Cytisine Versus Varenicline for Smoking Cessation
- Conditions
- Smoking Cessation
- Interventions
- Registration Number
- NCT02957786
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 679
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cytisine plus behavioural support 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). Varenicline plus behavioural support 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). Varenicline plus behavioural support Varenicline 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). Cytisine plus behavioural support Cytisine 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).
- Primary Outcome Measures
Name Time Method Continuous abstinence from smoking 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
Name Time Method Medication compliance Three months post-quit date Self-reported pill count, early stopping of allocated medication and reasons why.
Continuous abstinence from smoking 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 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 12 month post-quit date (in 2/3 of sample) Defined as return to daily smoking.
Acceptability of allocated treatment 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).
Cigarette withdrawal 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 12 month post-quit date (in 2/3 of sample) Number of cigarettes smoked per day, if smoking
Smoking satisfaction, if smoking Six month post-quit date Measured using the modified Cigarette Evaluation Questionnaire (mCEQ).
Health-related quality of life Six months post-quit date Measured using the New Zealand EQ-5D Tariff 2
Use of other methods of cessation 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.
Adverse events 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.
Trial Locations
- Locations (1)
National Institute for Health Innovation, University of Auckland
🇳🇿Auckland, North Island, New Zealand