The advent of electronic cigarette (e-cigarette) technologies represents one of the most significant developments in the last several decades, and provides a novel and promising strategy for substantially reducing the morbidity and mortality associated with smoking. However, serious concerns have been raised regarding the possibility that e-cigarettes will sustain a dependency on nicotine and that they may lead to continued use of conventional cigarettes known to be extremely harmful to health. Cigarette addiction critically involves a dependence on nicotine, but it is likely that other tobacco constituents contribute to dependence as well. Recent evidence suggests that non-nicotine tobacco alkaloids, or NNTAs (including anabasine, anatabine, nornicotine, and myosmine) may play a role in tobacco dependence. These alkaloids have been shown to augment the reinforcing effects of nicotine in animal models and to affect cravings in human smokers. E-cigarettes contain variable quantities of nicotine and NNTAs, but there is virtually no information available concerning the role of e-cigarette nicotine or NNTA content in influencing the concurrent use of cigarettes and e-cigarettes, when smokers attempt to switch from conventional combustible cigarettes to e-cigarettes. Additionally, it is not known whether the presence of nicotine and NNTAs in e- cigarettes may sustain dependence, making it difficult to relinquish these products. The proposed project will assess the acceptability, extent of switching behavior, and degree of dependence maintained when smokers are provided with e-cigarettes containing nicotine and NNTAs.
A single group of thirty smokers will be recruited for the study to provide initial data to inform follow-up randomized controlled trials. Dependence and concurrent use of e-cigarettes and cigarettes will be assessed by a battery of self-report, biochemical, and behavioral indices. This is not a tobacco cessation study and there is no intent to use e-cigarettes as a smoking cessation treatment. Smokers will be asked to use the e-cigarettes instead of their regular cigarettes during the study. E-cigarettes will not be used for the purpose of reducing urges, withdrawal or nicotine dependence; and e-cigarettes will not be described or used as a medical device or therapy. Specific Aim 1: To assess the extent of switching from combustible cigarettes to e-cigarettes delivering nicotine along with NNTAs. Switching will be assessed by self-report diaries and by reductions in expired air carbon monoxide, an index of combustible cigarette use. Specific Aim 2: To assess the acceptability of e-cigarettes delivering nicotine along with NNTAs. Ratings of user satisfaction and other subjective effects will be collected from participants, for both their customary brand of cigarettes and the e-cigarette to be used. Specific Aim 3: To determine the extent of dependence maintained during use of e-cigarettes delivering nicotine with NNTAs, as well as the relationship between dependence and self-reported use of cigarettes and e-cigarettes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
20
Participants will be asked to switch from cigarette use to use of e-cigarettes for eight weeks.
Duke Center for Smoking Cessation
Durham, North Carolina, United States
Change in expired air carbon monoxide (CO) to assess recent smoking
Self-reported changes in cigarette use from baseline to week 8, expressed as a percentage of baseline values, will be calculated, based on expired air carbon monoxide readings.
Time frame: Weeks 1-8
Mean volume of e-cigarette solution used per day to assess e-cigarette use.
The mean volume of solution used per day (by measuring the content and number of pods returned) will be calculated for each week.
Time frame: Weeks 1-8
Change in cigarette use, assessed by self-report in daily dairies
Self-reported changes in cigarette use from baseline to week 8, expressed as a percentage of baseline values, will be calculated, based on cigarette consumption recorded in daily diaries.
Time frame: Weeks 1-8
E-cigarette use, assessed by self-report in daily dairies
The self-reported use of e-cigarette pods, based on daily diaries, will be totaled for each week.
Time frame: Weeks 1-8
Change in Nicotine dependence
The change in level of nicotine dependence will be assessed by administering the Fagerstrom Test for Nicotine Dependence questionnaire, administered at baseline and at week 8.
Time frame: Weeks 1-8.
Satisfaction ratings
The satisfaction of the experimental e-cigarette formulation will be assessed using the modified Cigarette Evaluation Questionnaire, with wording adapted to e-cigarettes.
Time frame: Weeks 1-8.
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