Mental and Behavioral Disorders Clinical Trial
— ECIG24Official 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
| Verified date | March 2019 |
| Source | Queen Mary University of London |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 51 |
| Est. completion date | March 2013 |
| Est. primary completion date | March 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Tobacco Dependence Research Unit | London |
| Lead Sponsor | Collaborator |
|---|---|
| Queen Mary University of London |
United Kingdom,
Cappelleri JC, Bushmakin AG, Baker CL, Merikle E, Olufade AO, Gilbert DG. Multivariate framework of the Brief Questionnaire of Smoking Urges. Drug Alcohol Depend. 2007 Oct 8;90(2-3):234-42. Epub 2007 May 7. — View Citation
Rose JE, Behm FM, Westman EC, Bates JE, Salley A. Pharmacologic and sensorimotor components of satiation in cigarette smoking. Pharmacol Biochem Behav. 2003 Sep;76(2):243-50. — View Citation
West R, Hajek P. Evaluation of the mood and physical symptoms scale (MPSS) to assess cigarette withdrawal. Psychopharmacology (Berl). 2004 Dec;177(1-2):195-9. Epub 2004 Jun 4. — View Citation
West RJ, Hajek P, Belcher M. Severity of withdrawal symptoms as a predictor of outcome of an attempt to quit smoking. Psychol Med. 1989 Nov;19(4):981-5. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. |
24 hours | |
| 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). |
24 hours | |
| 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. | 24 hours | |
| Secondary | Airway Sensations | Sensory effects: Measure of airway sensations (throat and chest). Mean enjoyment score (rating 0-4), higher the score indicating increased enjoyment. | 24 hours | |
| Secondary | Product Satisfaction | Product satisfaction: Ratings of product satisfaction (when compared to cigarettes). Rating 0-4, with higher value indicating higher satisfaction ratings. | 24 hours |