Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02957786
Registration number
NCT02957786
Ethics application status
Date submitted
27/10/2016
Date registered
8/11/2016
Titles & IDs
Public title
Cytisine Versus Varenicline for Smoking Cessation
Query!
Scientific title
RAUORA: Cytisine Versus Varenicline for Smoking Cessation
Query!
Secondary ID [1]
0
0
UTN: U1111-1187-2838
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
RAUORA
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Cytisine
BEHAVIORAL - Behavioural support
Treatment: Drugs - Varenicline
Experimental: Cytisine plus behavioural support - 12-week course of cytisine capsules (1.5mg), with a decreasing dosing regimen (9mg/day for days 1-3, 7.5mg/day for days 4-12, 6mg/day for days 13-16, 4.5mg/day for days 17-20, 3.0mg/day from days 21-week 12).
Participants will be asked to reduce their smoking over the first four days of treatment so that they are not smoking at all by the fifth day, which will be their designated Quit date.
Participants will also withdrawal-orientated behavioural support (delivered by cessation advisors), in addition to brief cessation advice from the study-specific doctor (at the point that the prescription is provided) and community pharmacist (at the point the participant redeems their prescription).
Active comparator: Varenicline plus behavioural support - 12-week course of Varenicline tablets (0.5mg/1mg), with an increasing dosing regimen (0.5mg/day for days 1-3, 1.0mg/day for days 4-7, 2.0mg/day for day 8-week 12).
Participants will be asked to reduce their smoking over the first four days of treatment so that they are not smoking at all by the fifth day, which will be their designated Quit date.
Participants will also receive withdrawal-orientated behavioural support (delivered by cessation advisors), in addition to brief cessation advice from the study-specific doctor (at the point that the prescription is provided) and community pharmacist (at the point the participant redeems their prescription).
Treatment: Drugs: Cytisine
Cytisine tablets
BEHAVIORAL: Behavioural support
Withdrawal-orientated cessation support
Treatment: Drugs: Varenicline
Varenicline tablets
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
BEHAVIORAL
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Continuous abstinence from smoking
Query!
Assessment method [1]
0
0
Self-report of smoking not more than five cigarettes from the quit date, supported by biochemical validation using a carbon monoxide (CO) expired breath
Query!
Timepoint [1]
0
0
Six months post-quit date
Query!
Secondary outcome [1]
0
0
Continuous abstinence from smoking
Query!
Assessment method [1]
0
0
Self-report of smoking not more than five cigarettes from the quit date
Query!
Timepoint [1]
0
0
One month post-quit date
Query!
Secondary outcome [2]
0
0
Continuous abstinence from smoking
Query!
Assessment method [2]
0
0
Self-report of smoking not more than five cigarettes from the quit date
Query!
Timepoint [2]
0
0
Three months post-quit date
Query!
Secondary outcome [3]
0
0
Continuous abstinence from smoking
Query!
Assessment method [3]
0
0
Self-report of smoking not more than five cigarettes from the quit date, supported by biochemical validation using a carbon monoxide (CO) expired breath
Query!
Timepoint [3]
0
0
12 months post-quit date (in 2/3 of sample)
Query!
Secondary outcome [4]
0
0
7-day point prevalence abstinence from smoking
Query!
Assessment method [4]
0
0
Self-report of having smoked no cigarettes (not even a puff) in the past seven days.
Query!
Timepoint [4]
0
0
One month post-quit date
Query!
Secondary outcome [5]
0
0
7-day point prevalence abstinence from smoking
Query!
Assessment method [5]
0
0
Self-report of having smoked no cigarettes (not even a puff) in the past seven days.
Query!
Timepoint [5]
0
0
Three month post-quit date
Query!
Secondary outcome [6]
0
0
7-day point prevalence abstinence from smoking
Query!
Assessment method [6]
0
0
Self-report of having smoked no cigarettes (not even a puff) in the past seven days,supported by biochemical validation using a carbon monoxide (CO) expired breath.
Query!
Timepoint [6]
0
0
Six month post-quit date
Query!
Secondary outcome [7]
0
0
7-day point prevalence abstinence from smoking
Query!
Assessment method [7]
0
0
Self-report of having smoked no cigarettes (not even a puff) in the past seven days,supported by biochemical validation using a carbon monoxide (CO) expired breath.
Query!
Timepoint [7]
0
0
12 month post-quit date (in 2/3 of sample)
Query!
Secondary outcome [8]
0
0
Time to relapse back to smoking
Query!
Assessment method [8]
0
0
Defined as return to daily smoking.
Query!
Timepoint [8]
0
0
One month post-quit date
Query!
Secondary outcome [9]
0
0
Time to relapse back to smoking
Query!
Assessment method [9]
0
0
Defined as return to daily smoking.
Query!
Timepoint [9]
0
0
Three month post-quit date
Query!
Secondary outcome [10]
0
0
Time to relapse back to smoking
Query!
Assessment method [10]
0
0
Defined as return to daily smoking.
Query!
Timepoint [10]
0
0
Six month post-quit date
Query!
Secondary outcome [11]
0
0
Time to relapse back to smoking
Query!
Assessment method [11]
0
0
Defined as return to daily smoking.
Query!
Timepoint [11]
0
0
12 month post-quit date (in 2/3 of sample)
Query!
Secondary outcome [12]
0
0
Cigarette withdrawal
Query!
Assessment method [12]
0
0
The physical signs and symptoms associated with nicotine withdrawal over the last week, measured using the Mood and Physical Symptoms Scale (MPSS)
Query!
Timepoint [12]
0
0
One month post-quit date
Query!
Secondary outcome [13]
0
0
Cigarette withdrawal
Query!
Assessment method [13]
0
0
The physical signs and symptoms associated with nicotine withdrawal over the last week, measured using the Mood and Physical Symptoms Scale (MPSS)
Query!
Timepoint [13]
0
0
Three months post-quit date
Query!
Secondary outcome [14]
0
0
Cigarette withdrawal
Query!
Assessment method [14]
0
0
The physical signs and symptoms associated with nicotine withdrawal over the last week, measured using the Mood and Physical Symptoms Scale (MPSS)
Query!
Timepoint [14]
0
0
Six months post-quit date
Query!
Secondary outcome [15]
0
0
Cigarettes per day
Query!
Assessment method [15]
0
0
Number of cigarettes smoked per day, if smoking
Query!
Timepoint [15]
0
0
One month post-quit date
Query!
Secondary outcome [16]
0
0
Cigarettes per day
Query!
Assessment method [16]
0
0
Number of cigarettes smoked per day, if smoking
Query!
Timepoint [16]
0
0
Three month post-quit date
Query!
Secondary outcome [17]
0
0
Cigarettes per day
Query!
Assessment method [17]
0
0
Number of cigarettes smoked per day, if smoking
Query!
Timepoint [17]
0
0
Six month post-quit date
Query!
Secondary outcome [18]
0
0
Cigarettes per day
Query!
Assessment method [18]
0
0
Number of cigarettes smoked per day, if smoking
Query!
Timepoint [18]
0
0
12 month post-quit date (in 2/3 of sample)
Query!
Secondary outcome [19]
0
0
Smoking satisfaction, if smoking
Query!
Assessment method [19]
0
0
Measured using the modified Cigarette Evaluation Questionnaire (mCEQ).
Query!
Timepoint [19]
0
0
One month post-quit date
Query!
Secondary outcome [20]
0
0
Smoking satisfaction, if smoking
Query!
Assessment method [20]
0
0
Measured using the modified Cigarette Evaluation Questionnaire (mCEQ).
Query!
Timepoint [20]
0
0
Three month post-quit date
Query!
Secondary outcome [21]
0
0
Smoking satisfaction, if smoking
Query!
Assessment method [21]
0
0
Measured using the modified Cigarette Evaluation Questionnaire (mCEQ).
Query!
Timepoint [21]
0
0
Six month post-quit date
Query!
Secondary outcome [22]
0
0
Health-related quality of life
Query!
Assessment method [22]
0
0
Measured using the New Zealand EQ-5D Tariff 2
Query!
Timepoint [22]
0
0
One month post-quit date
Query!
Secondary outcome [23]
0
0
Health-related quality of life
Query!
Assessment method [23]
0
0
Measured using the New Zealand EQ-5D Tariff 2
Query!
Timepoint [23]
0
0
Three months post-quit date
Query!
Secondary outcome [24]
0
0
Health-related quality of life
Query!
Assessment method [24]
0
0
Measured using the New Zealand EQ-5D Tariff 2
Query!
Timepoint [24]
0
0
Six months post-quit date
Query!
Secondary outcome [25]
0
0
Acceptability of allocated treatment
Query!
Assessment method [25]
0
0
Participants will be asked for their views on the use of their allocated medication as a cessation aid (i.e. whether they would recommend the treatment to another smoker and the things they liked or disliked about using the product).
Query!
Timepoint [25]
0
0
One month post-quit date
Query!
Secondary outcome [26]
0
0
Acceptability of allocated treatment
Query!
Assessment method [26]
0
0
Participants will be asked for their views on the use of their allocated medication as a cessation aid (i.e. whether they would recommend the treatment to another smoker and the things they liked or disliked about using the product).
Query!
Timepoint [26]
0
0
Three months post-quit date
Query!
Secondary outcome [27]
0
0
Use of other methods of cessation
Query!
Assessment method [27]
0
0
Participants will be asked about their use of other methods of cessation, such as NRT, Zyban, clonidine, nortriptyline, e-cigarettes, acupuncture etc.
Query!
Timepoint [27]
0
0
One month post-quit date
Query!
Secondary outcome [28]
0
0
Use of other methods of cessation
Query!
Assessment method [28]
0
0
Participants will be asked about their use of other methods of cessation, such as NRT, Zyban, clonidine, nortriptyline, e-cigarettes, acupuncture etc.
Query!
Timepoint [28]
0
0
Three months post-quit date
Query!
Secondary outcome [29]
0
0
Use of other methods of cessation
Query!
Assessment method [29]
0
0
Participants will be asked about their use of other methods of cessation, such as NRT, Zyban, clonidine, nortriptyline, e-cigarettes, acupuncture etc.
Query!
Timepoint [29]
0
0
Six months post-quit date
Query!
Secondary outcome [30]
0
0
Medication compliance
Query!
Assessment method [30]
0
0
Self-reported pill count, early stopping of allocated medication and reasons why.
Query!
Timepoint [30]
0
0
One month post-quit date
Query!
Secondary outcome [31]
0
0
Medication compliance
Query!
Assessment method [31]
0
0
Self-reported pill count, early stopping of allocated medication and reasons why.
Query!
Timepoint [31]
0
0
Three months post-quit date
Query!
Secondary outcome [32]
0
0
Adverse events
Query!
Assessment method [32]
0
0
Any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not it is considered related to the product.
Query!
Timepoint [32]
0
0
One month post-quit date
Query!
Secondary outcome [33]
0
0
Adverse events
Query!
Assessment method [33]
0
0
Any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not it is considered related to the product.
Query!
Timepoint [33]
0
0
Three month post-quit date
Query!
Secondary outcome [34]
0
0
Adverse events
Query!
Assessment method [34]
0
0
Any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not it is considered related to the product.
Query!
Timepoint [34]
0
0
Six month post-quit date
Query!
Secondary outcome [35]
0
0
Adverse events
Query!
Assessment method [35]
0
0
Any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not it is considered related to the product.
Query!
Timepoint [35]
0
0
12 month post-quit date (in 2/3 of sample)
Query!
Eligibility
Key inclusion criteria
* daily tobacco smokers
* self-identify as Maori (indigenous New Zealander) or whanau (family) of Maori
* want to stop smoking in the next two weeks
* are at least 18 years of age
* are able to provide verbal consent
* reside in the Lakes District Health Board, Eastern Bay of Plenty or Tokoroa region at the time of enrolment
* have daily access to a mobile phone with text capability and/or email and access to the internet via computer or smartphone
* are eligible for subsidised varenicline under special authority conditions
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
* are pregnant or breastfeeding
* are current users of other smoking cessation therapies (e.g. nicotine replacement therapy [NRT], buproprion [Zyban], clonidine, nortriptyline, e-cigarettes)
* are enrolled in another smoking cessation programme or another smoking cessation study
* have a contraindication for cytisine or varenicline
* have used varenicline or cytisine in the past 12 months
* have another person in their household involved in the trial
* have moderate or severe renal impairment,
* are being treated for active or latent TB
* have been treated for a heart attack, stroke, or severe angina within the last two weeks
* have uncontrolled high blood pressure (> 150 mmHg systolic, > 100 mmHg diastolic)
* have a history of seizures
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
18/09/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
10/10/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
679
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
New Zealand
Query!
State/province [1]
0
0
North Island
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
University of Auckland, New Zealand
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Lakes District Health Board
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Other
Query!
Name [2]
0
0
Brunel University
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
To evaluate the effectiveness, safety, and cost-effectiveness of cytisine plus behavioural support compared to varenicline plus behavioural support for smoking cessation, in indigenous Maori (or family of Maori) who smoke and are motivated to quit.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02957786
Query!
Trial related presentations / publications
Walker N, Smith B, Barnes J, Verbiest M, Kurdziel T, Parag V, Pokhrel S, Bullen C. Cytisine versus varenicline for smoking cessation for Maori (the indigenous people of New Zealand) and their extended family: protocol for a randomized non-inferiority trial. Addiction. 2019 Feb;114(2):344-352. doi: 10.1111/add.14449. Epub 2018 Nov 9. Walker N, Smith B, Barnes J, Verbiest M, Parag V, Pokhrel S, Wharakura MK, Lees T, Cubillos Gutierrez H, Jones B, Bullen C. Cytisine versus varenicline for smoking cessation in New Zealand indigenous Maori: a randomized controlled trial. Addiction. 2021 Oct;116(10):2847-2858. doi: 10.1111/add.15489. Epub 2021 May 4.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Natalie Walker, PhD
Query!
Address
0
0
University of Auckland, New Zealand
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
IPD analysis planned - details of plan not yet finalized
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Walker N, Smith B, Barnes J, Verbiest M, Parag V, ...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT02957786