A3051139 - Smoking Cessation

• Research type

  Research Study

• Full title

  A PHASE 4 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF RETREATMENT WITH VARENICLINE IN SUBJECTS WHO ARE CURRENTLY SMOKING, AND WHO HAVE PREVIOUSLY TAKEN VARENICLINE.

• IRAS ID

  71879

• Contact name

  Mark Caulfield

• Sponsor organisation

  Pfizer Inc.

• Eudract number

  2010-021789-31

• Research summary

  Smoking is considered a chronic, relapsing medical condition because of the addictive nature of nicotine. The strength of the addiction to nicotine resulting from cigarette smoking is such that most smokers return to smoking, even when anti-stop smoking agents have been used. This study is being conducted to assesses the safety and efficacy of varenicline (an approved treatment) as an aid to smoking cessation in subjects who are currently smoking (for at least 4 weeks), and who have previously taken varenicline for a minimum duration of 2 weeks, to support a smoking cessation attempt (at least 3 months previously.) In total, globally 490 subjects and approximately 30 investigational sites will be required for this study. Subjects will enter an initial screening period (3-10 days) and those subjects meeting the randomization (eligibility) criteria will then enter the 12 week treatment period to receive varenicline or matching placebo (treatment allocation will be chance, like an flip of a coin and neither the investigator nor the subject will know who is receiving varenicline and who is receiving placebo i.e. double blinding). After completion of the active treatment phase, subjects will enter the non-treatment follow-up period for a further 40 weeks, to week 52 of the study.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  11/YH/0044

• Date of REC Opinion

  21 Apr 2011

• REC opinion

  Further Information Favourable Opinion