Reduced HPHC Exposure in Cigarette Smokers Switching to P4M3 Gen. 2.0 Compared to Continuing Smoking, or Smoking Abstinence
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|ClinicalTrials.gov Identifier: NCT05487456|
Recruitment Status : Completed
First Posted : August 4, 2022
Last Update Posted : January 26, 2023
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Vaping Nicotine Vaping||Other: P4M3 CA35 Other: P4M3 CM35 Other: CIG Other: Smoking Abstinence||Not Applicable|
This clinical study aims to demonstrate the reduction of BoExp to selected HPHC in smokers switching from CIG to two flavor variants of P4M3 as compared to smokers continuing smoking CIG, or to smoking abstinence (SA).
A reduction of exposure to HPHC from CIG smoke is expected to diminish the health risk of nicotine consumption if switching completely to ENDS.
The data collected in this study in confinement will provide information on exposure reductions achievable in a well-controlled environment with full control on daily P4M3/CIG consumption and compared to SA.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Controlled, Open-label, 4-arm Parallel Group Study to Demonstrate Reductions in Exposure to Selected Harmful and Potentially Harmful Constituents (HPHC) in Healthy Smokers Switching to 2 Variants of P4M3 Gen 2.0, an Electronic Nicotine Delivery System (ENDS), Compared to Continuing Smoking Cigarettes, or Abstaining From Smoking, for 5 Days in a Confinement Setting|
|Actual Study Start Date :||July 15, 2022|
|Actual Primary Completion Date :||September 2, 2022|
|Actual Study Completion Date :||November 7, 2022|
Active Comparator: P4M3 CA35
Ad libitum use of P4M3 using CA35 Cartridges
Other: P4M3 CA35
Ad libitum use of P4M3 with CA35 cartridges
Other Name: P4M3 "Classic Auburn" 3.5% nicotine (CA35)
Active Comparator: P4M3 CM35
Ad libitum use of P4M3 using CM35 Cartridges
Other: P4M3 CM35
Ad libitum use of P4M3 with CM35 cartridges
Other Name: P4M3 "Classic Menthol" 3.5% nicotine (CM35)
Active Comparator: Cigarette
Ad libitum use of subject's own preferred CIG brand
Ad libitum use of subject's own preferred brand of cigarettes
Other Name: Cigarette
Active Comparator: Smoking Abstinence
Other: Smoking Abstinence
Abstention from cigarette smoking
- 3-HPMA [ Time Frame: From baseline to 5 days ]To measure change in 3-hydroxypropyl mercapturic acid (3-HPMA), which is a biomarker of exposure to Acrolein.
- 2-CyEMA [ Time Frame: From baseline to 5 days ]To measure change in 2-cyanoethyl mercapturic acid (2-CyEMA), which is a biomarker of exposure to Acrylonitrile.
- Total NNAL [ Time Frame: From baseline to 5 days ]To measure change in Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL), which is a biomarker of exposure to 4-(methylnitrosamino)-1-(3- pyridyl)-1-butanone (NNK).
- COHb [ Time Frame: From baseline to 5 days ]To measure change in carboxyhemoglobin (COHb), which is a biomarker of exposure to Carbon monoxide (CO).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05487456
|Belfast, United Kingdom|
|Principal Investigator:||Patrick Winiger, MD||Celerion|