Smoking cessation trials in primary care
Mike Bradburn with Michael Murphy, Mark Drury, Robert Walton, Karen Brown, Elaine Johnstone, Marcus Munafò, Tim Lancaster, Patricia Yudkin, Ed Piele, Christina Davies, Alastair Gray (Oxford), Paul Aveyard, Sue Wilson (Birmingham)
The use of nicotine replacement therapy (NRT) to assist attempts to stop smoking has become widespread, and a substantial body of evidence backs its effectiveness. However, questions remain as to how it may best be delivered to those attempting to stop smoking, and whether it is appropriate for certain types of smoker. The four trials proposed here will attempt to address some of these questions.
These trials will also investigate other smoking-related issues. Blood samples will be taken to enable genotyping and the possible identification of candidate genes that may predispose to an increased or reduced response to NRT. Cotinine will be measured by both blood and saliva sample for all patients in order to see how well these two commonly used methods agree. Finally, patients will be asked to complete questionnaires (including the Fagerstrom test for nicotine dependence and Eysenck personality), with the intention to assess whether personality is related to genotype and successful quit attempt.
Patch in Practice
The present trial focuses on the impact of counselling given to smokers in their attempts to quit. The study will be carried out in general practices, where smokers will be identified from patient notes. Participants will be randomised to receive one of two levels of counselling (either minimal or moderate) and all will be assisted by NRT patch. The study will therefore provide a guide as to whether the sort of support that may feasibly be offered in a general practice setting can benefit those who wish to cease smoking.
Patch Plus
This is a three-arm trial in which NRT will be delivered in one of three manners: NRT patch alone, NRT patch in conjunction NRT spray, and NRT patch in conjunction with NRT gum. The latter two deliveries may be advantageous in that they allow the smoker to vary their nicotine intake in a way that mimics the manner in which smoking changes it. The specific hypothesis is to test whether these improve quit rates and, if so, whether one seems preferable to the other. The study will be carried out in general practices, where smokers will be identified from patient notes.
RESCINDING (Realising Enhanced Smoking Cessation in Diseased INdividuals: individual effects of Genotype)
The use of NRT in smokers who are deemed “high risk” (for instance those who have ischaemic heart disease) is controversial, as there is concern (although little evidence) that NRT may be contra-indicated in this instance. It would be especially informative to know whether NRT could benefit these smokers, as it is precisely these who are at the highest risk of smoking related death and who may therefore benefit most from NRT. The present trial will identify high risk smokers from general practice notes, and ask people to agree to be randomised either to NRT or placebo patch over a ten week period. The trial seeks to confirm the effectiveness of NRT assisted interventions in this population, and to demonstrate equivalence of adverse events in the two arms of the trial over one year.
NRT and Nortriptyline
Nortriptyline, an older tricyclic antidepressant, has been shown to aid smoking cessation attempts and is therefore sometimes prescribed as an alternative to NRT. This trial explores the possibility that the two may work together to offer benefit additional to that seen from NRT alone. Smokers in NHS smoking cessation clinics will be recruited and randomised to receive NRT patch with either nortriptyline or placebo, with the proportion of successful attempts at smoking cessation to be compared.
