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    1 Comment for this article
    Was this varenicline trial blind?
    John R. Polito, JD | Director, WhyQuit.com
    Was this pre-quitting varenicline study blind as claimed? If one-third of the pre-quitting active group reduced smoking by greater than 50% prior to quitting day, do the authors suggest that this substantial reduction went unnoticed by participants? Rose et al's 2009 pre-quitting nicotine patch study reported that four times as many placebo patch users correctly determined their assignment as guessed wrong.1 I hypothesize that here, where participants averaged 2.7 prior quitting attempts, although profound in both groups, that failure of the blind was likely greater in the active than placebo group. The authors cite Mooney 2004 yet ignore the study's express warning that "the validity of...clinical trial results could be questioned" if future studies fail to make proper blinding assessments.2 Has there ever been a blinding integrity assessment in any varenicline study? If not, why?
    Blinding concerns become apparent when contrasting varenciline's 4-week 2009-10 UK NHS Stop Smoking Services quitting rate of 60%3 to both this study's 4-week placebo rate of 33% and its extended pre-quitting use rate of 49%. Why was regular treatment only half as effective? Considering that UK NHS Stop Smoking Services non-medication quitters also experienced a 49% 4-week quitting rate, at a point in time when all varenicline quitters had yet to attempt to stop using it and adjust to natural dopamine pathway stimulation, is it possible that supported/counseled cold turkey quitters would prevail long-term over varenicline? Why study longer pre-quitting use of varenicline when we don't yet know whether varenicline is more effective long-term than quitting cold turkey?
    Also, do the authors have any idea of the percentage of success attributable to varenicline and the percentage attributable to the twelve UK NHS Stop Smoking Service "weekly support sessions?" We're told that the vast majority of real-world varenicline users use it without any formal counseling or support. If true, why design yet another varenicline trial that fails to reveal varenicline's worth as a stand alone quitting aid?
    John R. Polito, JD Nicotine Cessation Educator
    1. Rose JE et al, Effectiveness of Extended-Duration Transdermal Nicotine Therapy: A Randomized Trial ANN INTERN MED (2010) 152(3): 144-151. 2. Mooney M, White T, Hatsukami D., The blind spot in the nicotine replacement therapy literature: assessment of the double-blind in clinical trials. Addict Behav. 2004;29(4):673-684. 3. NHS, The Information Centre, Statistics on NHS Stop Smoking Services: England, April 2009 - March 2010, Publication Date August 19, 2010, Table 4.4

    Conflict of Interest: None declared
    Original Investigation
    April 25, 2011

    Use of Varenicline for 4 Weeks Before Quitting Smoking: Decrease in Ad Lib Smoking and Increase in Smoking Cessation Rates

    Author Affiliations

    Author Affiliations: United Kingdom Centre for Tobacco Control Studies, Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary, University of London (Drs Hajek and McRobbie and Ms Myers), and Cancer Research United Kingdom Health Behaviour Research Centre, University College (Mr Stapleton), and Barts and The London National Health Service Trust (Dr Dhanji), London, England.

    Arch Intern Med. 2011;171(8):770-777. doi:10.1001/archinternmed.2011.138

    Background  The use of varenicline tartrate alleviates postquit withdrawal discomfort, but it also seems to reduce the “reward” associated with smoking. The current treatment schedule, which commences 1 week before quitting, relies primarily on the first mechanism. We set out to determine whether increasing the prequit medication period renders cigarettes less satisfying and facilitates quitting.

    Methods  One hundred one smokers attending a stop-smoking clinic in London, United Kingdom, were randomly allocated to receive varenicline for 4 weeks before the target quit date (TQD) or to receive placebo for 3 weeks before the TQD, followed by varenicline for 1 week before the TQD. In both groups, standard varenicline treatment was given for 3 months after the TQD. Measures included smoking satisfaction and smoke intake before quitting, urges to smoke and withdrawal discomfort after quitting, and sustained abstinence from the TQD to 3 months.

    Results  Varenicline preloading reduced prequit enjoyment of smoking (P = .004) and smoke intake (P < .001), with 36.7% of participants reducing their cotinine concentrations by more than 50% (reducers). Varenicline preloading did not affect postquit withdrawal symptoms, but it increased 12-week abstinence rates (47.2% in the varenicline arm vs 20.8% in the placebo arm, P = .005). The effect was particularly strong among the reducers in the varenicline arm (66.7% in reducers vs 22.6% in nonreducers, P = .002). Varenicline preloading was well tolerated.

    Conclusions  Although several issues remain to be clarified, varenicline preloading can generate a substantial reduction in ad lib smoking and enhance 12-week quit rates. Current treatment schedules may lead to suboptimal treatment results. Trials with longer follow-up periods are needed to corroborate these findings.

    Trial Registration  clinicaltrials.gov Identifier: NCT00789074