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CSD231005 Nicotine Pouch Biomarkers of Exposure

NCT06303115 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-04-11

No results posted yet for this study

Summary

This will be a multi center open label, randomized, controlled, switching parallel-group study designed to assess changes in select biomarkers of exposure (BoE) in generally healthy smokers following a 5 day in-clinic switch to use of nicotine Pouch investigational products (IPs) compared to continued usual brand (UB) cigarette smoking or smoking abstinence.

Conditions

  • Tobacco Use
  • Smoking

Interventions

OTHER

Nicotine Pouch P1312914, 4 mg nicotine

P1312914 pouch product

OTHER

Nicotine Pouch P1312915, 8 mg nicotine

P1312915 pouch product

OTHER

Nicotine Pouch P1013215, 8 mg nicotine

P1013215 pouch product

OTHER

Nicotine Pouch P1013218, 10 mg nicotine

P1013218 pouch product

OTHER

Nicotine Pouch P1012919, 12 mg nicotine

P1012919 pouch product

OTHER

Smoking Abstinence

No tobacco/nicotine

OTHER

Continued UB cigarette smoking

Usual Brand Cigarette

Sponsors & Collaborators

  • RAI Services Company

    lead INDUSTRY

Principal Investigators

  • Brian Keyser, PhD · Reynolds American

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-08-22
Primary Completion
2025-01-15
Completion
2025-01-15

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 NCT06303115 on ClinicalTrials.gov