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Reduced HPHC Exposure in Cigarette Smokers Switching to P4M3 Gen. 2.0 Compared to Continuing Smoking, or Smoking Abstinence

NCT05487456 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2024-03-13

Study results available
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Summary

To demonstrate the reduction of Biomarkers of Exposure (BoExp) to selected harmful and potentially harmful constituents (HPHC) in smokers switching from cigarette (CIG) to P4M3, an Electronic Nicotine Delivery System (ENDS), compared to continuing cigarette smoking for 5 days.

Conditions

  • Nicotine
  • Vaping
  • Nicotine Vaping

Interventions

OTHER

P4M3 CA35

Ad libitum use of P4M3 with CA35 cartridges

OTHER

P4M3 CM35

Ad libitum use of P4M3 with CM35 cartridges

OTHER

CIG

Ad libitum use of subject's own preferred brand of cigarettes

OTHER

Smoking Abstinence

Abstention from cigarette smoking

Sponsors & Collaborators

  • Philip Morris Products S.A.

    lead INDUSTRY

Principal Investigators

  • Patrick Winiger, MD · Celerion

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
2022-07-15
Primary Completion
2022-08-31
Completion
2022-11-07

Countries

  • United Kingdom

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 NCT05487456 on ClinicalTrials.gov