NCT03063034 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Fagerström K
Determinants of tobacco use and renaming the FTND to the Fagerstrom Test for Cigarette Dependence. Nicotine Tob Res. 2012 Jan;14(1):75-8. doi: 10.1093/ntr/ntr137.
Shepperd CJ, St Charles FK St, Lien M, Dixon M
Validation of methods for determining consumer smoked cigarette yields from cigarette filter analysis. Beitr Tabakforsch Int. 2006;22:176-184.
St Charles FK, Kabbani AA, Borgerding MF
Estimating tar and nicotine exposure: human smoking versus machine generated smoke yields. Regul Toxicol Pharmacol. 2010 Feb;56(1):100-10. doi: 10.1016/j.yrtph.2009.08.011.

CSD1602: A Crossover Study to Evaluate the Exposure to "Tar" and Nicotine From Two King Size Menthol Cigarette Products

Clinical trial NCT03063034 - References