Randomized Trial of Electronic Cigarettes With or Without Nicotine in Smoking Cessation.
Status:
Recruiting
Trial end date:
2022-03-01
Target enrollment:
Participant gender:
Summary
Background:
Electronic cigarettes (EC) mainly containing nicotine (88-95 % of users) are widely and
growingly used worldwide. It is estimated that there were 1.7 million daily users in France
in 2016. Although the number of publications about its use is increasing exponentially, there
are no evidence based, unbiased, head-to-head comparison data about its efficacy as an aid to
smoking cessation. As of today, only two head-to-head randomized studies have been published,
both reported negative results at the main endpoint but they used first and second generation
EC delivering nicotine with low or unknown bioavailability. Recent EC deliver nicotine with
largely improved bioavailability.
One of the randomized studies compared EC with and without nicotine to nicotine patch and
reported similar smoking cessation rate at main outcome. However, there is no published,
double blind study comparing EC use with a well-studied, licensed smoking cessation
medication.
Superiority of EC with nicotine compared to EC without nicotine and to a reference smoking
cessation medication while collecting also straightforward information about safety, would
allow proposing EC with nicotine to the large population of smokers who intend to quit and
situate it among the approved smoking cessation treatments.
The clinical study's hypothesis:
EC containing nicotine can be considered as a nicotine replacement therapy having, probably,
a better bioavailability of nicotine than the marketed pharmaceutical NRTs, first line
medications of smoking cessation. It is therefore of interest to compare EC containing
nicotine to EC without nicotine but also to a reference medication with demonstrated efficacy
in smoking cessation. We hypothesize that EC with nicotine provides a higher smoking
abstinence rate than EC without nicotine and may be as good as varenicline, our reference
medication.