Trial Outcomes & Findings for Effect of the Electronic Cigarette on Withdrawal Symptoms (NCT NCT01454362)

Last Updated: 2019-03-27

Results Overview

Mood and Physical Symptoms Scale (MPSS): Measure of severity of urges to smoke and tobacco withdrawal symptoms. A five-point scale is used to rate 'How much of the time have you felt the urge to smoke in the past week?' ((1) 'not at all' to (5) 'almost all of the time') and 'How strong have the urges been?' ('no urges' to 'very strong'). Clients also rate depression, irritability, restlessness, hunger, poor concentration, poor sleep at night, and anxiety during the past week ((1)=not at all to (5)=extremely). The combined score to questions on depression, irritability, restlessness, hunger, and poor concentration are averaged to give the MPSS score. A higher score means a more severe rating of withdrawal. The primary outcome is a change in MPSS score between baseline and 24 hours (value at 24 hours minus value at baseline). Therefore, a smaller change in MPSS score represents a smaller increase in tobacco withdrawal symptoms.

Recruitment status

COMPLETED

Study phase

Target enrollment

51 participants

Primary outcome timeframe

24 hours

Results posted on

2019-03-27

Participant Flow

Participants were recruited at the Tobacco Dependence Research Unit in London between January 2013 and February 2013.

Inclusion Criteria Smoking at least 12 cigarettes per day; first cigarette smoked within 60 mins of waking; willing to abstain from smoking for one day in 2 consecutive weeks. Exclusion Criteria Under 18s; current psychiatric illness; planning pregnancy, pregnant or breastfeeding; enrolled in other research; used EC or inhaler before.

Participant milestones

Participant milestones
Measure	Electronic Cigarette Then, Nicotine Inhalator Randomised to receive electronic cigarette at the first session. Tested at study session then given to use ad-lib over 24 hours. Participants then returned to the clinic. 1 week wash out period. Asked to return to clinic to receive Nicotine Inhalator. Tested at clinic then given product to use ad-lib over 24 hours. Participants then returned to the clinic. Nicotine: Inhalation of nicotine.	Nicotine Inhalator Then, Electronic Cigarette Randomised to receive Nicotine Inhalator at the first session. Tested at study session then given to use ad-lib over 24 hours. Participants then returned to the clinic. 1 week wash out period. Asked to return to clinic to receive electronic cigarette. Tested at clinic then given product to use ad-lib over 24 hours. Participants then returned to the clinic.
Overall Study STARTED	28	23
Overall Study COMPLETED	28	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of the Electronic Cigarette on Withdrawal Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Electronic Cigarette First, Then Nicotine Inhalator n=28 Participants Randomised to receive electronic cigarette at the first session. Tested at study session then given to use ad-lib over 24 hours. Participants then returned to the clinic. 1 week wash out period. Asked to return to clinic to receive Nicotine Inhalator. Tested at clinic then given product to use ad-lib over 24 hours. Participants then returned to the clinic.	Nicotine Inhalator First, Then Electronic Cigarette n=23 Participants Randomised to receive Nicotine Inhalator at the first session. Tested at study session then given to use ad-lib over 24 hours. Participants then returned to the clinic. 1 week wash out period. Asked to return to clinic to receive electronic cigarette. Tested at clinic then given product to use ad-lib over 24 hours. Participants then returned to the clinic.	Total n=51 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	19 Participants n=7 Participants	42 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: Reporting group

Outcome measures

Outcome measures
Measure	Electronic Cigarette n=51 Participants All study participants.	Nicotine Inhalator n=51 Participants All study participants.
Comparison of E-C and Inhalator in Effects on Withdrawal Over 24 Hours of Use.	0.73 units on a scale Standard Deviation 0.64	0.86 units on a scale Standard Deviation 0.73

SECONDARY outcome

Timeframe: 24 hours

Population: Reporting group

Cotinine is a measure sensitive enough to detect effects of a switch to different nicotine products and salivary cotinine was shown to be dependent on nicotine mouth exposure. The results show the mean change in salivary cotinine in each study arm (all study participants).

Outcome measures

Outcome measures
Measure	Electronic Cigarette n=49 Participants All study participants.	Nicotine Inhalator n=49 Participants All study participants.
Change in Salivary Cotinine Levels After 24-hour Use.	-66.32 ng/ml Standard Deviation 94.84	-53.8 ng/ml Standard Deviation 119.4

SECONDARY outcome

Timeframe: 24 hours

Population: Reporting group

Modified Cigarette Evaluation Questionnaire (mCEQ): Measure of reinforcing effects of smoking (pleasant feeling). Mean pleasant feeling from using product (rating 0-4). Higher value indicating the higher rating of pleasure.

Outcome measures

Outcome measures
Measure	Electronic Cigarette n=51 Participants All study participants.	Nicotine Inhalator n=51 Participants All study participants.
Reinforcing Effects of Smoking	2 units on a scale Standard Deviation 1.11	0.67 units on a scale Standard Deviation 0.89

SECONDARY outcome

Timeframe: 24 hours

Population: Reporting group

Sensory effects: Measure of airway sensations (throat and chest). Mean enjoyment score (rating 0-4), higher the score indicating increased enjoyment.

Outcome measures

Outcome measures
Measure	Electronic Cigarette n=51 Participants All study participants.	Nicotine Inhalator n=51 Participants All study participants.
Airway Sensations	1.65 units on a scale Standard Deviation 1.05	0.51 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 24 hours

Population: Reporting group

Product satisfaction: Ratings of product satisfaction (when compared to cigarettes). Rating 0-4, with higher value indicating higher satisfaction ratings.

Outcome measures

Outcome measures
Measure	Electronic Cigarette n=51 Participants All study participants.	Nicotine Inhalator n=51 Participants All study participants.
Product Satisfaction	1.18 units on a scale Standard Deviation 1.05	0.59 units on a scale Standard Deviation 1.1

Adverse Events

Electronic Cigarette

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Nicotine Inhalator

Serious events: 0 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Electronic Cigarette n=51 participants at risk All study participants used product.	Nicotine Inhalator n=51 participants at risk All study participants used product.
Cardiac disorders Dyspnoea	15.7% 8/51 • Number of events 8 • 24 hours after product use Adverse effects questionnaire (adapted from Hajek et al, 1989)	11.8% 6/51 • Number of events 6 • 24 hours after product use Adverse effects questionnaire (adapted from Hajek et al, 1989)
Cardiac disorders Dyspnoea at rest	9.8% 5/51 • Number of events 5 • 24 hours after product use Adverse effects questionnaire (adapted from Hajek et al, 1989)	3.9% 2/51 • Number of events 2 • 24 hours after product use Adverse effects questionnaire (adapted from Hajek et al, 1989)
Cardiac disorders Chest pain	11.8% 6/51 • Number of events 6 • 24 hours after product use Adverse effects questionnaire (adapted from Hajek et al, 1989)	7.8% 4/51 • Number of events 4 • 24 hours after product use Adverse effects questionnaire (adapted from Hajek et al, 1989)
Cardiac disorders Chest discomfort	13.7% 7/51 • Number of events 7 • 24 hours after product use Adverse effects questionnaire (adapted from Hajek et al, 1989)	5.9% 3/51 • Number of events 3 • 24 hours after product use Adverse effects questionnaire (adapted from Hajek et al, 1989)
Respiratory, thoracic and mediastinal disorders Wheezing	13.7% 7/51 • Number of events 7 • 24 hours after product use Adverse effects questionnaire (adapted from Hajek et al, 1989)	15.7% 8/51 • Number of events 8 • 24 hours after product use Adverse effects questionnaire (adapted from Hajek et al, 1989)
Respiratory, thoracic and mediastinal disorders Cough	27.5% 14/51 • Number of events 14 • 24 hours after product use Adverse effects questionnaire (adapted from Hajek et al, 1989)	35.3% 18/51 • Number of events 18 • 24 hours after product use Adverse effects questionnaire (adapted from Hajek et al, 1989)
Respiratory, thoracic and mediastinal disorders Productive cough	23.5% 12/51 • Number of events 12 • 24 hours after product use Adverse effects questionnaire (adapted from Hajek et al, 1989)	17.6% 9/51 • Number of events 9 • 24 hours after product use Adverse effects questionnaire (adapted from Hajek et al, 1989)
Nervous system disorders Dizziness	17.6% 9/51 • Number of events 9 • 24 hours after product use Adverse effects questionnaire (adapted from Hajek et al, 1989)	17.6% 9/51 • Number of events 9 • 24 hours after product use Adverse effects questionnaire (adapted from Hajek et al, 1989)
Nervous system disorders Headache	19.6% 10/51 • Number of events 10 • 24 hours after product use Adverse effects questionnaire (adapted from Hajek et al, 1989)	17.6% 9/51 • Number of events 9 • 24 hours after product use Adverse effects questionnaire (adapted from Hajek et al, 1989)
Nervous system disorders Sleep disturbance	13.7% 7/51 • Number of events 7 • 24 hours after product use Adverse effects questionnaire (adapted from Hajek et al, 1989)	9.8% 5/51 • Number of events 5 • 24 hours after product use Adverse effects questionnaire (adapted from Hajek et al, 1989)
Eye disorders Visual impairement	7.8% 4/51 • Number of events 4 • 24 hours after product use Adverse effects questionnaire (adapted from Hajek et al, 1989)	3.9% 2/51 • Number of events 2 • 24 hours after product use Adverse effects questionnaire (adapted from Hajek et al, 1989)
Psychiatric disorders Disturbances in attention	17.6% 9/51 • Number of events 9 • 24 hours after product use Adverse effects questionnaire (adapted from Hajek et al, 1989)	29.4% 15/51 • Number of events 15 • 24 hours after product use Adverse effects questionnaire (adapted from Hajek et al, 1989)
Gastrointestinal disorders Nausea	13.7% 7/51 • Number of events 7 • 24 hours after product use Adverse effects questionnaire (adapted from Hajek et al, 1989)	21.6% 11/51 • Number of events 11 • 24 hours after product use Adverse effects questionnaire (adapted from Hajek et al, 1989)

Additional Information

Dr Hayden McRobbie

Queen Mary University of London

Phone: 0207 882 7260

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place