Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000522617
Ethics application status
Approved
Date submitted
1/04/2014
Date registered
16/05/2014
Date last updated
16/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of three e-cigarette nicotine blends,
when used by current smokers.
Scientific title
A Four-Way Crossover Study Comparing Nicotine Pharmacokinetics and Exhaled Carbon Monoxide Levels of a Traditional Tobacco Cigarette and Three Nicotine-Based eLiquid Blends Delivered via e-Cigarette, Following Single Use in Healthy Male Smokers.
Secondary ID [1] 284373 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 291541 0
Condition category
Condition code
Other 291917 291917 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study compares three commercially available eliquid blends with a standard cigarette.

For each of the 3 blends, nicotine concentration is the same, 2%(w/w), 34uL = 0.8 mg nicotine. Typical e-liquid use is 17-51 uL over 10 inhalations (20 - 60 mg delta weight observed when weighing the e-cig before and after use). This represents between 0.4 - 1.2 mg nicotine per series of 10 inhalations.

In particular, researchers want to know:
How much nicotine gets into the blood with each product?
How quickly does nicotine reach maximum levels in the blood with each product?
How much does breath CO increase after using each product?

Each participant will smoke one standard tobacco cigarette and 3 e-cigarettes in a randomised order 90 minutes apart
Intervention code [1] 289104 0
Treatment: Other
Comparator / control treatment
one standard tobacco cigarette containing approximately 20.5mg of nicotine
Control group
Dose comparison

Outcomes
Primary outcome [1] 291827 0
This will give the company important information about nicotine levels of the three eblends compared to traditional cigarettes, which will help further product development.
The concentration of nicotine entering the blood will be measured for each product using multiple blood samples over time.
Timepoint [1] 291827 0
Blood samples will be taken before inhaling and at 10 timepoints from 0 to 30 minutes
Primary outcome [2] 291976 0
The amount of carbon monoxide (CO) in exhaled air will be measured for each product using a validated CO measuring device
Timepoint [2] 291976 0
CO measurement will be taken 1 minute prior to inhalation and at 30 minutes after inhalation commenced.
Secondary outcome [1] 307627 0
none
Timepoint [1] 307627 0
none

Eligibility
Key inclusion criteria
Smoke at least 5 cigarettes per day.
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Impaired lung function

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)
Participants will be allocated a treatment sequence in an allocation concealment manner with allocation determined by "off-site" personnel
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis
The number of participants in this exploratory crossover over study was determined by the logistics. Minimal data is available on the pharmacokinetics of nicotine from e-cigarettes
Analysis of variance will be applied to the log transformed primary pk parameters

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/05/2014
Actual
Date of last participant enrolment
Anticipated
30/06/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 5952 0
New Zealand
State/province [1] 5952 0

Funding & Sponsors
Funding source category [1] 289015 0
Commercial sector/Industry
Name [1] 289015 0
Ploom
Country [1] 289015 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Ploom
Address
660 Alabama Street, Second Floor, San Francisco, CA 94110 , USA
Country
United States of America
Secondary sponsor category [1] 287692 0
None
Name [1] 287692 0
Address [1] 287692 0
Country [1] 287692 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290822 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 290822 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 290822 0
New Zealand
Date submitted for ethics approval [1] 290822 0
20/03/2014
Approval date [1] 290822 0
07/04/2014
Ethics approval number [1] 290822 0

Summary
Brief summary
Measuring nicotine levels in blood following smoking tobacco and e-cigarettes
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47430 0
Dr Chris Wynne
Address 47430 0
Christchurch Clinical Studies Trust Ltd
31 Tuam Street
Christchurch 8011
Country 47430 0
New Zealand
Phone 47430 0
+64 3 372 9477
Fax 47430 0
+64 3 372 9478
Email 47430 0
[email protected]
Contact person for public queries
Name 47431 0
Dr Chris Wynne
Address 47431 0
Christchurch Clinical Studies Trust Ltd
31 Tuam Street
Christchurch 8011
Country 47431 0
New Zealand
Phone 47431 0
+64 3 372 9477
Fax 47431 0
+64 3 372 9478
Email 47431 0
[email protected]
Contact person for scientific queries
Name 47432 0
Dr Chris Wynne
Address 47432 0
Christchurch Clinical Studies Trust Ltd
31 Tuam Street
Christchurch 8011
Country 47432 0
New Zealand
Phone 47432 0
+64 3 372 9477
Fax 47432 0
+64 3 372 9478
Email 47432 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.