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Abuse Liability for Five Modern Oral Nicotine Products

NCT07132814 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-30

No results posted yet for this study

Summary

This is a two-site, open-label, randomized, 4-way (2 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 A

Usual Brand (UB) filtered, non-menthol or menthol combustible cigarette

OTHER

Product B

8 mg nicotine oral product

OTHER

Product C

12 mg nicotine oral product

OTHER

Product D

6 mg nicotine oral product

OTHER

Product E

8 mg nicotine oral product

OTHER

Product F

8 mg nicotine oral product

OTHER

Product N

Nicorette® White Ice Mint 4 mg nicotine polacrilex gum

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
2025-12-15
Primary Completion
2026-04-15
Completion
2026-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07132814 on ClinicalTrials.gov