Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000423516
Ethics application status
Approved
Date submitted
27/09/2006
Date registered
3/10/2006
Date last updated
3/10/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study of the pharmacokinetics, efficacy, and acceptability of a novel nicotine inhaler in smokers
Scientific title
A pilot study of the pharmacokinetics, affect on Smoking Urges, and acceptability of a novel nicotine inhaler in smokers
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco use disorder 1394 0
Nicotine addiction 1395 0
Condition category
Condition code
Mental Health 1487 1487 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cross over study. Interventions: on the first day one smoked cigarette, on the second day 1 inhalation of 50 micrograms of nicotine inhaler every 30s for 5 minutes, on the third day 1 inhalation of 100 micrograms of nicotine inhaler every 30s for 5 min. This allows for a 24-hour wash-out
Intervention code [1] 1378 0
Treatment: Devices
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 2058 0
Pharmacokinetics of nicotine
Timepoint [1] 2058 0
At time = 0, 1, 5, 10, 15, 30 minutes
Secondary outcome [1] 3547 0
Acceptability, Cigarette Evaluation Scale, Questionnaire of Smoking Urges.
Timepoint [1] 3547 0
Assessed immediately after administration.

Eligibility
Key inclusion criteria
Smoked >10 cigarettes per day.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Recent use of other nicotine replacement therapy such as bupropion; cardiovascular, psychiatric history of note.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1st day= cigarette, 2nd day=50mcg, 3rd day=100mcg
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/10/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 403 0
New Zealand
State/province [1] 403 0

Funding & Sponsors
Funding source category [1] 1624 0
Charities/Societies/Foundations
Name [1] 1624 0
Asthma & Respiratory Foundation of New Zealand
Country [1] 1624 0
New Zealand
Primary sponsor type
Individual
Name
Professor Julian Crane
Address
Country
Secondary sponsor category [1] 1425 0
University
Name [1] 1425 0
Wellington School of Medicine
Address [1] 1425 0
Country [1] 1425 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3071 0
Central Regional Ethics Committee
Ethics committee address [1] 3071 0
Ethics committee country [1] 3071 0
New Zealand
Date submitted for ethics approval [1] 3071 0
Approval date [1] 3071 0
Ethics approval number [1] 3071 0
CEN06/04026

Summary
Brief summary
A pilot study to test the hypothesis that this novel nicotine inhaler will provide a pharmacokinetic profile very similar to that produced by smoking a cigarette and thus will be effective in reducing smoking urges
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27605 0
Address 27605 0
Country 27605 0
Phone 27605 0
Fax 27605 0
Email 27605 0
Contact person for public queries
Name 10567 0
Brent Caldwell
Address 10567 0
Wellington School of Medicine
23A Mein Street
Newtown Wellington
Country 10567 0
New Zealand
Phone 10567 0
+64 4 3855541
Fax 10567 0
Email 10567 0
[email protected]
Contact person for scientific queries
Name 1495 0
Professor Julian Crane
Address 1495 0
Wellington School of Medicine
23A Mein Street
Newtown Wellington
Country 1495 0
New Zealand
Phone 1495 0
+61 4 3855541
Fax 1495 0
Email 1495 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.