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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
Scientific title
RAUORA: Cytisine Versus Varenicline for Smoking Cessation
Secondary ID [1] 0 0
UTN: U1111-1187-2838
Universal Trial Number (UTN)
Trial acronym
RAUORA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking Cessation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Continuous abstinence from smoking
Timepoint [1] 0 0
Six months post-quit date
Secondary outcome [1] 0 0
Continuous abstinence from smoking
Timepoint [1] 0 0
One month post-quit date
Secondary outcome [2] 0 0
Continuous abstinence from smoking
Timepoint [2] 0 0
Three months post-quit date
Secondary outcome [3] 0 0
Continuous abstinence from smoking
Timepoint [3] 0 0
12 months post-quit date (in 2/3 of sample)
Secondary outcome [4] 0 0
7-day point prevalence abstinence from smoking
Timepoint [4] 0 0
One month post-quit date
Secondary outcome [5] 0 0
7-day point prevalence abstinence from smoking
Timepoint [5] 0 0
Three month post-quit date
Secondary outcome [6] 0 0
7-day point prevalence abstinence from smoking
Timepoint [6] 0 0
Six month post-quit date
Secondary outcome [7] 0 0
7-day point prevalence abstinence from smoking
Timepoint [7] 0 0
12 month post-quit date (in 2/3 of sample)
Secondary outcome [8] 0 0
Time to relapse back to smoking
Timepoint [8] 0 0
One month post-quit date
Secondary outcome [9] 0 0
Time to relapse back to smoking
Timepoint [9] 0 0
Three month post-quit date
Secondary outcome [10] 0 0
Time to relapse back to smoking
Timepoint [10] 0 0
Six month post-quit date
Secondary outcome [11] 0 0
Time to relapse back to smoking
Timepoint [11] 0 0
12 month post-quit date (in 2/3 of sample)
Secondary outcome [12] 0 0
Cigarette withdrawal
Timepoint [12] 0 0
One month post-quit date
Secondary outcome [13] 0 0
Cigarette withdrawal
Timepoint [13] 0 0
Three months post-quit date
Secondary outcome [14] 0 0
Cigarette withdrawal
Timepoint [14] 0 0
Six months post-quit date
Secondary outcome [15] 0 0
Cigarettes per day
Timepoint [15] 0 0
One month post-quit date
Secondary outcome [16] 0 0
Cigarettes per day
Timepoint [16] 0 0
Three month post-quit date
Secondary outcome [17] 0 0
Cigarettes per day
Timepoint [17] 0 0
Six month post-quit date
Secondary outcome [18] 0 0
Cigarettes per day
Timepoint [18] 0 0
12 month post-quit date (in 2/3 of sample)
Secondary outcome [19] 0 0
Smoking satisfaction, if smoking
Timepoint [19] 0 0
One month post-quit date
Secondary outcome [20] 0 0
Smoking satisfaction, if smoking
Timepoint [20] 0 0
Three month post-quit date
Secondary outcome [21] 0 0
Smoking satisfaction, if smoking
Timepoint [21] 0 0
Six month post-quit date
Secondary outcome [22] 0 0
Health-related quality of life
Timepoint [22] 0 0
One month post-quit date
Secondary outcome [23] 0 0
Health-related quality of life
Timepoint [23] 0 0
Three months post-quit date
Secondary outcome [24] 0 0
Health-related quality of life
Timepoint [24] 0 0
Six months post-quit date
Secondary outcome [25] 0 0
Acceptability of allocated treatment
Timepoint [25] 0 0
One month post-quit date
Secondary outcome [26] 0 0
Acceptability of allocated treatment
Timepoint [26] 0 0
Three months post-quit date
Secondary outcome [27] 0 0
Use of other methods of cessation
Timepoint [27] 0 0
One month post-quit date
Secondary outcome [28] 0 0
Use of other methods of cessation
Timepoint [28] 0 0
Three months post-quit date
Secondary outcome [29] 0 0
Use of other methods of cessation
Timepoint [29] 0 0
Six months post-quit date
Secondary outcome [30] 0 0
Medication compliance
Timepoint [30] 0 0
One month post-quit date
Secondary outcome [31] 0 0
Medication compliance
Timepoint [31] 0 0
Three months post-quit date
Secondary outcome [32] 0 0
Adverse events
Timepoint [32] 0 0
One month post-quit date
Secondary outcome [33] 0 0
Adverse events
Timepoint [33] 0 0
Three month post-quit date
Secondary outcome [34] 0 0
Adverse events
Timepoint [34] 0 0
Six month post-quit date
Secondary outcome [35] 0 0
Adverse events
Timepoint [35] 0 0
12 month post-quit date (in 2/3 of sample)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/10/2019
Sample size
Target
Accrual to date
Final
679
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
North Island

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Lakes District Health Board
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Brunel University
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Natalie Walker, PhD
Address 0 0
University of Auckland, New Zealand
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD analysis planned - details of plan not yet finalized
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations 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