Loading clinical trials...

Nicotine Pharmacokinetics Following Use of the P4M3 Gen 2.0 E-Cigarette Compared to Smoking Cigarettes | Clinical Trials | Clareo Health

COMPLETEDNA

Nicotine Pharmacokinetics Following Use of the P4M3 Gen 2.0 E-Cigarette Compared to Smoking Cigarettes

A Single-center, Randomized, Controlled, Open-label, Cross-over Study in Healthy Subjects to Investigate the Nicotine Pharmacokinetic Profiles of 2 Variants of P4M3 Gen 2.0, an Electronic Nicotine Delivery System, Compared to Cigarettes

NCT05383508•Philip Morris Products S.A.

View on ClinicalTrials.gov

Summary

This is a single-center, randomized, controlled, open-label, cross-over study with healthy adult smokers. The study will investigate the nicotine pharmacokinetic (PK) profiles of two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette, compared to smoking combustible cigarettes. In addition, pharmacodynamic (PD) effects (subjective effects and related behavioral assessments), will be evaluated to provide further insights on product evaluation, craving, liking, puffing topography. The study will be conducted with three periods and six sequences in a cross-over design. This study is exploratory and there is no pre-specified hypothesis to be tested.

Detailed Description

The purpose of the study is to evaluate the nicotine pharmacokinetics (PK) profiles of two e-liquid variants used with the P4M3 Gen 2.0 e-cigarette versus cigarettes following a six minutes ad libitum use period. In addition, pharmacodynamic effects (PD), including subjective effects and related behavioral assessments, as well as human puffing topography (HPT) will be evaluated, to provide further insights on P4M3 Gen 2.0 product acceptance and product use. Safety will be assessed throughout the study. The aim is to evaluate if P4M3 Gen 2.0 can provide an acceptable alternative to smoking cigarettes in terms of both, nicotine delivery and sensorial satisfaction for current adult smokers who would otherwise continue smoking cigarettes.

Eligibility

Age

24 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subject has signed the ICF and is able to understand the information provided in the ICF.
•Subject has smoked continuously for at least the last 3 years prior to the Screening visit.
•Subject has smoked ≥ 10 commercially available cigarettes per day for 4 weeks prior to Screening Visit and Admission.
•Subject does not plan to quit smoking cigarettes or using other nicotine or tobacco containing products in the next 3 months.
•Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the Screening period.

Exclusion Criteria

•As per the Investigator's judgment, the subject cannot participate in the study for any reason other than medical.
•Subject has donated or received whole blood or blood products within 30 days prior to Screening Visit.
•BMI \< 18.5 kg/m2 or \> 35.0 kg/m2.
•Subject has received medication within 14 days or within 5 half-lives of the drug prior to Admission (whichever is longer), which has an impact on CYP2A6 activity.
•Subject has a positive serology test for HIV 1/2, Hepatitis B or Hepatitis C.
•Subject has a history of alcohol abuse that could interfere with the subject's participation in study.
•Subject has a positive urine drug test.
•Subject has a positive alcohol breath test.
•Subject has participated in another clinical study within 30 days prior to the Screening Visit.
•Subject is pregnant (does not have negative pregnancy tests at Screening Visit and at Admission) or is breastfeeding.
+1 more criteria

Locations (1)

High Point Clinical Trials Center (HPCTC)

High Point, North Carolina, United States

Key Dates

Start Date

April 28, 2022

Primary Completion Date

June 29, 2022

Completion Date

August 25, 2022

Last Updated

April 26, 2024

Enrollment

ACTUAL participants

Conditions

Nicotine VapingNicotineVaping

Interventions

CA35

OTHER

CM35

OTHER

Cig

OTHER

Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging

NCT01036581

Drug AbuseNicotine Dependence

View study

RECRUITING

Vape Use Among Younger & Older Smokers

NCT07214168

Smoking CigaretteSmoking Behaviors+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 26, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Nicotine Pharmacokinetics Following Use of the P4M3 Gen 2.0 E-Cigarette Compared to Smoking Cigarettes

Inclusion Criteria

Exclusion Criteria

Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging

Vape Use Among Younger & Older Smokers

Temporal Interference Methods for Addiction Treatment

Cannabis THC Potency, Metabolism, and Cognitive Impairment in Young Adults

Behavioral Intervention for Youth to Promote Vaping Cessation

tDCS Plus Varenicline for Smoking Cessation