Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000587404
Ethics application status
Approved
Date submitted
12/11/2007
Date registered
16/11/2007
Date last updated
16/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of pharmokinetics. tobacco withdrawal relief and acceptability of an electronic inhaled nicotine delivery device (Ruyan e-cigarette).
Scientific title
Evaluation of pharmokinetics. tobacco withdrawal relief and acceptability of an electronic inhaled nicotine delivery device (Ruyan e-cigarette).
Secondary ID [1] 288549 0
Nil known
Universal Trial Number (UTN)
Trial acronym
WIRED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 2532 0
Condition category
Condition code
Public Health 2632 2632 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ruyan e-cigarette (16mg nicotine)- inhaled nicotine, taken as required for 8 hours.
Nicorette® inhaler - inhaled, but buccal absorption. Regular sessions of puffing for 20 minutes as required over 8 hours.
Washout period between treatments is 3 days, when participants will be able to smoke as normal.
Intervention code [1] 2265 0
Lifestyle
Comparator / control treatment
Ruyan e-cigarette (0mg nicotine) placebo (primary comparator).
Nicorette® nicotine inhaler
Normal factory made cigarettes
Control group
Placebo

Outcomes
Primary outcome [1] 3546 0
Change in nicotine cravings and withdrawal ratings when using the different treatment conditions.
Timepoint [1] 3546 0
For 5, 10, 15, 20, 25, 30, 40, 50 and 60 minutes after first receiving the treatment.
Also 8 hours later, after being able to use the intervention during the day.
Secondary outcome [1] 5930 0
Assessment of side effects of the medication using a questionnaire.
Timepoint [1] 5930 0
For 5 to 60 minutes after first receiving the treatment.
Also 8 hours later, after being able to use the intervention during the day.
Secondary outcome [2] 5931 0
Blood plasma nicotine levels in 12 of the 48 participants.
Timepoint [2] 5931 0
2, 5, 10, 15, 30 and 60 minutes after first receiving the treatment.
Secondary outcome [3] 5935 0
Assessment of satisfaction and helpfulness of the product using a questionnaire.
Timepoint [3] 5935 0
For 5 to 60 minutes after first receiving the treatment.
Also 8 hours later, after being able to use the intervention during the day.
Secondary outcome [4] 5936 0
Rating of the cigarette smoked using a questionnaire.
Timepoint [4] 5936 0
At the end of the day, approximately 8 hours after first receiving the treatment.

Eligibility
Key inclusion criteria
Have smoked 15 cigarettes or more a day for the last year,
Smoke within 30 minutes of waking,
Self-report being in good health with verification by a brief screening examination,
Able to attend the study site for the duration of the study,
Able to read and write English,
Capable of giving informed consent,
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Recent (within 6 months) myocardial infarction, angina pectoris, or other serious medical condition.
Severe allergic condition.
Poorly controlled asthma or other airways disease.
Diabetes mellitus.
Current chemical dependence other than nicotine.
Poorly controlled psychiatric disorder.
Pregnant (will have negative urinary dipstick for ßHCG).
Breast feeding.
Blood pressure greater than 180 mmHg systolic and/or 100 mmHg diastolic.
Current use of other smoking cessation medications of any sort.
Participants who are unwilling to abstain from smoking from 8pm the day before each study day until the end of study day (CO verified).
Participants who wish to stop smoking during the study period. Participants who smoke only hand rolled cigarettes.
Note: participants who wish to cease smoking after the study will be offered assistance (pharmacological treatment and behavioral support).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The trial will be advertised and respondents will have the trial explained to them. If they are interested will be asked to sign a consent form and under go screening. Participants will be randomised to a predetermined sequences of drug administration over the study period of the active trial with a 3-day period of normal smoking between the administrations of each individual drug in the sequence.
A randomisation code will be affixed to the plastic bag containing each product. Four different products will be packaged together into a single box (study product pack), which will be assigned a pack number. On the first study day a study product pack will be given to participants, sequentially, on arrival. The pack number will be recorded next to the participant number and also on the study product supply form which will tell the researcher which individual product to give on each study day. This sheet will only list the randomisation code, not the product name.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation codes will be prepared by computer in advance, four for each participant. On arrival to each study session study staff will retrieve the product corresponding to the relevant randomisation code.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Only 12 of the 48 participants will have blood samples taken to determine nicotine serum levels.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/01/2008
Actual
15/01/2008
Date of last participant enrolment
Anticipated
Actual
20/02/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 648 0
New Zealand
State/province [1] 648 0
Auckland

Funding & Sponsors
Funding source category [1] 2778 0
Commercial sector/Industry
Name [1] 2778 0
Health New Zealand Ltd
Country [1] 2778 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
SBT Holdings Ltd
Address
Rm 1010,
West Tower Shun Tak Centre,
168 Connaught Road Central
Country
Hong Kong
Secondary sponsor category [1] 2510 0
University
Name [1] 2510 0
National Institute for Health Innovation (NIHI)
Address [1] 2510 0
University of Auckland,
School of Population Health
Tamaki Campus
Glen Innes
Auckland
Country [1] 2510 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4697 0
Northern Y Ethics Committee
Ethics committee address [1] 4697 0
3rd floor, BNZ building
354 Victoria St
PO Box 1031
Hamilton
Ethics committee country [1] 4697 0
New Zealand
Date submitted for ethics approval [1] 4697 0
24/10/2007
Approval date [1] 4697 0
09/01/2008
Ethics approval number [1] 4697 0

Summary
Brief summary
This study tests the hypothesis that a more rapid nicotine delivery from nicotine replacement therapy results in a superior withdrawal relief, and improved product satisfaction.
It compares the Ruyan e-cigarette inhaled nicotine delivery device to existing nicotine therapy and placebo, in conferring withdrawal relief in 48 people. Time to peak serum nicotine levels will be compared between the products in 12 of the 48 people. Time to peak concentration will be correlated with reported withdrawal symptoms.
Trial website
No external website.
Trial related presentations / publications
C Bullen, H McRobbie, S Thornley, et al. Effect of an electronic nicotine delivery device (e cigarette) on desire to smoke and withdrawal, user preferences and nicotine delivery: randomised cross-over trial. Tob Control 2010 19: 98-103
Public notes

Contacts
Principal investigator
Name 28168 0
Prof Hayden Mcrobbie
Address 28168 0
NIHI,, University of Auckland School of Population Health Tamaki Campus Glen Innes Auckland
Country 28168 0
New Zealand
Phone 28168 0
+6493733599
Fax 28168 0
Email 28168 0
[email protected]
Contact person for public queries
Name 11325 0
Prof Chris Bullen
Address 11325 0
Clinical Trials Research Unit
University of Auckland
School of Population Health
Tamaki Campus
Glen Innes
Auckland
Country 11325 0
New Zealand
Phone 11325 0
(+64) 9 3737599 extn: 84726
Fax 11325 0
Email 11325 0
[email protected]
Contact person for scientific queries
Name 2253 0
Prof Chris Bullen
Address 2253 0
NIHI, University of Auckland School of Population Health Tamaki Campus Glen Innes Auckland
Country 2253 0
New Zealand
Phone 2253 0
+64 9 3737599 extn 84730
Fax 2253 0
Email 2253 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.