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Cytisine Versus Varenicline for Smoking Cessation (RAUORA)

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ClinicalTrials.gov Identifier: NCT02957786
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : October 16, 2018
Sponsor:
Collaborators:
Lakes District Health Board
Brunel University
Information provided by (Responsible Party):
Natalie Walker, University of Auckland, New Zealand

Tracking Information
First Submitted Date  ICMJE October 27, 2016
First Posted Date  ICMJE November 8, 2016
Last Update Posted Date October 16, 2018
Actual Study Start Date  ICMJE September 18, 2017
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2016)
Continuous abstinence from smoking [ Time Frame: Six months post-quit date ]
Self-report of smoking not more than five cigarettes from the quit date, supported by biochemical validation using a carbon monoxide (CO) expired breath
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02957786 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2017)
  • Continuous abstinence from smoking [ Time Frame: One month post-quit date ]
    Self-report of smoking not more than five cigarettes from the quit date
  • Continuous abstinence from smoking [ Time Frame: Three months post-quit date ]
    Self-report of smoking not more than five cigarettes from the quit date
  • Continuous abstinence from smoking [ Time Frame: 12 months post-quit date (in 2/3 of sample) ]
    Self-report of smoking not more than five cigarettes from the quit date, supported by biochemical validation using a carbon monoxide (CO) expired breath
  • 7-day point prevalence abstinence from smoking [ Time Frame: One month post-quit date ]
    Self-report of having smoked no cigarettes (not even a puff) in the past seven days.
  • 7-day point prevalence abstinence from smoking [ Time Frame: Three month post-quit date ]
    Self-report of having smoked no cigarettes (not even a puff) in the past seven days.
  • 7-day point prevalence abstinence from smoking [ Time Frame: Six month post-quit date ]
    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.
  • 7-day point prevalence abstinence from smoking [ Time Frame: 12 month post-quit date (in 2/3 of sample) ]
    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.
  • Time to relapse back to smoking [ Time Frame: One month post-quit date ]
    Defined as return to daily smoking.
  • Time to relapse back to smoking [ Time Frame: Three month post-quit date ]
    Defined as return to daily smoking.
  • Time to relapse back to smoking [ Time Frame: Six month post-quit date ]
    Defined as return to daily smoking.
  • Time to relapse back to smoking [ Time Frame: 12 month post-quit date (in 2/3 of sample) ]
    Defined as return to daily smoking.
  • Cigarette withdrawal [ Time Frame: One month post-quit date ]
    The physical signs and symptoms associated with nicotine withdrawal over the last week, measured using the Mood and Physical Symptoms Scale (MPSS)
  • Cigarette withdrawal [ Time Frame: Three months post-quit date ]
    The physical signs and symptoms associated with nicotine withdrawal over the last week, measured using the Mood and Physical Symptoms Scale (MPSS)
  • Cigarette withdrawal [ Time Frame: Six months post-quit date ]
    The physical signs and symptoms associated with nicotine withdrawal over the last week, measured using the Mood and Physical Symptoms Scale (MPSS)
  • Cigarettes per day [ Time Frame: One month post-quit date ]
    Number of cigarettes smoked per day, if smoking
  • Cigarettes per day [ Time Frame: Three month post-quit date ]
    Number of cigarettes smoked per day, if smoking
  • Cigarettes per day [ Time Frame: Six month post-quit date ]
    Number of cigarettes smoked per day, if smoking
  • Cigarettes per day [ Time Frame: 12 month post-quit date (in 2/3 of sample) ]
    Number of cigarettes smoked per day, if smoking
  • Smoking satisfaction, if smoking [ Time Frame: One month post-quit date ]
    Measured using the modified Cigarette Evaluation Questionnaire (mCEQ).
  • Smoking satisfaction, if smoking [ Time Frame: Three month post-quit date ]
    Measured using the modified Cigarette Evaluation Questionnaire (mCEQ).
  • Smoking satisfaction, if smoking [ Time Frame: Six month post-quit date ]
    Measured using the modified Cigarette Evaluation Questionnaire (mCEQ).
  • Health-related quality of life [ Time Frame: One month post-quit date ]
    Measured using the New Zealand EQ-5D Tariff 2
  • Health-related quality of life [ Time Frame: Three months post-quit date ]
    Measured using the New Zealand EQ-5D Tariff 2
  • Health-related quality of life [ Time Frame: Six months post-quit date ]
    Measured using the New Zealand EQ-5D Tariff 2
  • Acceptability of allocated treatment [ Time Frame: One month post-quit date ]
    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).
  • Acceptability of allocated treatment [ Time Frame: Three months post-quit date ]
    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).
  • Use of other methods of cessation [ Time Frame: One month post-quit date ]
    Participants will be asked about their use of other methods of cessation, such as NRT, Zyban, clonidine, nortriptyline, e-cigarettes, acupuncture etc.
  • Use of other methods of cessation [ Time Frame: Three months post-quit date ]
    Participants will be asked about their use of other methods of cessation, such as NRT, Zyban, clonidine, nortriptyline, e-cigarettes, acupuncture etc.
  • Use of other methods of cessation [ Time Frame: Six months post-quit date ]
    Participants will be asked about their use of other methods of cessation, such as NRT, Zyban, clonidine, nortriptyline, e-cigarettes, acupuncture etc.
  • Medication compliance [ Time Frame: One month post-quit date ]
    Self-reported pill count, early stopping of allocated medication and reasons why.
  • Medication compliance [ Time Frame: Three months post-quit date ]
    Self-reported pill count, early stopping of allocated medication and reasons why.
  • Adverse events [ Time Frame: One month post-quit date ]
    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.
  • Adverse events [ Time Frame: Three month post-quit date ]
    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.
  • Adverse events [ Time Frame: Six month post-quit date ]
    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.
  • Adverse events [ Time Frame: 12 month post-quit date (in 2/3 of sample) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2016)
  • Continuous abstinence from smoking [ Time Frame: One month post-quit date ]
    Self-report of smoking not more than five cigarettes from the quit date
  • Continuous abstinence from smoking [ Time Frame: Three months post-quit date ]
    Self-report of smoking not more than five cigarettes from the quit date
  • Continuous abstinence from smoking [ Time Frame: 12 months post-quit date (in 2/3 of sample) ]
    Self-report of smoking not more than five cigarettes from the quit date, supported by biochemical validation using a carbon monoxide (CO) expired breath
  • 7-day point prevalence abstinence from smoking [ Time Frame: One month post-quit date ]
    Self-report of having smoked no cigarettes (not even a puff) in the past seven days.
  • 7-day point prevalence abstinence from smoking [ Time Frame: Three month post-quit date ]
    Self-report of having smoked no cigarettes (not even a puff) in the past seven days.
  • 7-day point prevalence abstinence from smoking [ Time Frame: Six month post-quit date ]
    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.
  • 7-day point prevalence abstinence from smoking [ Time Frame: 12 month post-quit date (in 2/3 of sample) ]
    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.
  • Time to relapse back to smoking [ Time Frame: One month post-quit date ]
    Defined as return to daily smoking.
  • Time to relapse back to smoking [ Time Frame: Three month post-quit date ]
    Defined as return to daily smoking.
  • Time to relapse back to smoking [ Time Frame: Six month post-quit date ]
    Defined as return to daily smoking.
  • Time to relapse back to smoking [ Time Frame: 12 month post-quit date (in 2/3 of sample) ]
    Defined as return to daily smoking.
  • Cigarette withdrawal [ Time Frame: Asked on the participant's nominated Quit smoking date (5 days after treatment started) ]
    The physical signs and symptoms associated with nicotine withdrawal over the last week, measured using the Mood and Physical Symptoms Scale (MPSS)
  • Cigarette withdrawal [ Time Frame: One month post-quit date ]
    The physical signs and symptoms associated with nicotine withdrawal over the last week, measured using the Mood and Physical Symptoms Scale (MPSS)
  • Cigarette withdrawal [ Time Frame: Three months post-quit date ]
    The physical signs and symptoms associated with nicotine withdrawal over the last week, measured using the Mood and Physical Symptoms Scale (MPSS)
  • Cigarette withdrawal [ Time Frame: Six months post-quit date ]
    The physical signs and symptoms associated with nicotine withdrawal over the last week, measured using the Mood and Physical Symptoms Scale (MPSS)
  • Cigarettes per day [ Time Frame: Asked on the participant's nominated Quit smoking date (5 days after treatment started) ]
    Number of cigarettes smoked per day, if smoking
  • Cigarettes per day [ Time Frame: One month post-quit date ]
    Number of cigarettes smoked per day, if smoking
  • Cigarettes per day [ Time Frame: Three month post-quit date ]
    Number of cigarettes smoked per day, if smoking
  • Cigarettes per day [ Time Frame: Six month post-quit date ]
    Number of cigarettes smoked per day, if smoking
  • Cigarettes per day [ Time Frame: 12 month post-quit date (in 2/3 of sample) ]
    Number of cigarettes smoked per day, if smoking
  • Smoking satisfaction, if smoking [ Time Frame: Asked on the participant's nominated Quit smoking date (5 days after treatment started) ]
    Measured using the modified Cigarette Evaluation Questionnaire (mCEQ).
  • Smoking satisfaction, if smoking [ Time Frame: One month post-quit date ]
    Measured using the modified Cigarette Evaluation Questionnaire (mCEQ).
  • Smoking satisfaction, if smoking [ Time Frame: Three month post-quit date ]
    Measured using the modified Cigarette Evaluation Questionnaire (mCEQ).
  • Smoking satisfaction, if smoking [ Time Frame: Six month post-quit date ]
    Measured using the modified Cigarette Evaluation Questionnaire (mCEQ).
  • Health-related quality of life [ Time Frame: Asked on the participant's nominated Quit smoking date (5 days after treatment started) ]
    Measured using the New Zealand EQ-5D Tariff 2
  • Health-related quality of life [ Time Frame: One month post-quit date ]
    Measured using the New Zealand EQ-5D Tariff 2
  • Health-related quality of life [ Time Frame: Three months post-quit date ]
    Measured using the New Zealand EQ-5D Tariff 2
  • Health-related quality of life [ Time Frame: Six months post-quit date ]
    Measured using the New Zealand EQ-5D Tariff 2
  • Acceptability of allocated treatment [ Time Frame: Asked on the participant's nominated Quit smoking date (5 days after treatment started) ]
    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).
  • Acceptability of allocated treatment [ Time Frame: One month post-quit date ]
    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).
  • Acceptability of allocated treatment [ Time Frame: Three months post-quit date ]
    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).
  • Use of other methods of cessation [ Time Frame: Asked on the participant's nominated Quit smoking date (5 days after treatment started) ]
    Participants will be asked about their use of other methods of cessation, such as NRT, Zyban, clonidine, nortriptyline, e-cigarettes, acupuncture etc.
  • Use of other methods of cessation [ Time Frame: One month post-quit date ]
    Participants will be asked about their use of other methods of cessation, such as NRT, Zyban, clonidine, nortriptyline, e-cigarettes, acupuncture etc.
  • Use of other methods of cessation [ Time Frame: Three months post-quit date ]
    Participants will be asked about their use of other methods of cessation, such as NRT, Zyban, clonidine, nortriptyline, e-cigarettes, acupuncture etc.
  • Use of other methods of cessation [ Time Frame: Six months post-quit date ]
    Participants will be asked about their use of other methods of cessation, such as NRT, Zyban, clonidine, nortriptyline, e-cigarettes, acupuncture etc.
  • Medication adherence [ Time Frame: Asked on the participant's nominated Quit smoking date (5 days after treatment started) ]
    Whether participant redeemed their allocoted script
  • Medication compliance [ Time Frame: Asked on the participant's nominated Quit smoking date (5 days after treatment started) ]
    Self-reported pill count, early stopping of allocated medication and reasons why.
  • Medication compliance [ Time Frame: One month post-quit date ]
    Self-reported pill count, early stopping of allocated medication and reasons why.
  • Medication compliance [ Time Frame: Three months post-quit date ]
    Self-reported pill count, early stopping of allocated medication and reasons why.
  • Adverse events [ Time Frame: Asked on the participant's nominated Quit smoking date (5 days after treatment started) ]
    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.
  • Adverse events [ Time Frame: One month post-quit date ]
    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.
  • Adverse events [ Time Frame: Three month post-quit date ]
    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.
  • Adverse events [ Time Frame: Six month post-quit date ]
    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.
  • Adverse events [ Time Frame: 12 month post-quit date (in 2/3 of sample) ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cytisine Versus Varenicline for Smoking Cessation
Official Title  ICMJE RAUORA: Cytisine Versus Varenicline for Smoking Cessation
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 Māori (or family of Māori) who smoke and are motivated to quit.
Detailed Description Cytisine, a natural product, found in plants such as the Golden Rain and New Zealand Kowhai, partially blocks the effects of nicotine on the brain. Cytisine has been used as a smoking cessation treatment in several Central and Eastern European countries since the 1960s, is inexpensive compared to other cessation medications and has few known side effects. New Zealand research has shown cytisine to be more effective than nicotine replacement therapy at helping people quit smoking. Using a clinical trial design (N=2140) the investigators plan to investigate whether cytisine is at least as good as varenicline (the most effective, but most expensive, smoking cessation medication currently available in New Zealand) for helping Māori/family of Māori who smoke, to quit.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • Drug: Cytisine
    Cytisine tablets
    Other Name: Tabex
  • Behavioral: Behavioural support
    Withdrawal-orientated cessation support
  • Drug: Varenicline
    Varenicline tablets
    Other Name: Champix
Study Arms  ICMJE
  • 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).

    Interventions:
    • Drug: Cytisine
    • Behavioral: Behavioural support
  • 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).

    Interventions:
    • Behavioral: Behavioural support
    • Drug: Varenicline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 7, 2016)
2140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • daily tobacco smokers
  • self-identify as Māori (indigenous New Zealander) or whānau (family) of Māori
  • 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 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

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Natalie Walker, PhD 64 9 373 7999 n.walker@auckland.ac.nz
Contact: Chris Bullen, PhD, MBChB 64 9 373 7999 c.bullen@auckland.ac.nz
Listed Location Countries  ICMJE New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02957786
Other Study ID Numbers  ICMJE UTN: U1111-1187-2838
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: IPD analysis planned - details of plan not yet finalized
Responsible Party Natalie Walker, University of Auckland, New Zealand
Study Sponsor  ICMJE University of Auckland, New Zealand
Collaborators  ICMJE
  • Lakes District Health Board
  • Brunel University
Investigators  ICMJE
Principal Investigator: Natalie Walker, PhD University of Auckland, New Zealand
PRS Account University of Auckland, New Zealand
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP