Rapid Reduction Trial v1

• Research type

  Research Study

• Full title

  Rapid reduction versus abrupt quitting for smokers who want to stop soon: a randomised controlled non-inferiority trial.

• IRAS ID

  10840

• Sponsor organisation

  University of Birmingham

• Eudract number

  2008-006433-28

• ISRCTN Number

  ISRCTN22526020

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Standard stop smoking programmes do not allow gradual reduction of cigarettes smoked, though many smokers who do not use treatment might do so if reduction was offered. Reduction may also offer a new method of quitting for smokers that have failed to quit in other ways, resulting in more people stopping smoking. There are currently too few trials to be clear whether gradual reduction or abrupt stopping is more effective. If reduction programmes were offered, they would attract people who would have otherwise stopped by normal abrupt quit methods, so we need to be sure that such people are not disadvantaged. Therefore we are conducting a randomised controlled non-inferiority trial comparing rapid reduction and abrupt quitting techniques for smokers who want to stop soon, funded by the British Heart Foundation. Participants will be recruited through their GPs and through the NHS Stop Smoking Services. They will then be randomised 1:1 to either a rapid reduction treatment arm or the abrupt quitting arm of the trial. The Participants in the rapid reduction arm will reduce their smoking over 2 weeks using one of four methods, whilst using nicotine replacement therapy (NRT), and will then stop completely on an agreed quit day. Participants abruptly quitting will also use NRT for 2 weeks prior to quitting, to balance the nicotine intake in both areas, but will not cut down and will stop abruptly on an agreed quit day. The outcome of interest will be abstinence from cigarette smoking at four week, 8 week and 6 month follow-up. Participants will be asked to keep a diary of their smoking and NRT use in both areas for both weeks pre quit and for a week post quit.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  08/H0408/213

• Date of REC Opinion

  20 Jan 2009

• REC opinion

  Further Information Favourable Opinion