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Abuse Liability of Two Modern Oral Nicotine Pouched Products

NCT07595055 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-19

No results posted yet for this study

Summary

This is a single-site, open-label, randomized, 4-way 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 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

Modern Oral Pouch Wintergreen-A 9 mg Nicotine

-A 9 mg Nicotine

OTHER

Modern Oral Pouch Wintergreen-B 9 mg Nicotine

-B 9 mg Nicotine

OTHER

UB loose or pouched moist snuff

UB loose or pouched moist snuff

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
2026-06-15
Primary Completion
2026-07-31
Completion
2026-11-30

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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 NCT07595055 on ClinicalTrials.gov