Smoking Cessation
Conditions
Keywords
cytisine, varenicline, smoking cessation, indigenous
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.
Interventions
DRUGCytisine
Cytisine tablets
BEHAVIORALBehavioural support
Withdrawal-orientated cessation support
DRUGVarenicline
Varenicline tablets
Sponsors
Lakes District Health Board
Brunel University
University of Auckland, New Zealand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 7-day point prevalence abstinence from smoking | One month post-quit date | Self-report of having smoked no cigarettes (not even a puff) in the past seven days. |
| Time to relapse back to smoking | One month post-quit date | Defined as return to daily smoking. |
| Cigarette withdrawal | 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) |
| Cigarettes per day | One month post-quit date | Number of cigarettes smoked per day, if smoking |
| Smoking satisfaction, if smoking | One month post-quit date | Measured using the modified Cigarette Evaluation Questionnaire (mCEQ). |
| Continuous abstinence from smoking | One month post-quit date | Self-report of smoking not more than five cigarettes from the quit date |
| Acceptability of allocated treatment | 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). |
| Use of other methods of cessation | 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. |
| Medication compliance | One month post-quit date | Self-reported pill count, early stopping of allocated medication and reasons why. |
| Adverse events | 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. |
| Health-related quality of life | One month post-quit date | Measured using the New Zealand EQ-5D Tariff 2 |
Countries
New Zealand
Outcome results
None listed