Trial Outcomes & Findings for Smoking Cessation and Reduction With an Electronic Nicotine Delivery Device (ENDD) (NCT NCT01195597)

Results Overview

Participants were monitored for up to 24 weeks. This is the number of smokers who sustained 50% reduction in the number of cig/day at week-24 from baseline (reducers).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

number of cigarettes/day as assessed at week 24

Results posted on

2013-01-09

Participant Flow

Healthy smokers 18-60 years old, smoking ≥ 15 factorymade cigarettes per day (cig/day) for at least the past 10 years and not currently attempting to quit smoking or wishing to do so in the next 30 days were recruited, Italy. None of the participants reported a history of alcohol and drug use, major depression or other psychiatric conditions.

Participant milestones

Participant milestones
Measure	ENDD Group Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges.
Overall Study STARTED	40
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Smoking Cessation and Reduction With an Electronic Nicotine Delivery Device (ENDD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ENDD Group n=40 Participants Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age Continuous	42.9 years STANDARD_DEVIATION 8.8 • n=99 Participants
Sex: Female, Male Female	14 Participants n=99 Participants
Sex: Female, Male Male	26 Participants n=99 Participants
Region of Enrollment Italy	40 participants n=99 Participants

PRIMARY outcome

Timeframe: number of cigarettes/day as assessed at week 24

Population: Intention to treat (ITT)

Participants were monitored for up to 24 weeks. This is the number of smokers who sustained 50% reduction in the number of cig/day at week-24 from baseline (reducers).

Outcome measures

Outcome measures
Measure	Smokers Not Willing to Quit n=40 Participants 7.4 mg nicotine cartridges ("Original" cartridges; Arbi Group Srl, Milano, Italy)
Sustained 50% Reduction in the Number of Cig/Day at Week-24 From Baseline (Reducers)	13 number of participants Interval 20.0 to 50.0

SECONDARY outcome

Timeframe: number of cigarettes/day as assessed at week 24

Population: Intention to treat (ITT)

Participants were monitored for up to 24 weeks. This is the number of partecipants who sustained 80% reduction at week 24

Outcome measures

Outcome measures
Measure	Smokers Not Willing to Quit n=40 Participants 7.4 mg nicotine cartridges ("Original" cartridges; Arbi Group Srl, Milano, Italy)
Sustained 80% Reduction in the Number of Cig/Day at Week- 24 From Baseline (Heavy Reducers)	5 number of participants Interval 25.0 to 35.0

Adverse Events

ENDD Group

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ENDD Group n=40 participants at risk Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges.
Skin and subcutaneous tissue disorders troat irritation	27.5% 11/40 • Number of events 40 • 6 months daily questionnaire
Skin and subcutaneous tissue disorders mouth irritation	27.5% 11/40 • Number of events 40 • 6 months daily questionnaire

Additional Information

Prof Riccardo Polosa

University of Catania

Phone: 0957436413

Email: [email protected], [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place