Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000511235
Ethics application status
Approved
Date submitted
22/06/2009
Date registered
29/06/2009
Date last updated
29/06/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Does nicotine improve selective attention more than placebo in healthy volunteers and what does this tell us about mechanisms of attention?
Scientific title
Does nicotine improve selective attention more than placebo in healthy volunteers?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Selective attention 237074 0
Condition category
Condition code
Neurological 237394 237394 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single application of nicotine patch (7mg) for 2 hours
Please note: minimum washout period between conditions is 1 week
Intervention code [1] 236793 0
Other interventions
Comparator / control treatment
Single application of identical looking placebo patch for 2 hours

Please note: minimum washout period between conditions is 1 week
Control group
Placebo

Outcomes
Primary outcome [1] 238194 0
Measures of selective attention:
1. Eriksen Flanker Task
2. Covert Visual Orienting Task
Timepoint [1] 238194 0
1 hour following application of patch
Secondary outcome [1] 242500 0
Nil
Timepoint [1] 242500 0
Nil

Eligibility
Key inclusion criteria
Healthy volunteers
History of non-dependent nicotine exposure (e.g. casual smoker)
Minimum age
18 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current smokers
History of nicotine dependence
Current or history of major psychiatric or neurological illness
Current or history of substance dependence

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation schedule generated by external research site.
Researchers and participants will be blinded to treatment allocation.
Each new subject will be given the next available subject number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised schedule was generated by an external trials research site.
Sequence generated using a random number generator. No blocking procedures were used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237190 0
University
Name [1] 237190 0
Queensland Brain Institute (QBI)
Country [1] 237190 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Mark Bellgrove
Address
Queensland Brain Institute
QBI Building (79)
Upland Road
The University of Queensland
St Lucia, 4072 QLD
Country
Australia
Secondary sponsor category [1] 4683 0
None
Name [1] 4683 0
Address [1] 4683 0
Country [1] 4683 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239283 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 239283 0
Ethics committee country [1] 239283 0
Australia
Date submitted for ethics approval [1] 239283 0
Approval date [1] 239283 0
18/06/2009
Ethics approval number [1] 239283 0
2009000818

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29781 0
Address 29781 0
Country 29781 0
Phone 29781 0
Fax 29781 0
Email 29781 0
Contact person for public queries
Name 13028 0
Associate Professor Mark Bellgrove
Address 13028 0
QBI Building (79)
Upland Road
The University of Queensland
St Lucia, 4072 QLD
Country 13028 0
Australia
Phone 13028 0
61 7 3346 6329
Fax 13028 0
Email 13028 0
m.bellgrove@uq.edu.au
Contact person for scientific queries
Name 3956 0
Associate Professor Mark Bellgrove
Address 3956 0
QBI Building (79)
Upland Road
The University of Queensland
St Lucia, 4072 QLD
Country 3956 0
Australia
Phone 3956 0
61 7 3346 6329
Fax 3956 0
Email 3956 0
m.bellgrove@uq.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.