Electronic cigarette for smoking cessation: A randomized, placebo controlled, double blind, double dummy, multicenter trial comparing electronic cigarettes with nicotine to varenicline and to electronic cigarettes without nicotine, the ECSMOKE trial
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Hôpital Pitié-Salpêtrière, Paris, France
Publication date: 2020-10-22
Tob. Prev. Cessation 2020;6(Supplement):A101
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Background and Rational:
Electronic cigarettes (EC), mainly with nicotine content, are widely used worldwide. Although the number of publications about its use is increasing exponentially, evidence-based, unbiased, conclusive, head-to-head comparisons about its efficacy and safety as an aid for smoking cessation are lacking.

Methods and analysis:
Design: Randomized, placebo and reference treatment-controlled, multicenter, double-blind, double-dummy, parallel-group trial. Participants: Smokers smoking at least ten cigarettes/day in the past year and motivated to quit, aged 18–70 years.

1. EC without nicotine (ECwoN) plus placebo tablets of varenicline administered by oral route: placebo condition
2. EC with nicotine (ECwN) plus placebo tablets of varenicline: ECwN condition Voltage regulated electronic cigarettes will be used with liquid containing 12 mg/mL of nicotine for ad libitum use—flavour, blond tobacco.
3. ECwoN plus 0.5 mg varenicline tablets (Ref.): varenicline condition. Varenicline administered according to the marketing authorisation. Treatment duration: 1 week + 3 months. Follow-up at six months.

Primary outcome: continuous smoking abstinence rate (CAR) (abstinence from conventional/combustible cigarettes) during the last four weeks (weeks 9 to 12) of the treatment period defined as self-report of no smoking during the previous two weeks and expired air CO ≤8 ppm at Visit 4 at Week 10 after the target quit date (TQD), i.e. 11 weeks after treatment initiation AND at Visit 5, Week 12 after TQD, i.e. 13 weeks after treatment initiation. Secondary outcomes: Safety profile; continuous abstinence rate from target quit date, point prevalence abstinence rate; CAR confirmed by urinary anabasine concentration; changes in cigarettes/day consumption, craving for tobacco and withdrawal symptoms with respect to baseline. Between 17 October 2018 and 10 March 2020, 328 smokers were randomised.

Occasional honoraria from Pfizer for presentations at meetings in the last 3 years.
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