Cytisine Versus Varenicline for Smoking Cessation

Smoking Cessation Clinical Trial

— RAUORA  

Official title:

RAUORA: Cytisine Versus Varenicline for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02957786
• Other study ID #: UTN: U1111-1187-2838
• Status: Completed
• Phase: Phase 3
• Start date: September 18, 2017
• Est. completion date: October 10, 2019

Study information

• Verified date: August 2021
• Source: University of Auckland, New Zealand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 679
• Est. completion date: October 10, 2019
• Est. primary completion date: October 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• Cytisine
Cytisine tablets

Behavioral:
• Behavioural support
Withdrawal-orientated cessation support

Drug:
• Varenicline
Varenicline tablets

Locations

Country	Name	City	State
New Zealand	National Institute for Health Innovation, University of Auckland	Auckland	North Island

Sponsors (3)

Lead Sponsor	Collaborator
University of Auckland, New Zealand	Brunel University, Lakes District Health Board

Country where clinical trial is conducted

New Zealand, 

References & Publications (2)

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. — View Citation

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 M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continuous abstinence from smoking	Self-report of smoking not more than five cigarettes from the quit date, supported by biochemical validation using a carbon monoxide (CO) expired breath	Six months post-quit date
Secondary	Continuous abstinence from smoking	Self-report of smoking not more than five cigarettes from the quit date	One month post-quit date
Secondary	Continuous abstinence from smoking	Self-report of smoking not more than five cigarettes from the quit date	Three months post-quit date
Secondary	Continuous abstinence from smoking	Self-report of smoking not more than five cigarettes from the quit date, supported by biochemical validation using a carbon monoxide (CO) expired breath	12 months post-quit date (in 2/3 of sample)
Secondary	7-day point prevalence abstinence from smoking	Self-report of having smoked no cigarettes (not even a puff) in the past seven days.	One month post-quit date
Secondary	7-day point prevalence abstinence from smoking	Self-report of having smoked no cigarettes (not even a puff) in the past seven days.	Three month post-quit date
Secondary	7-day point prevalence abstinence from smoking	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.	Six month post-quit date
Secondary	7-day point prevalence abstinence from smoking	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.	12 month post-quit date (in 2/3 of sample)
Secondary	Time to relapse back to smoking	Defined as return to daily smoking.	One month post-quit date
Secondary	Time to relapse back to smoking	Defined as return to daily smoking.	Three month post-quit date
Secondary	Time to relapse back to smoking	Defined as return to daily smoking.	Six month post-quit date
Secondary	Time to relapse back to smoking	Defined as return to daily smoking.	12 month post-quit date (in 2/3 of sample)
Secondary	Cigarette withdrawal	The physical signs and symptoms associated with nicotine withdrawal over the last week, measured using the Mood and Physical Symptoms Scale (MPSS)	One month post-quit date
Secondary	Cigarette withdrawal	The physical signs and symptoms associated with nicotine withdrawal over the last week, measured using the Mood and Physical Symptoms Scale (MPSS)	Three months post-quit date
Secondary	Cigarette withdrawal	The physical signs and symptoms associated with nicotine withdrawal over the last week, measured using the Mood and Physical Symptoms Scale (MPSS)	Six months post-quit date
Secondary	Cigarettes per day	Number of cigarettes smoked per day, if smoking	One month post-quit date
Secondary	Cigarettes per day	Number of cigarettes smoked per day, if smoking	Three month post-quit date
Secondary	Cigarettes per day	Number of cigarettes smoked per day, if smoking	Six month post-quit date
Secondary	Cigarettes per day	Number of cigarettes smoked per day, if smoking	12 month post-quit date (in 2/3 of sample)
Secondary	Smoking satisfaction, if smoking	Measured using the modified Cigarette Evaluation Questionnaire (mCEQ).	One month post-quit date
Secondary	Smoking satisfaction, if smoking	Measured using the modified Cigarette Evaluation Questionnaire (mCEQ).	Three month post-quit date
Secondary	Smoking satisfaction, if smoking	Measured using the modified Cigarette Evaluation Questionnaire (mCEQ).	Six month post-quit date
Secondary	Health-related quality of life	Measured using the New Zealand EQ-5D Tariff 2	One month post-quit date
Secondary	Health-related quality of life	Measured using the New Zealand EQ-5D Tariff 2	Three months post-quit date
Secondary	Health-related quality of life	Measured using the New Zealand EQ-5D Tariff 2	Six months post-quit date
Secondary	Acceptability of allocated treatment	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).	One month post-quit date
Secondary	Acceptability of allocated treatment	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).	Three months post-quit date
Secondary	Use of other methods of cessation	Participants will be asked about their use of other methods of cessation, such as NRT, Zyban, clonidine, nortriptyline, e-cigarettes, acupuncture etc.	One month post-quit date
Secondary	Use of other methods of cessation	Participants will be asked about their use of other methods of cessation, such as NRT, Zyban, clonidine, nortriptyline, e-cigarettes, acupuncture etc.	Three months post-quit date
Secondary	Use of other methods of cessation	Participants will be asked about their use of other methods of cessation, such as NRT, Zyban, clonidine, nortriptyline, e-cigarettes, acupuncture etc.	Six months post-quit date
Secondary	Medication compliance	Self-reported pill count, early stopping of allocated medication and reasons why.	One month post-quit date
Secondary	Medication compliance	Self-reported pill count, early stopping of allocated medication and reasons why.	Three months post-quit date
Secondary	Adverse events	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.	One month post-quit date
Secondary	Adverse events	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.	Three month post-quit date
Secondary	Adverse events	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.	Six month post-quit date
Secondary	Adverse events	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.	12 month post-quit date (in 2/3 of sample)