The aim of this study is to shed light on the importance of nicotine pharmacokinetics in switching to a reduced-harm product by fully matching the nicotine pharmacokinetics of smokers' usual brands of cigarettes. The primary objective is to ascertain the degree of smoking reduction when smokers attempt to switch to an e-cigarette that matches peak nicotine concentrations of a cigarette.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
The BIDI will be dispensed, and subjects will be instructed to use the BIDI as often as they like during the 12 week period, and to switch completely to the BIDI within 1 week. If, however, they do smoke any CC, they will also be instructed to use the BIDI immediately before each CC to relieve their craving as much as possible before smoking their usual brand. The BIDI will also be the first product that they are instructed to use each morning. Smokers will be told to try to completely substitute BIDI for CCs by the end of the first week of use.
Rose Research Center
Charlotte, North Carolina, United States
Rose Research Center
Raleigh, North Carolina, United States
Degree of Smoking Reduction
Change in expired air carbon monoxide (CO) at the end of the product use period
Time frame: After 12 Weeks
Degree of Smoking Reduction
Change in self-reported cigarettes smoked daily
Time frame: From Baseline to Week 12
Subjective response to an e-cigarette
To assess subjective satisfaction and other perceived rewarding or aversive effects accompanying e-cigarette use and combustible cigarette use using the modified (e-Cigarette) Cigarette Evaluation Questionnaire. This questionnaire contains five subscale scores: smoking satisfaction (satisfying, tastes good, enjoy smoking), psychological rewards (calms down, more awake, less irritable, helps concentrate, reduces hunger), aversion (dizziness, nauseated), enjoyment of respiratory tract sensations (single-item assessment), craving reduction (single-item assessment). Participants will be asked to assess the 12 items of the questionnaire on a 7-point scale, ranging from "not at all" to "extremely".
Time frame: From Baseline to Week 12
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