NCT03294356

CSD170304: Study to Assess Nicotine Uptake in Smokers From Electronic and Combustible Cigarettes

CSD170304: An Unblinded, Parallel, Randomized Study to Assess Nicotine Uptake in Smokers From Electronic and Combustible Cigarettes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: RAI Services Company · Industry
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

Summary

To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of five different marketed electronic cigarettes, or one combustible cigarette (CC). Furthermore, to measure overall product liking by subjects to assess potential willingness to seek out the Electronic Cigarette (EC) again in the future.

Detailed description

This will be a single-center, randomized, open-label, parallel study during which up to 210 healthy adult subjects, consisting of 35 subjects per product group, will be enrolled. Subjects will be evaluated for plasma nicotine uptake, as well as overall product liking. The study will involve the use of five different marketed ECs or one CC in tobacco consumers who are exclusive smokers (i.e., naïve EC users) or dual users of cigarettes and ECs (i.e., intermittent EC users).

Conditions

• Smoking

Interventions

Type	Name	Description
OTHER	FT210771	An electronic cigarette
OTHER	FT210751	An electronic cigarette
OTHER	6T30134157764	An electronic cigarette
OTHER	G41A7C071	An electronic cigarette
OTHER	M011161212	An electronic cigarette
OTHER	FT21002	A combustible cigarette

Timeline

• Start date: 2017-09-13
• Primary completion: 2017-11-02
• Completion: 2017-11-02
• First posted: 2017-09-27
• Last updated: 2017-11-14

Locations

5 sites across 1 country: United States