CASCAID Study: Cytisine as a smoking cessation aid
A single-blind randomised controlled non-inferiority clinical trial to evaluate the efficacy and safety of cytisine compared to usual care (21mg, 14mg, or 7mg nicotine patch, 4mg or 2mg nicotine gum or 2mg or 1mg nicotine lozenge nicotine replacement therapy (NRT) plus behavioural support) as a treatment for people who wish to stop smoking
Health Research Council NZ
1,310 participants
Mar 29, 2011
Interventional
Conditions
Summary
Cytisine is a medicine, derived from the Golden Rain Tree that partially blocks the effects of nicotine on the brain. Cytisine has been used as a smoking cessation treatment in several European countries since the 1960s, is inexpensive compared to other cessation medications and has few known side effects. Despite its long history of use there are few studies looking at whether cytisine actually works. Results from trials that have been undertaken suggest that taking cytisine almost doubles the chances of successfully quitting smoking, compared to a placebo. However, these studies were not conducted using modern research standards so their positive findings may not be valid. We propose to investigate the effectiveness of cytisine as a quit smoking aid and whether it is safe and acceptable to smokers.
Eligibility
Inclusion Criteria4
- they want to stop smoking,
- they are at least 18 years of age,
- they are able to provide verbal consent,
- they have access to a telephone.
Exclusion Criteria8
- they are pregnant or breastfeeding,
- they are current users of NRT products,
- they are current users of non-NRT smoking cessation therapies (e.g. buproprion [Zyban], clonidine, nortriptyline, or varenicline [Champix]),
- they are enrolled in another smoking cessation programme (e.g. Txt2Quit but concurrent referral to a face-to-face provider from Quitline is acceptable) or other cessation study (e.g. Fit2Quit),
- they have had a heart attack, stroke, or severe angina within the previous two weeks,
- they have uncontrolled high blood pressure (> 150 mmHg systolic, > 100 mmHg diastolic),
- they have phaeochromocytoma,
- they suffer from schizophrenia.
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Interventions
1. Tabex (Registered Trademark) oral tablet - 1.5 mg of cytisine per tablet (Sopharma) for 28 days. 2. Including 8 weeks of smoking cessation behavioural support supplied via Quitline New Zealand (NZ) (usually 3 telephone counselling calls over an 8 week period)
Locations(1)
View Full Details on ANZCTR
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ACTRN12610000590066