NCT05320887 - 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)

Hatsukami DK, Perkins KA, Lesage MG, Ashley DL, Henningfield JE, Benowitz NL, Backinger CL, Zeller M
Nicotine reduction revisited: science and future directions. Tob Control. 2010 Oct;19(5):e1-10. doi: 10.1136/tc.2009.035584.
Henningfield JE, Benowitz NL, Slade J, Houston TP, Davis RM, Deitchman SD
Reducing the addictiveness of cigarettes. Council on Scientific Affairs, American Medical Association. Tob Control. 1998 Autumn;7(3):281-93. doi: 10.1136/tc.7.3.281.
Jarvis MJ, Bates C
Eliminating nicotine in cigarettes. Tob Control. 1999 Spring;8(1):106-7; author reply 107-9. No abstract available.
Kozlowski LT
Cigarette prohibition and the need for more prior testing of the WHO TobReg's global nicotine-reduction strategy. Tob Control. 2017 Mar;26(e1):e31-e34. doi: 10.1136/tobaccocontrol-2016-052995. Epub 2016 Jun 29. No abstract available.
Kozlowski LT
Let actual markets help assess the worth of optional very-low-nicotine cigarettes before deciding on mandatory regulations. Addiction. 2017 Jan;112(1):3-5. doi: 10.1111/add.13515. Epub 2016 Aug 23. No abstract available.
Kozlowski LT
Prospects for a nicotine-reduction strategy in the cigarette endgame: Alternative tobacco harm reduction scenarios. Int J Drug Policy. 2015 Jun;26(6):543-7. doi: 10.1016/j.drugpo.2015.02.001. Epub 2015 Feb 23.
Shatenstein S
Eliminating nicotine in cigarettes. Tob Control. 1999 Spring;8(1):106; author reply 107-9. No abstract available.
World Health Organization
WHO STUDY GROUP ON TOBACCO PRODUCT REGULATION. Report on the Scientific Basis of Tobacco Product Regulations: Fifth Report of a WHO Study Group. World Health Organ Tech Rep Ser. 2015;(989):1-234, back cover.

The Impact of Cigarette Nicotine Content, E-Cigarette Nicotine Content and E-Cigarette Flavoring on Smoking Behavior in an Electronic Tobacco Marketplace

Details for clinical trial NCT05320887

Clinical trial NCT05320887 - References