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Trial record 5 of 9 for:    CYTISINE

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

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: Cytisine Behavioral: Behavioural support Drug: Varenicline Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: RAUORA: Cytisine Versus Varenicline for Smoking Cessation
Actual Study Start Date : September 18, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).

Drug: Cytisine
Cytisine tablets
Other Name: Tabex

Behavioral: Behavioural support
Withdrawal-orientated cessation 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).

Behavioral: Behavioural support
Withdrawal-orientated cessation support

Drug: Varenicline
Varenicline tablets
Other Name: Champix




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957786


Contacts
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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

Locations
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New Zealand
National Institute for Health Innovation, University of Auckland Recruiting
Auckland, North Island, New Zealand, 1072
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   
Principal Investigator: Natalie Walker, PhD         
Sub-Investigator: Chris Bullen, PhD;MBChB         
Sub-Investigator: Joanne Barnes, PhD         
Sub-Investigator: Barry Smith, PhD         
Sub-Investigator: Subhash Pokhrel, PhD         
Sub-Investigator: Varsha Parag, MSc (Hons)         
Sponsors and Collaborators
University of Auckland, New Zealand
Lakes District Health Board
Brunel University
Investigators
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Principal Investigator: Natalie Walker, PhD University of Auckland, New Zealand

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Responsible Party: Natalie Walker, Associate Professor, University of Auckland, New Zealand
ClinicalTrials.gov Identifier: NCT02957786     History of Changes
Other Study ID Numbers: UTN: U1111-1187-2838
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD analysis planned - details of plan not yet finalized

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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

Keywords provided by Natalie Walker, University of Auckland, New Zealand:
cytisine
varenicline
smoking cessation
indigenous

Additional relevant MeSH terms:
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Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs