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Trial registered on ANZCTR


Registration number
ACTRN12612000914864
Ethics application status
Approved
Date submitted
27/08/2012
Date registered
28/08/2012
Date last updated
28/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Nicotine Reduction Pilot Study

To determine if a price differential based on nicotine content reduces cigarette consumption in smokers who are unmotivated to quit.
Scientific title
Nicotine Reduction Study using very low nicotine content cigarettes (VLNC) in smokers who are unmotivated to quit
Secondary ID [1] 281099 0
Nil
Universal Trial Number (UTN)
Trial acronym
ENRIQ- Evaluation of Nicotine Reduction in Queenstown
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation 287257 0
Condition category
Condition code
Public Health 287584 287584 0 0
Epidemiology
Mental Health 287592 287592 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention arm: Very low nicotine content (VLNC) cigarettes will be given to the intervention group for eight weeks. The number of VLNC provided will be based on the number of nicotine containing cigarettes they usually smoke at baseline.

Each participant will be able to smoke as many of the VLNC as they wish during the eight weeks intervention.
Intervention code [1] 285552 0
Treatment: Other
Intervention code [2] 285560 0
Lifestyle
Comparator / control treatment
Active arm: Will be requested to purchase their usual brand of cigarettes over the eight weeks. They will be asked to smoke as many of their usual brand of cigarettes as they wish during the eight weeks.
Control group
Active

Outcomes
Primary outcome [1] 287840 0
The change from baseline in the mean number of regular cigarettes smoked in the past week, measured at 12 weeks. Each participant will be requested daily via text message to submit the number of cigarettes they smoked the day before.
Timepoint [1] 287840 0
12 weeks
Secondary outcome [1] 298914 0
Mean number of regular cigarettes smoked each week calculated by adding daily text messages results of the number of cigarettes smoked or where no text is received via telephone call request for the information (self reported).
Timepoint [1] 298914 0
1,2,3,4,5,6,9 and 12 weeks
Secondary outcome [2] 298915 0
Salivary cotinine measurement
Timepoint [2] 298915 0
1,2,3,4,5,6,9 and 12 weeks
Secondary outcome [3] 298916 0
Nicotine dependence, including time to first cigarette using the Fagerstrom Test for Nicotine dependence questionnaire.
Timepoint [3] 298916 0
6 and 12 weeks
Secondary outcome [4] 298917 0
Smoking satisfaction and craving reduction using the modified Cigarette Evaluation Questionnaire (mCEQ).
Timepoint [4] 298917 0
6 and 12 weeks
Secondary outcome [5] 298918 0
The behavioural components of smoking addiction using the Glover Nilsson Smoking Behavioural Questionnaire.
Timepoint [5] 298918 0
6 and 12 weeks
Secondary outcome [6] 298919 0
Autonomy over smoking using the AUTOS Questionnaire
Timepoint [6] 298919 0
6 and 12 weeks
Secondary outcome [7] 298920 0
Changes in the physical signs and symptoms of nicotine withdrawal and craving
Timepoint [7] 298920 0
6 and 12 weeks
Secondary outcome [8] 298921 0
Self-rated chances of quitting using the Self- efficacy questionnaire (1-5 scale).
Timepoint [8] 298921 0
6 and 12 weeks
Secondary outcome [9] 298922 0
Quitting behaviour: 7-day point prevalence continuous abstinence rates, defined as the proportion of particpants who consumed no "regular" cigarettes (not even a single puff) in the previous seven days (self reported). Use of nicotine and non-nicotine methods of quitting support via questionnaire.
Timepoint [9] 298922 0
6 and 12 weeks
Secondary outcome [10] 298923 0
Views on a nicotine reduction strategy collected via questionnaire covering concerns, likes, dislikes etc.
Timepoint [10] 298923 0
12 weeks

Eligibility
Key inclusion criteria
they do not wish to quit smoking in the next three months
they are at least 18 years of age
they are daily smokers
their time to first cigarette is within 30 minutes of waking
they are able to provide written consent
they have a mobile phone they can use daily
they have a mobile phone that is capable of receiving and sending text messages
they intend to reside in the Otago/Southland region for the next six months
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant women
Women who are breastfeeding
Current users of NRT products (including electronic cigarettes with nicotine)
Currently enrolled in a quit smoking programme (such as Quitline)
Current users of non-nicotine based cessation therapies (e.g. buproprion, clonidine, nortriptyline or varenicline)
Only use non-cigarette tobacco products (e.g. pipes, cigars).
One person per household can be recruited into the study.

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)
Participants will be centrally randomised by computer using allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised using dynamic allocation/stratified minimisation by sex, ethnicity, and level of nicotine dependence (as determined by the Fagerstrom Test for Nicotine Dependence)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
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] 4511 0
New Zealand
State/province [1] 4511 0
Otago region (South Island)

Funding & Sponsors
Funding source category [1] 285884 0
Government body
Name [1] 285884 0
Health Reseach Council (HRC NZ)
Address [1] 285884 0
PO Box 5541, Wellesley Street, Auckland 1141
Country [1] 285884 0
New Zealand
Primary sponsor type
University
Name
National Institute For Health Innovation (NIHI)
Address
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 284709 0
None
Name [1] 284709 0
Address [1] 284709 0
Country [1] 284709 0
Other collaborator category [1] 277039 0
University
Name [1] 277039 0
Centre for Tobacco Control Research
Address [1] 277039 0
School of Population Health Research
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country [1] 277039 0
New Zealand
Other collaborator category [2] 277040 0
Commercial sector/Industry
Name [2] 277040 0
ESR Ltd
Address [2] 277040 0
Hampstead Road
Sandringham
Auckland 1142
Country [2] 277040 0
New Zealand
Other collaborator category [3] 277041 0
Commercial sector/Industry
Name [3] 277041 0
Global Public Health Ltd
Address [3] 277041 0
Po Box 82
Glenorchy 9350
Country [3] 277041 0
New Zealand
Other collaborator category [4] 277042 0
Commercial sector/Industry
Name [4] 277042 0
Health New Zealand Ltd
Address [4] 277042 0
36 Winchester St, Lyttelton

Christchurch 8082
Country [4] 277042 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287913 0
Heath And Disabilty Ethics Committee, Northern B
Ethics committee address [1] 287913 0
Ministry of Health
1 The Terrace
PO BOX 5013
Wellington 6011
Ethics committee country [1] 287913 0
New Zealand
Date submitted for ethics approval [1] 287913 0
01/10/2012
Approval date [1] 287913 0
01/11/2012
Ethics approval number [1] 287913 0
12/NTB/48

Summary
Brief summary
In order to reach the government’s goal to have a smokefree New Zealand by 2025, radical changes need to be made at both the policy and practical level as the ‘business as usual’ approach to smoking cessation will not achieve the goal. A nicotine reduction strategy is one approach that may help reduce the level of nicotine dependence in smokers, resulting in a greater chance of quitting. However, insufficient data exist on what would happen if a nicotine reduction policy was implemented, or what form such a policy should take.
Trial website
http://www.turanga.org.nz/

http://nihi.auckland.ac.nz/index.php
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34625 0
Dr Natalie Walker
Address 34625 0
University of Auckland
National Institute For Health Innovation
Private Bag 92019
Auckland 1142
Country 34625 0
New Zealand
Phone 34625 0
+64 9 923 9884
Fax 34625 0
Email 34625 0
n.walker@nihi.auckland.ac.nz
Contact person for public queries
Name 17872 0
Dr Dr Colin Howe
Address 17872 0
NIHI
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country 17872 0
New Zealand
Phone 17872 0
+64 9 923 4765
Fax 17872 0
+64 9 373 1710
Email 17872 0
c.howe@nihi.auckland.ac.nz
Contact person for scientific queries
Name 8800 0
Dr Dr Natalie Walker
Address 8800 0
NIHI
University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
Country 8800 0
New Zealand
Phone 8800 0
+64 9 923 9884
Fax 8800 0
+64 9 373 1710
Email 8800 0
n.walker@nihi.auckland.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