A3051075 Smoking Cessation Through Reduction Study
Research type
Research Study
Full title
A PHASE 4, MULTI-NATIONAL, RANDOMIZED, DOUBLE-BLIND,PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF VARENICLINE COMPARED TO PLACEBO FOR SMOKING CESSATION THROUGH REDUCTION
IRAS ID
86081
Contact name
Keir Lewis
Sponsor organisation
Pfizer Inc
Eudract number
2010-021788-33
Clinicaltrials.gov Identifier
Research summary
Smoking is considered a chronic, relapsing medical condition because of the addictive nature of nicotine, contained in cigarettes. The power of the addiction resulting from cigarette smoking is such that most smokers return to smoking, even when anti-stop smoking agents have been used. Many smokers wish to quit by slowly reducing the number of cigarettes smoked until they stop completely (known as ??Reduce to Quit??). A US-based People'survey reported that 42% of smokers said they wanted to quit smoking completely, of whom 44% preferred to use a reduce to quit method. A recent review group reported that reducing the number of cigarettes prior to quitting to suddenly quitting showed as good quit rates. This study is being conducted to look at the safety and effectiveness of an approved drug called Varenicline. The study will enrol patients who are not able to make an abrupt attempt at quitting but are willing to reduce their smoking with the end goal of quitting. Patients will enter an initial screening phase of 3-10 days and those that meet all the eligibility criteria will then enter the 24 week treatment phase to receive either Vareniciline or matching placebo. The patients will be randomised to receive Varenciline or placebo. Neither the investigator nor the patient will know which drug is received. In the first 12 weeks of the treatment patients will be encouraged to reduce the number of cigarettes smoked, whilst taking the assigned study medication. The next 12 weeks patients are expected to stop smoking, whilst still taking the assigned study medication. After completion of the 24 week treatment phase, subjects will enter the non-treatment follow-up period for a further 28 weeks, when they will complete the study. Patients will be in the study for approximately 52 weeks.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
11/EE/0481
Date of REC Opinion
2 Mar 2012
REC opinion
Further Information Favourable Opinion