Is a
Clinical Study attributes
NCT Number
Trial Recruitment Size
2200
Trial Sponsor
Clinical Trial Start Date
May 25, 2019
0Primary Completion Date
May 25, 2020
0Study Completion Date
May 25, 2020
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Device0
Intervention Name
IQOS0
E-CIG0
Interventional Trial Phase
Not Applicable0
Official Name
Randomized, Non-Inferiority Trial ComparingCigarette Consumption, Adoption Rates, Acceptability, Tolerability, and Tobacco Harm Reduction Potential in Smokers Switching to Heated Tobacco Products or Electronic Cigarettes: Study Protocol0
Last Updated
June 25, 2021
0Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
None (Open Label)0
Study summary
This is a 12-weeks, open label, non-inferiority trial comparing HTPs vs ECs in terms of efficacy, adoption rate and acceptability, tolerability, and tobacco harm reduction in 220 healthy smokers, not motivated to quit, randomized (1:1) to switch to one of these products. The duration of the study, from the enrollment to the study close out for all the patients at week 24 (follow-up), will be approximately 12 months. Enrollment period will last about 6 months with the support of a multi-channel advertising method. This will include location-based advertising on social networks, advertising in local media, information days organized within the city.
Timeline
No Timeline data yet.
Further Resources
No Further Resources data yet.
