Abuse Liability for Four Heated Tobacco Product (HTP) Consumables and Two HTP Devices

Summary

This is a single-site, open-label, randomized, 8-way crossover 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 the study investigational products (IPs) by generally healthy adult smokers.

Conditions

• Smoking
• Smoking Behaviors
• Tobacco Use
• Tobacco Smoking

Interventions

OTHER

Product A

Usual Brand filtered, non-menthol /menthol combustible cigarette

OTHER

Product N

Nicorette White Ice Mint 4 mg

OTHER

Product B

Signature Tobacco, Standard Mode, Device 1

OTHER

Product C

Signature Tobacco, Boost Mode, Device 1

OTHER

Product D

Roasted Tobacco, Standard Mode, Device 1

OTHER

Product E

Signature Tobacco, Standard Mode, Device 2

OTHER

Product F

Signature Tobacco, Boost Mode, Device 2

OTHER

Product G

Roasted Tobacco, Standard Mode, Device 2

OTHER

Product H

Fresh Menthol, Standard Mode, Device 1

OTHER

Product I

Fresh Menthol, Boost Mode, Device 1

OTHER

Product J

Menthol Capsule (Crushed), Standard Mode, Device 1

OTHER

Product K

Fresh Menthol, Standard Mode, Device 2

OTHER

Product L

Fresh Menthol, Boost Mode, Device 2

OTHER

Product M

Menthol Capsule (Crushed), Standard Mode, Device 2

Sponsors & Collaborators

• RAI Services Company

  lead INDUSTRY

Principal Investigators

• Brian Keyser · 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

2026-01-31

Primary Completion

2026-06-30

Completion

2026-12-31