Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000451505
Ethics application status
Approved
Date submitted
19/10/2006
Date registered
19/10/2006
Date last updated
8/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Selection of Nicotine Therapy to Increase Quitting
Scientific title
A single-blind randomised controlled trial to determine whether smokers who have more choice over which Nicotine Replacement Therapy (NRT) delivery methods they use are more likely to have quit smoking at six months, than smokers with current practice (with NRT available only by patch and/or gum).
Secondary ID [1] 273470 0
HRC
Universal Trial Number (UTN)
Trial acronym
SONIQ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking (healthy participants who smoke) 1424 0
Condition category
Condition code
Mental Health 1521 1521 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to a selection box of NRT or current practice. Telephone counselling and advice will be available to all participants in the usual manner, via Quitline.

Selection box group: Participants will be sent a box containing four different NRT delivery methods, namely patch (21mg), gum (4mg, fruit and mint), inhaler (10mg), and sublingual tablet (2mg), along with a culturally appropriate video/DVD and printed material. Participants will be asked to try out each product over a week prior to their quit attempt. Participants will then be contacted by telephone and asked to choose one or two preferred methods of delivery to use for eight weeks after their Quit day.
Intervention code [1] 1410 0
Treatment: Other
Comparator / control treatment
Control group: Participants in the current practice group will be supported by Quitline in the usual way for an eight week period, with NRT provided as required in the form of patches (7mg, 14mg or 21mg) and/or gum (2mg or 4mg, mint or fruit).
Control group
Active

Outcomes
Primary outcome [1] 2100 0
The proportion of participants who report 7-day point prevalence abstinence
Timepoint [1] 2100 0
At six months after Quit day (biochemically verified)
Secondary outcome [1] 3634 0
7-day point prevalence abstinence rates
Timepoint [1] 3634 0
One week (treatment group only), three weeks and three month.
Secondary outcome [2] 3635 0
Three week, three month, and six month continuous abstinence rates (Russell Standard). Biochemically verified at six months.
Timepoint [2] 3635 0
Three week, three month, and six month after Quit day. Biochemically verified at 6 months
Secondary outcome [3] 3636 0
Proportion of participants who have significantly reduced (at least 25% reduction) daily smoking levels.
Timepoint [3] 3636 0
Six months after Quit day.
Secondary outcome [4] 3637 0
Current smoking details, if still smoking (including daily consumption level) at one week after selection box use (treatment group only) plus.
Timepoint [4] 3637 0
At three weeks, three months, and six months after Quit day.
Secondary outcome [5] 3638 0
Self-rated chances of quitting (treatment group only, after one weeks use of selection box)
Timepoint [5] 3638 0
One week after Quit day.
Secondary outcome [6] 3639 0
Cost information: Cost outcomes will include cost per quitter, cost per person reducing their daily cigarette consumption, and cost per Quality Adjusted Life Year (QALY) of life saved among quitters. The tobacco expenditure savings to individual smokers will also be calculated using data on the daily amount smoked prior to quitting and the price of the particular products smoked.
Timepoint [6] 3639 0
Six months after Quit day.
Secondary outcome [7] 3640 0
Information on NRT delivery three weeks after Quit day: How participants rate the ease of obtaining the NRT (i.e. Delivery to door of NRT for treatment group versus delivery to door of Quit Card and visit to pharmacy for control group).
Timepoint [7] 3640 0
Three weeks after Quit day
Secondary outcome [8] 3641 0
Information on choice of NRT (treatment group only after one week of use of the selection box): NRT selection (type, dose, flavour), reasons for selection; concerns regarding the use of the products; adequacy of knowledge regarding the use of the products, the importance of having a choice over which products to use, and the importance of the postal delivery of the selection box.
Timepoint [8] 3641 0
One week after Quit day
Secondary outcome [9] 3642 0
NRT use (type, dose, flavour, frequency).
Timepoint [9] 3642 0
At three weeks, three months and six months after Quit day.
Secondary outcome [10] 3643 0
Serious adverse events after one weeks use of NRT in the selection box (treatment group only).
Timepoint [10] 3643 0
At 1 week after Quit day
Secondary outcome [11] 3644 0
Serious adverse events
Timepoint [11] 3644 0
At three weeks, three months and six months after Quit day.

Eligibility
Key inclusion criteria
Participants will be people from throughout New Zealand who smoke, who contact Quitline (by phone) for smoking cessation advice and assistance. Smokers will be eligible provided they: want to stop smoking within the next two weeks; have their first cigarette within 30 minutes of waking; are able to provide verbal consent; have a telephone.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women and women who are breastfeeding will be excluded from the trial. People will also be excluded from the trial if they meet any of the following criteria: current users of NRT products; current users of Zyban (buproprion), clonidine or nortriptyline; use only non-cigarette tobacco products (e.g. pipes, cigars); have had a myocardial infarction within the last three months; and have had unstable or progressive angina pectoris, Prinzmetal’s angina, severe cardiac arrhythmia or a stroke in acute phase.

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 computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified minimisation by sex, ethnicity and level of nicotine dependence (as determined by the time to their first cigarette - a key question in the Fagerstrom Tolerance Questionnaire)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Due to the nature of the intervention only single blinding (of researchers, not of participants) is possible.
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2007
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] 410 0
New Zealand
State/province [1] 410 0

Funding & Sponsors
Funding source category [1] 1656 0
Government body
Name [1] 1656 0
The Health Research Council of New Zealand
Country [1] 1656 0
New Zealand
Funding source category [2] 1657 0
Charities/Societies/Foundations
Name [2] 1657 0
The National Heart Foundation of New Zealand
Country [2] 1657 0
New Zealand
Primary sponsor type
University
Name
Clinical Trials Research Unit, School of Population Health, Auckland University
Address
Private Bag 92019, Auckland
Country
New Zealand
Secondary sponsor category [1] 1464 0
University
Name [1] 1464 0
The Auckland Tobacco Control Research Centre, School of Population Health, University of Auckland and Health New Zealand Ltd, Christchurch
Address [1] 1464 0
Private Bag 92019, Auckland
Country [1] 1464 0
New Zealand

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 27344 0
Address 27344 0
Country 27344 0
Phone 27344 0
Fax 27344 0
Email 27344 0
Contact person for public queries
Name 10599 0
Dr Colin Howe
Address 10599 0
Clinical Trials Research Unit,
School of Population Health
University of Auckland,
Private Bag 92019,
Auckland 1142
Country 10599 0
New Zealand
Phone 10599 0
64 9 373 7599 ext. 84765
Fax 10599 0
64 9 373 1710
Email 10599 0
[email protected]
Contact person for scientific queries
Name 1527 0
Dr Natalie Walker
Address 1527 0
Clinical Trials Research Unit,
School of Population Health
University of Auckland,
Private Bag 92019,
Auckland 1142
Country 1527 0
New Zealand
Phone 1527 0
64 3 383 5853
Fax 1527 0
64 3 383 5853
Email 1527 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
SourceTitleYear of PublicationDOI
EmbaseDoes improved access and greater choice of nicotine replacement therapy affect smoking cessation success? Findings from a randomized controlled trial.2011https://dx.doi.org/10.1111/j.1360-0443.2011.03419.x
N.B. These documents automatically identified may not have been verified by the study sponsor.