CSD200907: A Study to Assess Elements of Abuse Liability for a Heated Tobacco Product With Four Non-Combusted Cigarette Variants

Summary

This is a single-center, open-label, randomized, 2-arm, within-arm cross-over 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 smokers.

Conditions

• Smoking
• Smoking Behaviors
• Tobacco Use
• Tobacco Smoking

Interventions

OTHER

Product A1

Usual Brand (UB) filtered, non-menthol cigarette

OTHER

Product B

40007388, A Non-Combusted Cigarette Variant and product use Mode A

OTHER

Product C

40007388, A Non-Combusted Cigarette Variant and product use Mode B

OTHER

Product D

40007386, A Non-Combusted Cigarette Variant and product use Mode B

OTHER

Product A2

Usual Brand (UB) filtered, menthol cigarette

OTHER

Product E

40007385, A Non-Combusted Cigarette Variant and product use Mode A

OTHER

Product F

40007385, A Non-Combusted Cigarette Variant and product use Mode B

OTHER

Product G

40007387, A Non-Combusted Cigarette Variant and product use Mode B

OTHER

Product H

40007386, A Non-Combusted Cigarette Variant and product use Mode B

OTHER

Product N

Nicorette® White Ice Mint 4 mg nicotine gum

Sponsors & Collaborators

• RAI Services Company

  lead INDUSTRY

Principal Investigators

• Milly Kanobe, PhD · RAIS

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

2021-11-29

Primary Completion

2022-02-27

Completion

2022-02-27

Countries

• United States

Study Locations