Successful BotanicBoost Clinical Trial!
Ethical Standards The authors assert that all procedures contributing to this clinical trial comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008
BotanicBoost Clinical Trial Findings Published in « Journal of Smoking Cessation » (2018. doi:10.1017/jsc.2018.14)
Introduction: Cigarette addiction results from both pharmacological effects of nicotine and the rewarding effects of associated cues, including respiratory tract sensations.
Aims: This study sought to evaluate the initial acceptability of a non-nicotine botanical formulation that provided similar respiratory tract cues.
Methods: Two active test products and matching placebos were evaluated. One test product, an e-cigarette-like device, delivered a visible aerosol upon pufﬁng; the other test product delivered an invisible vapor at ambient temperature. Test products delivered a botanical extract with ﬂavourings and vehicle; the placebos delivered ﬂavourings and vehicle only. Sixteen participants had 3-h ad libitum access to each test product and associated placebos, and were deprived of combustible cigarettes for 1 h before and throughout the 3-h evaluation period. Subjects rated the satisfaction (primary outcome) and other sensory qualities of the products. Safety evaluations included pulmonary function testing and monitoring vital signs.
Results: Satisfaction ratings (seven-point scale) were signiﬁcantly greater for the active e-cigarette-like condition; M = 3.18, SD = 1.04 versus M = 2.69, SD = 1.22. Safety evaluations showed no clinicallysigniﬁcant changes.
Conclusions: The results support the acceptability of a non-nicotine cigarette substitute in providing satisfaction to smokers. This approach merits further evaluation for acceptability in tobacco harm reduction and cessation.