Skip to main content
OpenTrials
Completed

NCT Number: NCT01454362

Effect of the Electronic Cigarette on Withdrawal Symptoms

Study rationale: Sensory/behavioural elements of smoking play a role in smoking behaviour and may have a potential to assist smoking cessation. Among current treatments for smokers, only the nicotine inhalator is attempting to address such factors. The inhalator's efficacy does not exceed that of the other nicotine replacement therapy (NRT) products, but it mimics the relevant sensory input to only a limited extent, and its nicotine delivery is dependent on intensive puffing. Recently a new product, the Electronic Cigarette (E-C) has become available, which provides a more realistic behaviour and sensory replacement for smoking and can provide good nicotine levels with less effort.

Primary objective: To compare E-C and nicotine inhalator in their effects on tobacco withdrawal symptoms over 24hr abstinence.

Hypotheses: E-C will be more effective than the inhalator in reducing withdrawal symptoms and craving and elicit more favorable user ratings. It will also provide higher nicotine levels.

Study design: In a cross-over study, participants will be randomized to the sequence of conditions and provide baseline measures and samples for salivary cotinine analysis. They will be asked to abstain from smoking their usual cigarettes and use the allocated product over 24 hours. They will return to the study centre the following day, and complete measures of craving and withdrawal, ratings of subjective and sensory effects of the products, product satisfaction, and adverse effects. They will also provide saliva samples for cotinine analysis. Abstinence from smoking will be verified with CO readings.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Mental and Behavioral Disorders Behavior Mental Disorders Smoking Vaping Withdrawal State

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tobacco Dependence Research Unit

London, E1 2JH, United Kingdom

About this study

There is considerable interest in E-Cs at the moment and the study would provide information on whether the E-C surpasses the tried and tested nicotine inhalator. If so, it would open a possibility of its utilization in smoking cessation, and provide encouragement for further examination of the role of sensorimotor replacements in the treatment of tobacco dependence.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Volunteers smoking at least 12 cigarettes per day
  • First cigarette smoked within 60 minutes of waking up
  • Willing to abstain from smoking for one day in 2 consecutive weeks.

Exclusion criteria

  • Under 18 years of age
  • Current psychiatric illness
  • Pregnant or breastfeeding
  • Enrollment in other research projects
  • Used electronic cigarette and/or nicotine inhalator before

Treatment and study plan

nicotine

Drug

Inhalation of nicotine.

Other names: Nicorette inhalator

Primary outcomes

  1. Comparison of E-C and Inhalator in Effects on Withdrawal Over 24 Hours of Use.

    Time frame: 24 hours

    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.

Secondary outcomes

  1. Change in Salivary Cotinine Levels After 24-hour Use.

    Time frame: 24 hours

    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).

  2. Reinforcing Effects of Smoking

    Time frame: 24 hours

    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.

  3. Airway Sensations

    Time frame: 24 hours

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

  4. Product Satisfaction

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Registry information

Official study title

Phase 4 Study to Compare of the Effects of the Electronic Cigarette and Nicotine Inhalator on Tobacco Withdrawal Symptoms Over 24 Hours of Abstinence

Acronym: ECIG24

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 19, 2011
Registry last updated
Mar 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.