth levels
Timepoint [2] 0 0
Over 12 weeks
Primary outcome [3] 0 0
Time to lapse, as measured by the Time Line Follow Back - Corroborated with PEth levels
Timepoint [3] 0 0
Over 12 weeks
Primary outcome [4] 0 0
Number of days abstinent, as measured by the Time Line Follow Back - Corroborated with PEth levels
Timepoint [4] 0 0
Over 12 weeks
Primary outcome [5] 0 0
Number of standard drinks per drinking day, as measured by the Time Line Follow Back - Corroborated with PEth levels
Timepoint [5] 0 0
12 weeks
Secondary outcome [1] 0 0
Self report of adverse events - as reported by patient during weekly medical management sessions facilitated by the treating doctor.
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Penn Alcohol Craving Scale for alcohol craving - 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.
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
DASS21 score for presence and/or severity of anxiety - as measured by cumulative score of anxiety related questions on the Depression, Anxiety Stress Scale-21 (DASS21).
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
DASS21 score for presence and/or severity of depression - as measured by cumulative score for depression related questions
Timepoint [4] 0 0
12 weeks
Secondary outcome [5] 0 0
Insomnia Severity Index for sleep disturbances - 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
Timepoint [5] 0 0
12 weeks
Secondary outcome [6] 0 0
Blood glucose test for diabetes - as measured by fasting blood glucose levels in blood
Timepoint [6] 0 0
12 weeks
Secondary outcome [7] 0 0
Liver function tests for clinical markers of liver injury - as measured by levels of liver enzymes, Alanine Transaminase (ALT), Alkaline Phosphatase (ALP) and Aspartate Transaminase (AST) in blood
Timepoint [7] 0 0
12 weeks
Secondary outcome [8] 0 0
Body Mass Index - 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.
Timepoint [8] 0 0
12 weeks
Secondary outcome [9] 0 0
Number of cigarettes smoked daily, as measured by Time Line Follow Back
Timepoint [9] 0 0
12 weeks
Secondary outcome [10] 0 0
Self report of daily measures of expectancies, confidence and drinking - as measured using a scale of the likelihood of having a good time and feeling more relaxed if alcohol was consumed.
Timepoint [10] 0 0
12 weeks

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
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Drug Health Services, Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2050 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
South West Sydney Local Health District
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Sydney
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03479086
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul S Haber, MBBS
Address 0 0
Sydney Local Health District
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kirsten Morley, PhD
Address 0 0
Country 0 0
Phone 0 0
95153636
Fax 0 0
Email 0 0
kirsten.morley@sydney.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03479086