Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Placebo Controlled, Double Blind, Double Dummy, Multicenter Trial Comparing Electronic Cigarettes With Nicotine to Varenicline and to Electronic Cigarettes Without Nicotine.
Brief 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.


Options:
A: Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Arm Label: varenicline; Type: EXPERIMENTAL; Interventions: Drug: Varenicline Tartarate | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo | Intervention Type: DRUG; Name: Varenicline Tartarate; Assigned to Arm(s): varenicline
B: Arm Label: varenicline; Type: ACTIVE_COMPARATOR; Interventions: Drug: varenicline tartrate (CP-526, 555-18) | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: varenicline tartrate (CP-526, 555-18); Assigned to Arm(s): varenicline | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): placebo
C: Arm Label: varenicline; Type: EXPERIMENTAL; Interventions: Drug: varenicline | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: varenicline; Assigned to Arm(s): varenicline | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo
D: Arm Label: Electronic cigarette condition; Type: EXPERIMENTAL; Interventions: Drug: Electronic cigarette with nicotine (ECwN) plus placebo tablets of varenicline | Arm Label: Varenicline condition; Type: ACTIVE_COMPARATOR; Interventions: Drug: Electronic cigarette without nicotine (ECwN) plus active varenicline tablets | Arm Label: Placebo condition; Type: PLACEBO_COMPARATOR; Interventions: Drug: Electronic cigarette without nicotine (ECwoN) plus placebo tablets of varenicline | Intervention Type: DRUG; Name: Electronic cigarette without nicotine (ECwN) plus active varenicline tablets; Assigned to Arm(s): Varenicline condition | Intervention Type: DRUG; Name: Electronic cigarette without nicotine (ECwoN) plus placebo tablets of varenicline; Assigned to Arm(s): Placebo condition | Intervention Type: DRUG; Name: Electronic cigarette with nicotine (ECwN) plus placebo tablets of varenicline; Assigned to Arm(s): Electronic cigarette condition

Answer: D