Mental and Behavioral Disorders, Withdrawal State
Conditions
Keywords
nicotine, inhalator, electronic cigarette, tobacco
Brief summary
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.
Detailed description
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.
Interventions
DRUGNicotine
Inhalation of nicotine.
Sponsors
Queen Mary University of London
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of E-C and Inhalator in Effects on Withdrawal Over 24 Hours of Use. | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Salivary Cotinine Levels After 24-hour Use. | 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). |
| Reinforcing Effects of Smoking | 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. |
| Airway Sensations | 24 hours | Sensory effects: Measure of airway sensations (throat and chest). Mean enjoyment score (rating 0-4), higher the score indicating increased enjoyment. |
| Product Satisfaction | 24 hours | Product satisfaction: Ratings of product satisfaction (when compared to cigarettes). Rating 0-4, with higher value indicating higher satisfaction ratings. |
Countries
United Kingdom
Participant flow
Recruitment details
Participants were recruited at the Tobacco Dependence Research Unit in London between January 2013 and February 2013.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Electronic Cigarette First, 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. | 28 |
| Nicotine Inhalator First, 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. | 23 |
| Total | 51 |
Baseline characteristics
| Characteristic | Electronic Cigarette First, Then Nicotine Inhalator | Nicotine Inhalator First, Then Electronic Cigarette | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 22 Participants | 48 Participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 9 Participants |
| Sex: Female, Male Male | 23 Participants | 19 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 51 |
| other Total, other adverse events | 30 / 51 | 34 / 51 |
| serious Total, serious adverse events | 0 / 51 | 0 / 51 |
Outcome results
Primary
Comparison of E-C and Inhalator in Effects on Withdrawal Over 24 Hours of Use.
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.
Time frame: 24 hours
Population: Reporting group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electronic Cigarette | 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 |
| Nicotine Inhalator | Comparison of E-C and Inhalator in Effects on Withdrawal Over 24 Hours of Use. | 0.86 units on a scale | Standard Deviation 0.73 |
p-value: 0.17t-test, 2 sided
Secondary
Airway Sensations
Sensory effects: Measure of airway sensations (throat and chest). Mean enjoyment score (rating 0-4), higher the score indicating increased enjoyment.
Time frame: 24 hours
Population: Reporting group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electronic Cigarette | Airway Sensations | 1.65 units on a scale | Standard Deviation 1.05 |
| Nicotine Inhalator | Airway Sensations | 0.51 units on a scale | Standard Deviation 0.7 |
p-value: 0.001t-test, 2 sided
Secondary
Change in Salivary Cotinine Levels After 24-hour Use.
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).
Time frame: 24 hours
Population: Reporting group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electronic Cigarette | Change in Salivary Cotinine Levels After 24-hour Use. | -66.32 ng/ml | Standard Deviation 94.84 |
| Nicotine Inhalator | Change in Salivary Cotinine Levels After 24-hour Use. | -53.8 ng/ml | Standard Deviation 119.4 |
p-value: 0.43t-test, 2 sided
Secondary
Product Satisfaction
Product satisfaction: Ratings of product satisfaction (when compared to cigarettes). Rating 0-4, with higher value indicating higher satisfaction ratings.
Time frame: 24 hours
Population: Reporting group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electronic Cigarette | Product Satisfaction | 1.18 units on a scale | Standard Deviation 1.05 |
| Nicotine Inhalator | Product Satisfaction | 0.59 units on a scale | Standard Deviation 1.1 |
p-value: 0.003t-test, 2 sided
Secondary
Reinforcing Effects of Smoking
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.
Time frame: 24 hours
Population: Reporting group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electronic Cigarette | Reinforcing Effects of Smoking | 2 units on a scale | Standard Deviation 1.11 |
| Nicotine Inhalator | Reinforcing Effects of Smoking | 0.67 units on a scale | Standard Deviation 0.89 |
p-value: <0.001t-test, 2 sided