MedTrace Logo

Nicotine Pharmacokinetics and Subjective Effects of Oral Nicotine Products Relative to Smokeless Tobacco in Adult Users

NCT06691386 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-01-17

No results posted yet for this study

Summary

The purpose of this study was to obtain information on nicotine exposure following the use of five oral tobacco-derived nicotine (OTDN) products relative to subjects' own brand moist smokeless tobacco (OBMST) product in adult moist smokeless tobacco (MST) users, as well as to characterize subjective effects under controlled use conditions. Male and female adult MST users between the ages of 22 to 65 years were recruited. The total duration of participation for each subject was approximately 34 days including screening and a 6-day in-clinic study confinement period.

Conditions

  • Tobacco Use

Interventions

OTHER

Test Product A

Use of Test Product A in controlled use and ad libitum use sessions

OTHER

Test Product B

Use of Test Product B in controlled use and ad libitum use sessions

OTHER

Test Product C

Use of Test Product C in controlled use and ad libitum use sessions

OTHER

Test Product D

Use of Test Product D in controlled use and ad libitum use sessions

OTHER

Test Product E

Use of Test Product E in controlled use and ad libitum use sessions

OTHER

Reference Product F: Subjects' OBMST

Use of Reference Product F in controlled use and ad libitum use sessions. The subjects' Own Brand Moist Smokeless Tobacco (OBMST) reference products used in this study were commercially available and had been reported by the subjects as the brands they usually consume.

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • Altria Client Services LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-06
Primary Completion
2023-05-10
Completion
2024-02-08

Countries

  • United States

Study Locations

More Related Trials

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 NCT06691386 on ClinicalTrials.gov