Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000373673
Ethics application status
Approved
Date submitted
5/09/2005
Date registered
13/09/2005
Date last updated
24/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A Trial of Pre-Quitting Nicotine Replacement Therapy
Scientific title
A single blind randomised controlled trial comparing the use of Nicotine Replacement Therapy (NRT) while still smoking for 2 weeks prior to quitting followed by usual NRT practice, with usual NRT cessation practice on smoking abstinence at 6 months.
Secondary ID [1] 252016 0
PQNIQ
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 468 0
Condition category
Condition code
Public Health 546 546 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is a single blind randomised controlled trial of Nicotine replacement therapy (HABITROL: patches and/or gum)while still smoking for two weeks prior to Quit Day followed by usual practice, versus usual practice. Usual practice comprises an 8 week programme of NRT patches and or gum and support calls (eg Quitline) or face to face visits for other cessation providers (eg Aukati Kai Paipa), commencing on Quit Day.
Intervention code [1] 352 0
Treatment: Drugs
Comparator / control treatment
Usual practice
Control group
Active

Outcomes
Primary outcome [1] 638 0
Difference in smoking abstinence between the two groups
Timepoint [1] 638 0
Measured 6 months after Quit Day
Secondary outcome [1] 1311 0
1) That the use of NRT in the two weeks prior to quitting followed by standard NRT treatment for eight weeks is more effective than standard NRT treatment alone, on smoking abstinence.
Timepoint [1] 1311 0
Measured at 6 months after Quit Day.
Secondary outcome [2] 1312 0
2) That the intervention is cost-effective
Timepoint [2] 1312 0
Measured at six months after Quit Day.
Secondary outcome [3] 1313 0
3) That the intervention has no more adverse effects than would be expected with usual treatment.
Timepoint [3] 1313 0
Measured at 3 and 6 months after Quit Day.
Secondary outcome [4] 1314 0
4) That the period of familiarisation with NRT is the key factor underpinning effectiveness
Timepoint [4] 1314 0
Measured at 3 and 6 months after Quit Day.

Eligibility
Key inclusion criteria
Participants will be smokers from throughout New Zealand, who are interested in quitting within the next few days or at most within 2 weeks. Participants will be eligible for inclusion in the trial provided that they are eligible for subsidised NRT according to Quitline criteria. These are as follows: at least 18 years of age, have their first cigarette within 30 minutes of waking (a measure of nicotine dependency)have a telephone, and are able to provide consent.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People will be excluded from the trial if they meet any of the criteria used by Quitline and other cessation providers to decline NRT or to seek medical approval. These are as follows:are pregnant or breastfeedingare current users of NRT productsuse non-cigarette tobacco products (e.g. snuff, pipes, cigars)Is not currently using Zyban (Buproprion) or Nortriptylinehave had a stroke or heart related condition in the last 3 months.

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)
Central randomisation by IT person
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Computer-generated - stratified minimisation. Three stratification factors are used: age, sex, level of nicotine dependence.
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1100
Accrual to date
Final
Recruitment outside Australia
Country [1] 163 0
New Zealand
State/province [1] 163 0

Funding & Sponsors
Funding source category [1] 603 0
Government body
Name [1] 603 0
Health Research Council
Country [1] 603 0
New Zealand
Funding source category [2] 604 0
Charities/Societies/Foundations
Name [2] 604 0
National Heart Foundation
Country [2] 604 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council (NZ)
Address
Level 3, 110 Stanley Street, Auckland, 1010, New Zealand
Country
New Zealand
Secondary sponsor category [1] 492 0
University
Name [1] 492 0
Clinical Trials Reseach Unit
Address [1] 492 0
Level 4, School of Population Health, Tamaki Campus, University of Auckland, Glen Innes, Auckland, 1072
Country [1] 492 0
New Zealand

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Pre-cessation nicotine replacement therapy: pragmatic randomized trial. Bullen C, Howe C, Lin RB, Grigg M, Laugesen M, McRobbie H, Glover M, Walker N, Wallace-Bell M, Whittaker R, Rodgers A. Addiction 2010;
Public notes

Contacts
Principal investigator
Name 35796 0
Address 35796 0
Country 35796 0
Phone 35796 0
Fax 35796 0
Email 35796 0
Contact person for public queries
Name 9541 0
Dr Chris Bullen
Address 9541 0
Clinical Trials Research Unit
University of Auckland
Private Bag 92019
Auckland
Country 9541 0
New Zealand
Phone 9541 0
+64 9 3737999
Fax 9541 0
+64 9 3731710
Email 9541 0
[email protected]
Contact person for scientific queries
Name 469 0
Dr Chris Bullen
Address 469 0
Clinical Trials Research Unit
University of Auckland
Private Bag 92019
Auckland
Country 469 0
New Zealand
Phone 469 0
+64 9 3737999
Fax 469 0
+64 9 3731710
Email 469 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
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