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CSD201001: Study to Assess Elements of Abuse Liability for Three Nicotine Pouches

NCT05129657 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-04-30

No results posted yet for this study

Summary

This is a two-site, open-label, randomized, 5-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 and following ad libitum use of the study investigational products (IPs) by generally healthy smokers.

Conditions

  • Smoking
  • Tobacco Use
  • Tobacco Smoking

Interventions

OTHER

Product A

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

OTHER

Product B

P1012914, A nicotine pouch product with 4 mg of nicotine

OTHER

Product C

P1012915, A nicotine pouch product with 8 mg of nicotine

OTHER

Product D

P1012919, A nicotine pouch product with 12 mg of nicotine

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
2021-11-02
Primary Completion
2022-06-24
Completion
2022-06-24

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 NCT05129657 on ClinicalTrials.gov