Preloading Trial

• Research type

  Research Study

• Full title

  An open label pragmatic randomised controlled trial of nicotine patch preloading for smoking cessation.

• IRAS ID

  89483

• Contact name

  Paul Aveyard

• Sponsor organisation

  University of Birmingham

• Eudract number

  2011-005134-19

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The trial is an open label pragmatic randomised controlled trial of nicotine preloading for smoking cessation. This will examine the safety, relative effectiveness and cost effectiveness of nicotine patch worn for 4 weeks prior to quitting in smokers plus standard NHS treatment for tobacco dependence versus standard treatment only. Participants at least 18 years old will be recruited via GP surgeries or NHS Stop Smoking Services, and those who consent will be randomised into one or two treatment groups. 1. intervention (participants given 4 weeks NRT prior to quit day). 2. control ?? no NRT administered prior to quit day and usual NHS treatment/advice thereafter. Participants will be assessed at the time of enrolment (baseline), 1 week later and the 1 week following their quit day, then at 6 months and 12 months, where those who report to be abstinent will be invited to clinic for carbon monoxide (CO ?? a standard measure of tobacco smoke exposure) to biologically confirm abstinence and weight measurements. Data relating to smoking behaviour will be collected at some of these assessments. The trial will be conducted in the West Midlands, Nottingham, Bristol and London.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  12/EM/0014

• Date of REC Opinion

  31 Jan 2012

• REC opinion

  Further Information Favourable Opinion