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Completed

NCT Number: NCT02957786

Cytisine Versus Varenicline for Smoking Cessation

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Institute for Health Innovation, University of Auckland

Auckland, North Island, 1072, New Zealand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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, 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

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

Treatment and study plan

cytisine

Drug

Cytisine tablets

Other names: Tabex

Behavioural support

Behavioral

Withdrawal-orientated cessation support

Varenicline

Drug

Varenicline tablets

Other names: Champix

Primary outcomes

  1. 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

Secondary outcomes

  1. Continuous abstinence from smoking

    Time frame: One month post-quit date

    Self-report of smoking not more than five cigarettes from the quit date

  2. Continuous abstinence from smoking

    Time frame: Three months post-quit date

    Self-report of smoking not more than five cigarettes from the quit date

  3. 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

  4. 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.

  5. 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.

  6. 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. 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.

  8. Time to relapse back to smoking

    Time frame: One month post-quit date

    Defined as return to daily smoking.

  9. Time to relapse back to smoking

    Time frame: Three month post-quit date

    Defined as return to daily smoking.

  10. Time to relapse back to smoking

    Time frame: Six month post-quit date

    Defined as return to daily smoking.

  11. Time to relapse back to smoking

    Time frame: 12 month post-quit date (in 2/3 of sample)

    Defined as return to daily smoking.

  12. 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)

  13. 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)

  14. 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)

  15. Cigarettes per day

    Time frame: One month post-quit date

    Number of cigarettes smoked per day, if smoking

  16. Cigarettes per day

    Time frame: Three month post-quit date

    Number of cigarettes smoked per day, if smoking

  17. Cigarettes per day

    Time frame: Six month post-quit date

    Number of cigarettes smoked per day, if smoking

  18. Cigarettes per day

    Time frame: 12 month post-quit date (in 2/3 of sample)

    Number of cigarettes smoked per day, if smoking

  19. Smoking satisfaction, if smoking

    Time frame: One month post-quit date

    Measured using the modified Cigarette Evaluation Questionnaire (mCEQ).

  20. Smoking satisfaction, if smoking

    Time frame: Three month post-quit date

    Measured using the modified Cigarette Evaluation Questionnaire (mCEQ).

  21. Smoking satisfaction, if smoking

    Time frame: Six month post-quit date

    Measured using the modified Cigarette Evaluation Questionnaire (mCEQ).

  22. Health-related quality of life

    Time frame: One month post-quit date

    Measured using the New Zealand EQ-5D Tariff 2

  23. Health-related quality of life

    Time frame: Three months post-quit date

    Measured using the New Zealand EQ-5D Tariff 2

  24. Health-related quality of life

    Time frame: Six months post-quit date

    Measured using the New Zealand EQ-5D Tariff 2

  25. 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).

  26. 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).

  27. 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.

  28. 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.

  29. 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.

  30. Medication compliance

    Time frame: One month post-quit date

    Self-reported pill count, early stopping of allocated medication and reasons why.

  31. Medication compliance

    Time frame: Three months post-quit date

    Self-reported pill count, early stopping of allocated medication and reasons why.

  32. 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.

  33. 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.

  34. 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.

  35. 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.

Sponsors and collaborators

Lead sponsor

University of Auckland, New Zealand

Other

Collaborators

  • Brunel University
  • Lakes District Health Board

Registry information

Official study title

RAUORA: Cytisine Versus Varenicline for Smoking Cessation

Acronym: RAUORA

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 8, 2016
Registry last updated
Aug 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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