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A Study to Characterize Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouches in Adult Cigarette Smokers

NCT04846088 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2022-12-07

No results posted yet for this study

Summary

This study is designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following the use of nicotine pouches in cigarette smokers who have experience with use of smokeless tobacco (SST) \[e.g., snus, moist snuff\].

Conditions

  • Tobacco Use
  • Tobacco Smoking

Interventions

OTHER

Product A

A 4mg nicotine pouch product

OTHER

Product B

A 7mg nicotine pouch product

OTHER

Product C

A 7mg nicotine pouch product

OTHER

Product D

A 7mg nicotine pouch product

OTHER

Product E

A 7mg nicotine pouch product

OTHER

Product F

A 7mg nicotine pouch product

OTHER

Product G

A 7mg nicotine pouch product

OTHER

Product H

A 7mg nicotine pouch product

OTHER

Product I

A 7mg nicotine pouch product

Sponsors & Collaborators

  • British American Tobacco (Investments) Limited

    lead INDUSTRY

Principal Investigators

  • Debra Kelsh, MD · Altasciences Clinical Kansas, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-05
Primary Completion
2021-06-02
Completion
2021-06-02

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 NCT04846088 on ClinicalTrials.gov