Clinical trial NCT01454362: Effect of the Electronic Cigarette on Withdrawal Symptoms
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental and Behavioral Disorders
Withdrawal State
Keywords: nicotine
inhalator
electronic cigarette
tobacco
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2011-10-19
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of E-C and Inhalator in Effects on Withdrawal Over 24 Hours of Use.
timeFrame: 24 hours
Secondary outcomes:
measure: Change in Salivary Cotinine Levels After 24-hour Use.
timeFrame: 24 hours
measure: Reinforcing Effects of Smoking
timeFrame: 24 hours
measure: Airway Sensations
timeFrame: 24 hours
measure: Product Satisfaction
timeFrame: 24 hours
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Tobacco Dependence Research Unit
Study officials:
affiliation: Queen Mary University of London
name: Hayden J McRobbie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1007/s00213-004-1923-6. Epub 2004 Jun 4.
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. doi: 10.1017/s0033291700005705.
citation: 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. doi: 10.1016/j.drugalcdep.2007.04.002. Epub 2007 May 7.
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. doi: 10.1016/j.pbb.2003.07.002.