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Trial registered on ANZCTR


Registration number
ACTRN12609000482268
Ethics application status
Approved
Date submitted
5/06/2009
Date registered
18/06/2009
Date last updated
2/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised controlled trial of Zonnic and nicotine patch (ZAP) in smoking cessation
Scientific title
Randomised placebo-controlled trial of Zonnic and nicotine patch in heavy smokers for smoking cessation
Secondary ID [1] 283666 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco Addiction 236929 0
Smoking Cessation 236930 0
Condition category
Condition code
Mental Health 237289 237289 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Zonnic (peppermit flavoured nicotine mouthspray) plus nicotine patch compared to placebo-Zonnic plus active nicotine patch. Zonnic for 6 months, nicotine patch for 5 months. Zonnic contains 1mg nicotine per spray, use at the discretion of the participant for first 5 months, wean during 6th month. Use patches daily with dose titrated to amount smoked using standard schedule recommended by manufacturer. In 5th month wean from patches in step-wise manner as laid out by manufacturer. Zonnic and patches both start at the second clinic visit. Quit date is the first quit day at the end of the 3 weeks of smoking reduction.
Intervention code [1] 236719 0
Treatment: Drugs
Comparator / control treatment
Placebo Zonnnic plus active nicotine patch. Placebo Zonnic is identical to active Zonnic except that it does not contain nicotine, and instead contains a small amount of capsacian. Placebo Zonnic is used according to the same frequency and weaning protocol as Active Group. The patch used in the control group is the same active patch and same dose and frequency as that in the Active Group. Both patch and placebo-Zonnic start at the 2nd clinic visit. Quit date is the first day of smoking abstinence at the end of the smoking reduction period.
Control group
Placebo

Outcomes
Primary outcome [1] 238099 0
Post-cessation smoking abstinence assessed by self-report and hair nicotine. Hair nicotine testing involves the collection of a sample of hair from the head, which is analysed in the laboratory to measure its nicotine content.
Timepoint [1] 238099 0
12 months post smoking cessation date.
Primary outcome [2] 238100 0
Continuous smoking abstinence between quit date and end of study by self-report
Timepoint [2] 238100 0
Over the 12 month period after smoking cessation. During this period continuous smoking abstinence is measured by self-report on daily diary cards from Week 2 to Week 5, and for a fortnight every month thereafter. It is biochemically verified by exhaled carbon monoxide tests at each clinic visit (1, 3, 6, and 12 months post smoking cessation) and by the nicotine content of a sample of hair taken from the head at 12 months post-smoking cessation.
Secondary outcome [1] 242304 0
Abstinence rates at 3 months verified by exhaled carbon monoxide
Timepoint [1] 242304 0
3 months post smoking cessation.
Secondary outcome [2] 242305 0
Abstinence rates at 6 months assessed by exhaled carbon monoxide.
Timepoint [2] 242305 0
6 months post smoking cessation.
Secondary outcome [3] 242306 0
Continued use of Zonnic after the planned stop date, assessed by self-report.
Timepoint [3] 242306 0
Between stop date (after 6 months use of Zonnic) and end of the study. This will be assessed by self-report at clinic visits at 3, 6 and 12 months post smoking-cessation.
Secondary outcome [4] 242387 0
Correlation between 12 month quit rate, and the magnitude of reduction in brief-Questionnaire of Smoking Urges score pre and post first use of Zonnic at Visit 2.
Timepoint [4] 242387 0
Visit 2 is the start of using Zonnic, and 12 month quit rate is determined 12 months post smoking cessation.
Secondary outcome [5] 263580 0
Abstinence rates at 1 month post quit.
Timepoint [5] 263580 0
The 1 month quit rate will be assessed one month after the subject's quit date, which is 3 weeks after they start taking the nicotine replacement therapy

Eligibility
Key inclusion criteria
Smokers of 15 or more cigarettes per day, with Fagerstrom Test of Nicotine Dependence score of 3 or greater.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any serious medical condition, history of peptic ulcer, cardiovascular disease, pregnancy, breastfeeding, inadequate contraception.

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)
Random numbers generated by computer when new subject meets inclusion criteria, study drugs are made up into sealed boxes labeled with random number. Boxes are made up by independent staff.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generated at moment of enrolment by computer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1827 0
New Zealand
State/province [1] 1827 0

Funding & Sponsors
Funding source category [1] 237110 0
Government body
Name [1] 237110 0
Health Research Council of New Zealand
Address [1] 237110 0
PO Box 5541
Wellesley Street
Auckland 1010
Country [1] 237110 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council of New Zealand
Address
PO Box 5541
Wellesley Street
Auckland 1010
Country
New Zealand
Secondary sponsor category [1] 4636 0
None
Name [1] 4636 0
Address [1] 4636 0
Country [1] 4636 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239209 0
Central Regional Ethics Committee
Ethics committee address [1] 239209 0
PO Box 5013
Wellington 6145
Ethics committee country [1] 239209 0
New Zealand
Date submitted for ethics approval [1] 239209 0
01/09/2006
Approval date [1] 239209 0
19/10/2006
Ethics approval number [1] 239209 0

Summary
Brief summary
We aim to test the effect on 12 month quit rates of adding Zonnic (a nicotine mouthspray) to nicotine patch therapy compared to nicotine patch therapy plus placebo Zonnic. Subjects will receive 5 months of nicotine patch, and 6 months of Zonnic. Subjects will reduce their smoking in the first month, then quit smoking and continue to use Zonnic and patches. Abstinence will be measured at 12 months post-cessationo and verified by plasma or hair nicotine.
Trial website
Trial related presentations / publications
Nil
Public notes
We have written a manuscript of the main results of this study, and submitted it to a journal, and it is currently under peer-review

Contacts
Principal investigator
Name 29710 0
Prof Julian Crane
Address 29710 0
University of Otago, Wellington
23a Mein Street
Newtown
Wellington 6021
New Zealand
Country 29710 0
New Zealand
Phone 29710 0
+64 (0)4 918 5258
Fax 29710 0
Email 29710 0
julian.crane@otago.ac.nz
Contact person for public queries
Name 12957 0
Dr Brent Caldwell
Address 12957 0
PO Box 7343
WELLINGTON 6242
Country 12957 0
New Zealand
Phone 12957 0
+6449186041
Fax 12957 0
Email 12957 0
brent.caldwell@otago.ac.nz
Contact person for scientific queries
Name 3885 0
Dr Brent Caldwell
Address 3885 0
PO Box 7343
WELLINGTON 6242
Country 3885 0
New Zealand
Phone 3885 0
+6449186041
Fax 3885 0
Email 3885 0
brent.caldwell@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary