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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03479086




Registration number
NCT03479086
Ethics application status
Date submitted
5/03/2018
Date registered
27/03/2018

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
Timepoint [1] 0 0
Over 12 weeks
Primary outcome [2] 0 0
Time to relapse, as measured by the Time Line Follow Back
Timepoint [2] 0 0
Over 12 weeks
Primary outcome [3] 0 0
Time to lapse, as measured by the Time Line Follow Back
Timepoint [3] 0 0
Over 12 weeks
Primary outcome [4] 0 0
Number of days abstinent, as measured by the Time Line Follow Back
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
Timepoint [5] 0 0
12 weeks
Secondary outcome [1] 0 0
Self report of adverse events
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Penn Alcohol Craving Scale for alcohol craving
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
DASS21 score for presence and/or severity of anxiety
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
DASS21 score for presence and/or severity of depression
Timepoint [4] 0 0
12 weeks
Secondary outcome [5] 0 0
Insomnia Severity Index for sleep disturbances
Timepoint [5] 0 0
12 weeks
Secondary outcome [6] 0 0
Blood glucose test for diabetes
Timepoint [6] 0 0
12 weeks
Secondary outcome [7] 0 0
Liver function tests for clinical markers of liver injury
Timepoint [7] 0 0
12 weeks
Secondary outcome [8] 0 0
Body Mass Index
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
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
Sex
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
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2020
Actual
Sample size
Target
180
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03479086