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Trial registered on ANZCTR


Registration number
ACTRN12606000463572
Ethics application status
Approved
Date submitted
27/09/2006
Date registered
6/11/2006
Date last updated
30/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A cross-over trial of the acceptability and effect on smoking reduction of snus, novel nicotine pouch substitute, and nicotine gum in heavy New Zealand smokers
Scientific title
A cross-over trial of the acceptability and effect on smoking reduction of snus, novel nicotine pouch (sachet) substitute, and nicotine gum in heavy New Zealand smokers
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco use disorder 1438 0
Nicotine addiction 1439 0
Smoking reduction 1440 0
Condition category
Condition code
Mental Health 1535 1535 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cross-over trial of 2 weeks of snus (1g of tobacco which contains 5mg of nicotine) ad lib (the frequency of administration is left up to each individual to decide so that each person can tailor the dose to his or her individual nicotine addiction) placed under upper lip, 2 weeks of novel nicotine pouch (4mg nicotine in a sachet) ad lib placed under upper lip, and 2 weeks of nicotine gum (4mg nicotine). The washout period is the first week of each two week arm of the trial in the sense that we will discard the diary entries from the first week of each arm, and only analyse the diary entries of product use and cigarette smoking from the second week. This approach has been taken to help participants develop a routine of keeping a daily diary.
Intervention code [1] 1379 0
Treatment: Drugs
Comparator / control treatment
Cross-over trial, so nicotine gum is compared to Zonnic pouch (the pouch is a small sachet), is compared to snus.
Control group
Active

Outcomes
Primary outcome [1] 2118 0
The primary outcome is the acceptibiliy of the products. This is measured by the amount of product that subjects use each fortnight, and the Cigarette Evaluation Scale scores. This outcome is measured at the end of each treatment fortnight.
Timepoint [1] 2118 0
The timepoin is that this outcome is measured at the end of each fortnight of products used.
Primary outcome [2] 2119 0
Reduction in number of cigarettes smoked per day in the last week of each of the three treatment fortnights, compared tot he amount smoked in the lead-in week. The amount smoked is recorded by self-report of diary cards.
Timepoint [2] 2119 0
Timepoint is that the reductioon in cigaettes smoked is measured as the amount smoked in the last week of each fortnight of treatment compared to the amount smoked in the lead-in week.
Secondary outcome [1] 3661 0
A secondary outcome will be the Minnesota Nicotine Withdrawal Scale (MNWS) scores for each of the three products. The scores of one product can be compared with the scores of the other products to see which products are most effective at inhibiting withdrawal symptoms.
Timepoint [1] 3661 0
The MNWS scores are tested on the last day of each of the three treatment fortnights.

Eligibility
Key inclusion criteria
People who smoke ten or more cigarettes per day.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Use of bupropion (Zyban) or other nicotine replacement therapies in the previous 3 months. Any history of cardiovascular disease, or psychiatric disease..

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2 / 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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1673 0
Charities/Societies/Foundations
Name [1] 1673 0
Asthma & Respiratory Foundation of New Zealand
Address [1] 1673 0
PO Box 1459
Wellington 6140
Country [1] 1673 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 7343
Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 1476 0
University
Name [1] 1476 0
Wellington School of Medicine
Address [1] 1476 0
PO Box 7343
Wellington 6242
Country [1] 1476 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3120 0
The New Zealand Central Regional Ethics Committee
Ethics committee address [1] 3120 0
Ethics committee country [1] 3120 0
New Zealand
Date submitted for ethics approval [1] 3120 0
Approval date [1] 3120 0
19/10/2006
Ethics approval number [1] 3120 0
CEN/06/07/069

Summary
Brief summary
The primary purpose of this study is to test the acceptability of snus, compared to nicotine pouch (the pouch is like a sachet), compared to nicotine gum, and the degree to which each of these products reduces the number of cigarettes that people smoke. The hypothesis is that people will find snus and the nicotine pouch more acceptable than nicotine gum, and that the snus and the nicotine pouch will result in a larger reduction in number of cigarettes smoked per day than is acheived using nicotine gum. We have no hypothesis about the relative accepability or smoking reduction effectiveness of snus compared to nicotine pouch.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27606 0
Address 27606 0
Country 27606 0
Phone 27606 0
Fax 27606 0
Email 27606 0
Contact person for public queries
Name 10568 0
Brent Caldwell
Address 10568 0
Wellington School of Medicine
23A Mein Street
Newtown Wellington
Country 10568 0
New Zealand
Phone 10568 0
+64 4 3855541
Fax 10568 0
Email 10568 0
brent.caldwell@otago.ac.nz
Contact person for scientific queries
Name 1496 0
Professor Julian Crane
Address 1496 0
Wellington School of Medicine
23A Mein Street
Newtown Wellington
Country 1496 0
New Zealand
Phone 1496 0
+64 4 3855541
Fax 1496 0
Email 1496 0
julian.crane@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