CSD210202: A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery Systems
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Smoking
- Smoking Behaviors
- Tobacco Smoking
- Tobacco Use
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 21 years and 60 years
- Gender
- Both males and females
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 a...
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.
Tracking Information
- NCT #
- NCT04751461
- Collaborators
- Not Provided
- Investigators
- Study Director: Jason Hong, MD RAIS