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Trial registered on ANZCTR


Registration number
ACTRN12612001210864
Ethics application status
Approved
Date submitted
15/11/2012
Date registered
15/11/2012
Date last updated
28/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Can using nicotine as a long-term substitute enhance smoking cessation over using it only as a cessation aid?
Scientific title
An open-label randomised pragmatic policy trial examining effectiveness of short-term use of Nicotine Replacement Therapy (NRT) vs short- or long-term use of NRT vs short- or long-term use of NRT or electronic nicotine delivery systems for smoking cessation in cigarette smokers.
Secondary ID [1] 281549 0
Nil
Universal Trial Number (UTN)
U1111-1137-0793
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco Addiction 287821 0
Smoking cessation 287822 0
Condition category
Condition code
Public Health 288169 288169 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Condition A (Comparator): Participants in this condition will receive: 1) A factsheet that explains the relative harmfulness of NRT compared to cigarettes; 2) A free sample of NRT products (1-2 days supply of choice of any three of gum, lozenge, inhaler or mouthspray) and instructions for use of the products. Participants will be told the products are designed to help them quit, and that the recommended use is for 8-12 weeks. Advice on recommended dose will be provided and the amount supplied for free will be determined from the participant’s cigarette intake and the recommended dosage schedule. However, participants will be able to use their discretion as to their individual dose. Participants may choose one of the products or a combination of two to use for a quit attempt; 3) Approximately three week’s worth of the participant's chosen NRT product (or a combination of two products, if this is their preference) will be supplied for free; and 4) Access to these products for a further 6 months at a price that reflects their lower harmfulness compared to cigarettes (ie significantly cheaper than retail price of cigarettes and lower than current retail prices for NRT). These purchases will be made via a secure website controlled by the research team. Condition B: Participants in this condition will receive: 1) A factsheet that explains the relative harmfulness of NRT compared to cigarettes similar to that provided for Condition A, but with further information on the benefits of both options (short term quit aid or long-term substitute) compared to smoking. It will emphasise complete cessation as the best option from a health perspective; 2) A free sample of NRT products (1-2 days supply of choice of any three of gum, lozenge, inhaler or mouthspray) and instructions for use of the products. Participants will be told how to use the products as a short term quitting aid (recommended use for 8-12 weeks), but also encouraged to continue using the product if they find they need to in order to refrain from smoking. Advice on recommended dose will be provided and the amount supplied for free will be determined from the participant’s cigarette intake and the recommended dosage schedule. However, participants will be able to use their discretion as to their individual dose. Participants may choose one of the products or a combination of two to use for a quit attempt; 3) Approximately three week’s worth of the participant's chosen NRT product (or a combination of two products, if this is their preference) will be supplied for free; and 4) Access to these products for a further 6 months at a price that reflects their lower harmfulness compared to cigarettes (ie significantly cheaper than retail price of cigarettes and lower than current retail prices for NRT). These purchases will be made via a secure website controlled by the research team. Condition C: Participants in this condition will receive: 1) A factsheet that explains the relative harmfulness of NRT compared to cigarettes with information on the benefits of both options (short term quit aid or long-term substitute) compared to smoking similar to that provided for Condition B, but with additional details on the risk profile of Electronic Nicotine Delivery Systems compared to both NRT and stopping all nicotine use. It will emphasise complete cessation as the best option from a health perspective; 2) A free sample of 1-2 days supply each of up to four products and instructions for use of the products. Participants may select from NRT products (gum, lozenge, inhaler, mouthspray) and an electronic nicotine delivery system. Participants will be told how to use the products as a short term quitting aid (recommended use for 8-12 weeks), but also encouraged to continue using the product if they find they need to in order to refrain from smoking. Advice on recommended dose will be provided and the amount supplied for free will be determined from the participant’s cigarette intake and the recommended dosage schedule. However, participants will be able to use their discretion as to their individual dose. Participants may choose one of the products or a combination of two to use for a quit attempt; 3) Approximately three week’s worth of the participant's chosen NRT product (or a combination of two products, if this is their preference) will be supplied for free; and 4) Access to these products for a further 6 months at a price that reflects their lower harmfulness compared to cigarettes (ie significantly cheaper than retail price of cigarettes and lower than current retail prices for NRT). These purchases will be made via a secure website controlled by the research team.
Intervention code [1] 286064 0
Treatment: Drugs
Intervention code [2] 286065 0
Treatment: Devices
Intervention code [3] 286066 0
Lifestyle
Comparator / control treatment
Condition A (Comparator): Participants in this condition will receive: 1) A factsheet that explains the relative harmfulness of NRT compared to cigarettes; 2) A free sample of NRT products (1-2 days supply of choice of up to three of gum, lozenge, inhaler and mouthspray) and instructions for use of the products. Participants will be told the products are designed to help them quit, and that the recommended use is for 8-12 weeks. Advice on recommended dose will be provided and the amount supplied for free will be determined from the participant’s cigarette intake and the recommended dosage schedule. However, participants will be able to use their discretion as to their individual dose. Participants may choose one of the products or a combination of two to use for a quit attempt; 3) Approximately three week’s worth of the participant's chosen NRT product (or a combination of two products, if this is their preference) will be supplied for free; and 4) Access to these products for a further 6 months at a price that reflects their lower harmfulness compared to cigarettes (ie significantly cheaper than retail price of cigarettes and lower than current retail prices for NRT). These purchases will be made via a secure website controlled by the research team.
Control group
Active

Outcomes
Primary outcome [1] 288370 0
Percentage in each Condition who have continuous abstinence (not smoked for 6 months or more) with or without current/recent NRT or electronic nicotine delivery system use, measured by self-report through questionnaires (questions developed by the research team).
Timepoint [1] 288370 0
6 months
Primary outcome [2] 288371 0
Percentage in each Condition who have continuous smoking abstinence for 6 months or more with no NRT or electronic nicotine delivery system use for 3 months or more, measured by self-report through questionnaires (questions developed by the research team).
Timepoint [2] 288371 0
6 months
Secondary outcome [1] 299986 0
seven-day point prevalence abstinence measures of the above primary outcomes, measured by self-report through questionnaires (questions developed by the research team).
Timepoint [1] 299986 0
12 months
Secondary outcome [2] 299987 0
The proportion of each Condition concurrently using NRT and cigarettes, the quantity of each consumed, their interest in quitting smoking, and interest in eventually quitting all NRT, measured by self-report through questionnaires (questions developed by the research team).
Timepoint [2] 299987 0
12 months
Secondary outcome [3] 299988 0
The proportion of Condition C concurrently using the electronic nicotine delivery system and tobacco cigarettes, the quantity of each consumed, their interest in quitting smoking, and interest in eventually quitting all use, measured by self-report through questionnaires (questions developed by the research team).
Timepoint [3] 299988 0
12 months
Secondary outcome [4] 299989 0
The quantity of cigarettes consumed by current smokers as a function of NRT or electronic nicotine delivery system use in each Condition, and their interest in quitting smoking, measured by self-report through questionnaires (questions developed by the research team).
Timepoint [4] 299989 0
12 months
Secondary outcome [5] 299990 0
The proportion of each Condition that order a trial product, what product is ordered, the amount used over what period, measured by self-report through questionnaires (questions developed by the research team) and a review of products sent to the participants.
Timepoint [5] 299990 0
12 months
Secondary outcome [6] 299991 0
The proportions of each Condition that make a quit attempt and length of all quit attempts made (both from smoking and all nicotine use), measured by self-report through questionnaires (questions developed by the research team).
Timepoint [6] 299991 0
12 months

Eligibility
Key inclusion criteria
Current daily smokers (at least 6 cigarettes/day); ability to read and understand English; agree to receive samples of nicotine products and to try the samples; and willing to complete surveys over 12 months.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Currently being treated for Serious cardiovascular disease (eg heart disease, stroke), Cancer, A mental health condition that is being treated with regular medication, High blood pressure that is not controlled, Have a stomach ulcer, Have kidney or liver disease, Have an overactive thyroid or adrenal gland cancer, Use insulin for diabetes, Have asthma or chronic throat disease, pregnant or planning to become pregnant or expecting to be breastfeeding within the next 12 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)
Current smokers will be recruited from a commercial market research panel and sent an invitation to participate in the trial with a URL link to the online screening questionnaire. Eligibility will be determined by a computer based on their answers to the screening questionnaire.

Eligible participants will be required to confirm consent and then complete a baseline survey on smoking history, health status and quitting intentions. They will then be automatically randomised to one of the three conditions (A, B or C) by a computer generated random number sequence. IE allocation will be concealed as it will be an automated process performed by a computer. Participants will only be provided with information that is relevant to their allocated condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated random number sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
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)
ACT,NSW,QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 286332 0
Government body
Name [1] 286332 0
National Health and Medical Research Council
Address [1] 286332 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 286332 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
UQ Centre for Clinical Research
The University of Queensland
Building 71/918
Royal Brisbane and Women's Hospital Site
Herston Qld 4029
Country
Australia
Secondary sponsor category [1] 285124 0
Charities/Societies/Foundations
Name [1] 285124 0
The Cancer Council Victoria
Address [1] 285124 0
The Cancer Council Victoria
100 Drummond St
Carlton Vic 3053
Country [1] 285124 0
Australia
Other collaborator category [1] 277178 0
Individual
Name [1] 277178 0
Professor Wayne Hall
Address [1] 277178 0
UQ Centre for Clinical Research
The University of Queensland
Building 71/918
Royal Brisbane and Women's Hospital Site
Herston Qld 4029
Country [1] 277178 0
Australia
Other collaborator category [2] 277179 0
Individual
Name [2] 277179 0
Associate Professor Jan Barendregt
Address [2] 277179 0
School of Population Health
University of Queensland
Herston Road
Herston QLD 4006
Country [2] 277179 0
Australia
Other collaborator category [3] 277180 0
Individual
Name [3] 277180 0
Associate Professor Chris Bullen
Address [3] 277180 0
National Institute for Health Innovation
Level 4, School of Population Health
Tamaki Campus
The University of Auckland
261 Morrin Road
Glen Innes Auckland 1072
Country [3] 277180 0
New Zealand
Other collaborator category [4] 277181 0
Individual
Name [4] 277181 0
Dr Natalie Walker
Address [4] 277181 0
National Institute for Health Innovation
Level 4, School of Population Health
Tamaki Campus
The University of Auckland
261 Morrin Road
Glen Innes Auckland 1072
Country [4] 277181 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288408 0
The University of Queensland Human Medical Research Ethics Committee
Ethics committee address [1] 288408 0
Human Ethics
Research Management Office
UQ Research and Innovation
Cumbrae-Stewart Building (#72)
The University of Queensland
BRISBANE QLD 4072
Ethics committee country [1] 288408 0
Australia
Date submitted for ethics approval [1] 288408 0
Approval date [1] 288408 0
08/11/2012
Ethics approval number [1] 288408 0
2012001117

Summary
Brief summary
Many smokers who try to quit fail in their attempt. Medicinal nicotine is currently only used as a short-term quit aid. This trial will test if offering smokers the option of using these products as long-term substitutes for cigarettes will help more smokers to successfully quit. We will also determine if offering smokers electronic nicotine delivery systems in addition to medicinal nicotine products further increases the number of smokers who quit successfully.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34959 0
Dr Coral Gartner
Address 34959 0
UQCCR, Building 71/918 RBWH Site, The University of Queensland, Herston Qld 4029
Country 34959 0
Australia
Phone 34959 0
61 7 33465478
Fax 34959 0
+61 7 3346 5598
Email 34959 0
c.gartner@uq.edu.au
Contact person for public queries
Name 18206 0
Mr Doug Fraser
Address 18206 0
UQ Centre for Clinical Research
The University of Queensland
Building 71/918
Royal Brisbane and Women's Hospital Site
Herston Qld 4029
Country 18206 0
Australia
Phone 18206 0
+61 7 33465475
Fax 18206 0
+61 7 3346 5598
Email 18206 0
d.fraser2@uq.edu.au
Contact person for scientific queries
Name 9134 0
Dr Dr Coral Gartner
Address 9134 0
UQ Centre for Clinical Research
The University of Queensland
Building 71/918
Royal Brisbane and Women's Hospital Site
Herston Qld 4029
Country 9134 0
Australia
Phone 9134 0
+61 7 33465478
Fax 9134 0
+61 7 3346 5598
Email 9134 0
c.gartner@uq.edu.au

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