Mental and Behavioral Disorders Clinical Trial
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 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.
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. ;