Abuse Liability for Eight Electronic Nicotine Products
NCT07323511 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2026-01-07
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) in a confinement setting by generally healthy adult smokers of combustible cigarettes and dual users of cigarettes and ENDS products.
Conditions
- Smoking
- Smoking Behaviors
- Tobacco Use
- Tobacco Smoking
Interventions
- OTHER
-
Product A
Usual Brand (UB) filtered, menthol or non-menthol combustible cigarette
- OTHER
-
Product B
Tobacco Flavor, 5%
- OTHER
-
Product C
Tobacco Flavor, 1.5%
- OTHER
-
Product D
Tobacco Flavor, 5%
- OTHER
-
Product E
Tobacco Flavor, 2.4%
- OTHER
-
Product F
Tobacco Flavor, 5%
- OTHER
-
Product G
Mint Flavor, 5%
- OTHER
-
Product N
Nicorette® White Ice Mint 4 mg nicotine polacrilex gum
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
- 2026-02-15
- Primary Completion
- 2026-04-15
- Completion
- 2026-09-15
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