A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery System Products

Summary

This will be a randomized, open-label, 8-way crossover, single-site study designed to evaluate elements of abuse liability (AL), including subjective effects and physiological measures (pharmacodynamics \[PD\]), and plasma nicotine uptake (pharmacokinetics \[PK\]) during and following ad libitum use of electronic nicotine delivery system (ENDS) investigational products (IPs). The study will be conducted in a confinement setting among generally healthy adult smokers of combustible cigarettes and dual users of cigarettes and ENDS products.

Conditions

• Smoking Behaviors
• Smoking ( Cigarette)
• Tobacco Use

Interventions

OTHER

Fresh Mint 5% (3) 5.5W

Fresh Mint 5% (3) 5.5W

OTHER

Fresh Mint 5% (2) 6.5W

Fresh Mint 5% (2) 6.5W

OTHER

Usual Brand Cigarette

Usual Brand Cigarette

OTHER

Fresh Mint 5% (3) 6.5W

Fresh Mint 5% (3) 6.5W

OTHER

Golden Tobacco Chill 5% (4) 6.5W

Golden Tobacco Chill 5% (4) 6.5W

OTHER

Glacier Menthol 5% (4) 6.5W

Glacier Menthol 5% (4) 6.5W

OTHER

Fresh Mint 5% (4) 6.5W

Fresh Mint 5% (4) 6.5W

OTHER

Fresh Mint 5% (4) 4.5W

Fresh Mint 5% (4) 4.5W

Sponsors & Collaborators

• RAI Services Company

  lead INDUSTRY

Principal Investigators

• Milly Kanobe · Reynolds American

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-10-01

Primary Completion

2026-12-31

Completion

2027-04-30