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Abuse Liability of Four Modern Oral Nicotine Products

NCT07685795 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-07-06

No results posted yet for this study

Summary

This is a single-site, open-label, randomized, 6-way crossover study designed to evaluate elements of abuse liability (AL) including subjective effects, physiological measures (pharmacodynamics \[PD\]), and plasma nicotine uptake (pharmacokinetics \[PK\]) during controlled monitored use and following ad libitum use of the study investigational products (IPs) by generally healthy smokers who are also users of smokeless tobacco.

Conditions

  • Smoking
  • Smoking Behaviors
  • Tobacco Use
  • Tobacco Smoking

Interventions

OTHER

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

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

OTHER

Wintergreen (fleece A), 12 mg nicotine

Wintergreen (fleece A), 12 mg nicotine

OTHER

Wintergreen (fleece A), 9 mg nicotine

Wintergreen (fleece A), 9 mg nicotine

OTHER

Wintergreen (fleece B), 9 mg Nicotine

Wintergreen (fleece B), 9 mg Nicotine

OTHER

Watermelon Mint (fleece A), 9 mg Nicotine

Watermelon Mint (fleece A), 9 mg Nicotine

OTHER

UB moist snuff (UB MST), either loose or portioned (pouched).

UB moist snuff (UB MST), either loose or portioned (pouched).

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
2026-07-15
Primary Completion
2026-09-15
Completion
2027-01-31

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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 NCT07685795 on ClinicalTrials.gov