Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000054617
Ethics application status
Approved
Date submitted
7/01/2014
Date registered
20/01/2014
Date last updated
20/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study of providing adult smokers, who smoke at least one cigarette per day, the opportunity to sample a range of nicotine replacement therapies (NRTs) in everyday non-medical community locations, to determine if this is acceptable to smokers, and whether it increases their motivation to quit smoking, encourages them to use NRTs, and helps them to quit smoking and remain abstinent for three months.
Scientific title
A pilot uncontrolled single arm non-randomised open-label trial of the acceptability and effect on motivation to quit and compliance with use of nicotine replacement therapy of supplying nicotine replacement therapies to smokers in community locations regardless of their motivation to quit smoking.
Secondary ID [1] 283866 0
Nil
Universal Trial Number (UTN)
U1111-1145-4390
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco dependence 290848 0
Smoking addiction 290849 0
Condition category
Condition code
Mental Health 291212 291212 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial will consist of kiosks in community locations where smokers go about their everday lives (such as shopping malls), which are staffed by trained quit coaches. People who smoke at least once per day, will be given the opportunity to sample a range of nicotine replacement therapies while being guided in the appropriate manner of using them by an expert coach. They can choose from the following products: Nicotine patch (21mg, 14mg, 7mg); nicotine gum (2mg, 4mg); nicotine lozenge (2mg, 1mg); nicotine mouthspray (QuickMist) 1mg/spray; Nicorette Inhalator 15mg. They can choose to sample as many products as they wish, however, if participants have not voluntarily chosen to try wearing a patch, they will be gently encouraged to do so, although they can decline to try wearing a patch if they do not want to. If participatns wish, they may take a free sample of a week's worth of as many of the products as they want (however, they must be products that they have chosen to sample at the kiosk under supervision of an expert coach).
Intervention code [1] 288543 0
Treatment: Drugs
Comparator / control treatment
There is no comparator or control treatment as this is a single-arm trial.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291202 0
7-day point prevalence (not smoking even a puff in the past 7 days). This will be by self-report (either by telephone or by visitng the kiosk at the mall), and if the subjects are willing to visit the kiosk at the mall, this will be verified by an exhaled carbon monoxide level of less than 10 parts per million.
Timepoint [1] 291202 0
Weeks 1, 2, 4, 8, and 18 after first attendance at the kiosk. At these time-points every effort will be make to encourage participants to attend the kiosk to provide carbon monoxide verification of their abstinence status (abstinence defined as <10ppm), however if subjects are unwilling to visit the mall, this outcome will be measured by self-report over the telephone.
Primary outcome [2] 291203 0
Amount of nicotine replacement therapy/therapies used, measured by self-report via telephone or at visit to the kiosk locations.
Timepoint [2] 291203 0
Weeks 1, 2, 4, 8, and 18 after attending the kiosk.
Secondary outcome [1] 306226 0
Acceptability of nicotine replacement therapies, rated on ad hoc Likert scales
Timepoint [1] 306226 0
weeks 1, 2, 4, 8, and 18 after first visit to the kiosk
Secondary outcome [2] 306227 0
Duration of abstinence (record the number of days of not smoking since previous follow-up)
Timepoint [2] 306227 0
weeks 1, 2, 4, 8, and 18 after first visit to the kiosk

Eligibility
Key inclusion criteria
18 years or older, and report smoking daily
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-daily smokers

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)
Subjects will be enrolled if they meet the inclusion criteria, and will be allocated to treatment according to what products they would like to use (this is a non-controlled study).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Non-controlled study, and subjects choose which therapies they would like to use.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Logist regression and generalised linear models will be used to determine what factors influenced abstinence and the amount of nicotine replacement therapies that were used.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/01/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment outside Australia
Country [1] 5725 0
New Zealand
State/province [1] 5725 0
Lower North Island

Funding & Sponsors
Funding source category [1] 288512 0
Government body
Name [1] 288512 0
Ministry of Health
Country [1] 288512 0
New Zealand
Primary sponsor type
Government body
Name
Ministry of Health
Address
Tobacco Control Programme
Community Health Service Improvement
Sector Capability and Implementation
Ministry of Health
133 Molesworth Street
Thorndon
Wellington 6011
Country
New Zealand
Secondary sponsor category [1] 287218 0
None
Name [1] 287218 0
Address [1] 287218 0
Country [1] 287218 0
Other collaborator category [1] 277751 0
University
Name [1] 277751 0
University of Otago, Wellington
Address [1] 277751 0
23a Mein Street
Newtown
Wellington 6041
Country [1] 277751 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290375 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 290375 0
Health and Disability Ethics Committees
1 The Terrace
PO Box 5013
Wellington
6011
Ethics committee country [1] 290375 0
New Zealand
Date submitted for ethics approval [1] 290375 0
Approval date [1] 290375 0
31/07/2013
Ethics approval number [1] 290375 0
13/CEN/108

Summary
Brief summary
This is a pilot study of making a range of nicotine replacement therapies available to smokers in locations where they go about their everyday lives, regardless of their level of motivation to quit smoking. The hypothesis is that giving smokers the opportunity to sample a range of therapies, under the guidance of an expert coach, will increase their motivation to quit, increase their usage of nicotine replacement therapy, and lead them to try to quit smoking.
Trial website
www.otago.ac.nz/enjoy
Trial related presentations / publications
None so far.
Public notes
None.

Contacts
Principal investigator
Name 45378 0
Dr Brent Caldwell
Address 45378 0
University of Otago, Wellington
Department of Medicine
23a Mein Street
Newtown
Wellington 6041
Country 45378 0
New Zealand
Phone 45378 0
+64 (0)4 9186041
Fax 45378 0
Email 45378 0
[email protected]
Contact person for public queries
Name 45379 0
Dr Brent Caldwell
Address 45379 0
University of Otago, Wellington
Department of Medicine
23a Mein Street
Newtown
Wellington 6041
Country 45379 0
New Zealand
Phone 45379 0
+64 (0)4 9186041
Fax 45379 0
Email 45379 0
[email protected]
Contact person for scientific queries
Name 45380 0
Dr Brent Caldwell
Address 45380 0
University of Otago, Wellington
Department of Medicine
23a Mein Street
Newtown
Wellington 6041
Country 45380 0
New Zealand
Phone 45380 0
+64 (0)4 9186041
Fax 45380 0
Email 45380 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.