The effect of Tabex (cytisine) on success of attempts to stop smoking

Promoting smoking cessation is probably the single most important goal in reducing cancer. There are several drugs that can help, and psychological support is also effective. There is an opportunity to evaluate a drug (Tabex) that has been in use in Eastern Europe for many years, is generic and cheap to manufacture ? so much so that it costs less than one fifth of current medications. This would be of considerable benefit to UK smokers, the NHS and perhaps more importantly to low income smokers overseas. The proposed rigorous trial would be conducted in Poland and would represent exceptional value for money.

The findings will be taken forward through discussion with the MHRA and other relevant regulatory bodies to establish a basis for licensing. The results will also be dissemintated through appropriate press offices once a paper has been punlished in an appropriate peer review journal.

This is a placebo-controlled RCT of Tabex (cytisine) as an aid to smoking cessation. Tabex currently has a licence as a stop smoking medication in some countries in Eastern Europe and has undergone Phase I, Phase II studies and clinical trials. However, the clinical evidence is not sufficient to permit firm conclusions to be made about efficacy or for a licence to be granted in countires such as the UK or US. A recent uncontrolled study in Poland found 12-month continuous abstinence rates, verified by expired air CO, of 18% with minimal behavioural support. This compares favourably with success rates using nicotine replacement therapy. Tabex is very inexpensive and offers the prospect of a treatment costing a small fraction of that currently available. 720 smokers of 10 or more cigarettes per day who are not contra-indicated for the medication would receive Tabex or matching placebo. The primary outcome measure would be 6-months? continuous abstinence verified by expired-air CO.