NCT07323563

A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery Systems

A Randomized, Crossover, Confinement Study to Assess Nicotine Uptake From Electronic Nicotine Delivery System Products

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: RAI Services Company · Industry
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This will be an open-label, randomized, single-site, 8-way crossover study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters and overall product liking (OPL) following an ad libitum use of Electronic Nicotine Delivery System (ENDS) investigational products (IPs) in a confinement setting by generally healthy adult combustible cigarette smokers and smokers who also use ENDS products.

Detailed description

This study is designed to evaluate plasma nicotine PK parameters and OPL following use of ENDS IPs in generally healthy adult menthol or nonmenthol cigarette smokers and smokers who also use ENDS. A summary of study activities is provided below: Potential participants will undergo a pre-screening interview followed by a Screening Visit to assess their eligibility. The screening assessments will occur within 28 days prior to enrollment, randomization, and study confinement. Following the Screening Visit, eligible participants will be scheduled for a Checkin and Randomization visit. At this visit, participants' continued eligibility will be confirmed before participants are randomized to a product use sequence and begin a confinement period of 9 nights and 10 days. Beginning on Study Day 1, participants will start a ENDS IP familiarization period. During this period, participants will be required to use 3 ENDS IPs (Product A , Product B, and Product D) at least once for approximately 5 minutes, following which they will be permitted ad libitum smoking of their usual-brand (UB) cigarettes. Participants who also use other tobacco- and/or nicotine-containing products such as ENDS, smokeless tobacco, or modern oral nicotine products in addition to their UB cigarettes will not have access to those products during the study. Starting on Day 3, participants will participate in 8 separate test sessions (1 test session per day) to assess nicotine PK and OPL, with 1 session conducted for each ENDS IP. Beginning on Day 2 and each day prior to a subsequent test session, participants will undergo a product acclimation period during which they will use their assigned ENDS IP at least 4 times for approximately 5 minutes each use, in preparation for the following day's test session. Following this acclimation use, participants will be permitted ad libitum smoking of their UB cigarettes. The site will capture information on product usage during the product familiarization and acclimation periods. At the end of the product acclimation period and ad libitum use of the participant's UB cigarette, participants will abstain from use of all tobacco and nicotine-containing products for a minimum of 12 hours prior to each test session occurring on the following day. In addition, participants will be required to abstain from any caffeine-containing products for 4 hours prior to the start of each test session through the end of the test session. From Day 3 through Day 10, each participant will complete 8 test sessions, 1 per day, each lasting approximately 4 hours and evaluating 1 ENDS IP per session. During each test session, blood samples will be collected for nicotine PK assessments and participants will complete the OPL questionnaires. Each session will begin with an approximately 5-minute ad libitum use of a single ENDS IP. The order of the ENDS IPs used during these 8 test sessions will be determined by a randomized 8-sequence presentation schedule generated using a Williams Design. Each test session will be preceded by a 12hour abstention from all tobacco- and nicotine-containing products. Participants' use of the ENDS IP will be self-defined during the 5minute ad libitum IP use session; specific parameters around puff duration, volume, inter-puff interval, and quantity will not be prescribed. ENDS IP cartridges will be weighed within 4 hours before and after the test session on Days 3 to 10. Safety will be monitored throughout the study by the Principal Investigator (PI) (or qualified designee) by assessing adverse events (AEs), vital sign measurements, physical examinations (including an oral examination), and clinical laboratory tests. The Medical Monitor will be available for consultation during the duration of the study and for any follow-ups after study discharge

Conditions

• Smoking
• Smoking Behaviors
• Tobacco Use
• Tobacco Smoking

Interventions

Type	Name	Description
OTHER	Product A	Menthol Flavor, 5%
OTHER	Product B	Mint Flavor, 5%
OTHER	Product C	Tobacco Flavor, 5%
OTHER	Product D	Fruit Flavor, 5%
OTHER	Product E	Fruit Flavor, 5%
OTHER	Product F	Fruit Flavor, 5%
OTHER	Product G	Fruit Flavor, 5%
OTHER	Product H	Fruit Flavor, 5%

Timeline

• Start date: 2026-03-15
• Primary completion: 2026-05-15
• Completion: 2026-08-31
• First posted: 2026-01-07
• Last updated: 2026-01-07