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Study to Evaluate Changes in Smokers Using on!® Nicotine Pouches

NCT05664672 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2024-12-09

Study results available
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Summary

The purpose of this study is to generate evidence regarding the extent of reduction in exposure to selected HPHCs in adult smokers switching to on!® NPs. The study intends to determine changes in exposure to selected HPHCs by measuring biomarkers in adult smokers who completely switch from smoking to use of on!® NP compared to those who continue smoking cigarettes or stop using all tobacco products.

Conditions

  • Tobacco Use

Interventions

OTHER

OTDN Product 1

Mint on!® 2 mg nicotine pouches

OTHER

OTDN Product 2

Mint on!® 4 mg nicotine pouches

OTHER

OTDN Product 3

Mint on!® 8 mg nicotine pouches

OTHER

No Tobacco

subjects completely stop all tobacco product usage for 7 days

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • Altria Client Services LLC

    lead INDUSTRY

Principal Investigators

  • William J Howitt, MD · QPS Holdings LLC

  • William Smith, MD · NOCCR

  • Mark Adams, MD · CKRA

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-05-11
Primary Completion
2021-08-31
Completion
2021-08-31

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 NCT05664672 on ClinicalTrials.gov