Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000882921
Ethics application status
Approved
Date submitted
17/08/2011
Date registered
18/08/2011
Date last updated
18/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Could alcohol improve simultaneous touch sensation?
Scientific title
Could alcohol improve tactile acuity in a healthy 18 - 40 year olds?
Secondary ID [1] 262528 0
Nil.
Universal Trial Number (UTN)
U1111-1122-3981
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy volunteers will be studied to determine the effect of alcohol on tactile acuity. 268197 0
Condition category
Condition code
Neurological 268324 268324 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Alcohol will be administered to the intervention group orally via consumption of high strength spirits (e.g. 30ml nip of vodka, 40% alc. Volume) in one session only. Alcohol dosage will be administered according to the gender, age and weight of the participant over a 30 minute period with the intention of attaining a blood alcohol content of 0.08 – 0.12. Two-point discrimination will be assessed by trained physiotherapists using a commercially available tool.
Intervention code [1] 266874 0
Treatment: Drugs
Comparator / control treatment
Patients will consume non-alcoholic beverages. Two-point discrimination will be assessed by trained physiotherapists using a commercially available tool.
Control group
Placebo

Outcomes
Primary outcome [1] 269095 0
Tactile acuity measured with two-point discrimination (measurement given in milimeters).
Timepoint [1] 269095 0
Tactile acuity will measured in each of the six body regions immediately prior to the intervention. The intervention group and control group will have 30 mins to consume their allocated beverages. Tactile acuity will be assessed immediately after the intervention period.
Secondary outcome [1] 276921 0
Nil
Timepoint [1] 276921 0
Nil

Eligibility
Key inclusion criteria
Pain free healthy participants with: no existing morbidities (eg diabetes, peripheral vascular disease); normal sensation throughout testing sites to light touch, blunt/pin prick.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No known or suspected pregnancy

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)
Advertisement via flyers on University campus. Interested participants will respond to flyers via email or telephone. Allocation will be concealed via sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2011
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)
Recruitment postcode(s) [1] 4360 0
5000

Funding & Sponsors
Funding source category [1] 267346 0
University
Name [1] 267346 0
University of South Australia
Country [1] 267346 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
City East campus
North Terrace, Adelaide
South Australia 5000
Australia
Country
Australia
Secondary sponsor category [1] 266412 0
None
Name [1] 266412 0
Address [1] 266412 0
Country [1] 266412 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271625 0
UniSA Human Research Ethics Committee
Ethics committee address [1] 271625 0
Ethics committee country [1] 271625 0
Australia
Date submitted for ethics approval [1] 271625 0
11/07/2011
Approval date [1] 271625 0
16/08/2011
Ethics approval number [1] 271625 0
Protocol number: 24700

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

Contacts
Principal investigator
Name 32811 0
Address 32811 0
Country 32811 0
Phone 32811 0
Fax 32811 0
Email 32811 0
Contact person for public queries
Name 16058 0
Mark Catley
Address 16058 0
Body In Mind Research Group
Level 7 Centenary Building
University of South Australia
City East campus
North Terrace, Adelaide
South Australia 5000
Australia
Country 16058 0
Australia
Phone 16058 0
+61 8 8302 2071
Fax 16058 0
Email 16058 0
[email protected]
Contact person for scientific queries
Name 6986 0
Abby Tabor
Address 6986 0
Body In Mind Research Group
Level 7 Centenary Building
University of South Australia
City East campus
North Terrace, Adelaide
South Australia 5000
Australia
Country 6986 0
Australia
Phone 6986 0
+61 8 8302 2071
Fax 6986 0
Email 6986 0
[email protected]

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.