NCT04751461

CSD210202: A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery Systems

CSD210202: An Unblinded, Randomized, Crossover, Confinement Study to Assess Nicotine Uptake From Electronic Nicotine Delivery Systems

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: RAI Services Company · Industry
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, randomized, 5-way crossover study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following an ad libitum use of Electronic Nicotine Delivery System (ENDS) investigational products (IPs) in a confinement setting by generally healthy combustible cigarette (CC) smokers.

Detailed description

Potential subjects will complete a pre-screening interview and a Screening Visit to assess their eligibility within 45 days prior to enrollment, randomization and confinement. Following the Screening Visit, eligible subjects will be scheduled for a check-in and randomization visit. At the check-in and randomization visit, subjects' continued eligibility will be confirmed prior to being randomized to a product use sequence and beginning their 6 nights and 7 days of confinement. Starting on study Day 1, subject will start a Pre-study ENDS IP Acclimation Period through Day 2. Subjects will be asked to acclimate to each of the ENDS IP at least once, while having access to their usual brand (UB) cigarettes for ad libitum use. Starting on Day 3, subjects will participate in five separate Test Sessions for nicotine PK assessment, one for each ENDS IP. For approximately a half day prior to each respective Test Session (starting on Day 2), subjects will use their assigned ENDS IP for the following day's Test Session at least twice.

Conditions

• Smoking
• Smoking Behaviors
• Tobacco Use
• Tobacco Smoking

Interventions

Type	Name	Description
OTHER	Product A	P0213420, a 1.8% nicotine ENDS product
OTHER	Product B	P0213520, a 1.8% nicotine ENDS product
OTHER	Product C	P0211220, a 1.8% nicotine ENDS product
OTHER	Product D	P0211820, a 1.8% nicotine ENDS product
OTHER	Product E	P0213417, a 2.4% nicotine ENDS product

Timeline

• Start date: 2021-02-23
• Primary completion: 2021-04-20
• Completion: 2021-04-20
• First posted: 2021-02-12
• Last updated: 2022-06-24

Locations

1 site across 1 country: United States