At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Controlled, Six-way Crossover Clinical Study To Characterize The Nicotine Pharmacokinetics And Subjective Effects Of Four Heated Tobacco Products In Adult Menthol And Nonmenthol Cigarette Smokers
In Brief
A clinical study evaluating Product A, Product B, and 4 other interventions for Tobacco Use. Completed, enrolled 80 participants across 3 sites.
Detailed Summary
This is a randomized, controlled, six-way crossover clinical study to characterize the nicotine PK (pharmacokinetic) and subjective effects of HTPs (Heated Tobacco Products) comprised of 2 menthol varieties and 2 tobacco flavor varieties (Ploom® HTPs, Japan Tobacco Inc.) in adult menthol and non-menthol combustible cigarette smokers (males and females between the ages of 22 and 65). The study will include participants' UBCC (Usual Brand Combustible Cigarette) and a nicotine gum (Nicorette®) as high and low abuse liability reference products, respectively, to the HTP. Study participation is expected to last up to 34 days, including a 28-day screening period (that includes a 5-day at-home HTP product trial period), and a 6-day in-clinic confinement period (from Check-in \[Day -1\] through the end-of-study \[EOS\] visit on Day 6).
Study Details
Timeline
Interventions
Use of Product A in controlled use and ad libitum use sessions
Use of Product B in controlled use and ad libitum use sessions
Use of Product C in controlled use and ad libitum use sessions
Use of Product D in controlled use and ad libitum use sessions
Use of Product E in controlled use and ad libitum use sessions
Use of Product F in controlled use and ad libitum use sessions