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E-Cigarette
Product Sequence 5 for Vaping
N/A
Waitlist Available
Led By Melanie Fein, MD
Research Sponsored by Philip Morris Products S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured from start of product use to 2 minutes, to 4 minutes, to 10 hours, and then to time of last quantifiable concentration
Awards & highlights
Study 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.
Eligible Conditions
- Vaping
- Nicotine
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured from start of product use to 2 minutes, to 4 minutes, to 10 hours, and then to time of last quantifiable concentration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured from start of product use to 2 minutes, to 4 minutes, to 10 hours, and then to time of last quantifiable concentration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area under the background-corrected concentration-time curve (AUC)
Background-corrected maximum plasma concentration [Cmax]
Background-corrected time to the maximum concentration [Tmax]
+1 moreTrial Design
6Treatment groups
Active Control
Group I: Product Sequence 5Active Control3 Interventions
After at least 12 hours of abstinence from the use of any nicotine/tobacco containing products (referred to as nicotine wash-out), subjects will smoke a cigarette or use one of the e-liquid variants with P4M3 Gen 2.0 according to randomized product use sequence ad libitum for 6 minutes (± 30 seconds).
CM35 on Day 1; Cig on Day 2; CA35 on Day 3
Group II: Product Sequence 1Active Control3 Interventions
After at least 12 hours of abstinence from the use of any nicotine/tobacco containing products (referred to as nicotine wash-out), subjects will smoke a cigarette or use one of the e-liquid variants with P4M3 Gen 2.0 according to randomized product use sequence ad libitum for 6 minutes (± 30 seconds).
CA35 on Day 1; Cig on Day 2; CM35 on Day 3
Group III: Product Sequence 2Active Control3 Interventions
After at least 12 hours of abstinence from the use of any nicotine/tobacco containing products (referred to as nicotine wash-out), subjects will smoke a cigarette or use one of the e-liquid variants with P4M3 Gen 2.0 according to randomized product use sequence ad libitum for 6 minutes (± 30 seconds).
CA35 on Day 1; CM35 on Day 2; Cig on Day 3
Group IV: Product Sequence 3Active Control3 Interventions
After at least 12 hours of abstinence from the use of any nicotine/tobacco containing products (referred to as nicotine wash-out), subjects will smoke a cigarette or use one of the e-liquid variants with P4M3 Gen 2.0 according to randomized product use sequence ad libitum for 6 minutes (± 30 seconds).
Cig on Day 1; CA35 on Day 2; CM35 on Day 3
Group V: Product Sequence 4Active Control3 Interventions
After at least 12 hours of abstinence from the use of any nicotine/tobacco containing products (referred to as nicotine wash-out), subjects will smoke a cigarette or use one of the e-liquid variants with P4M3 Gen 2.0 according to randomized product use sequence ad libitum for 6 minutes (± 30 seconds).
Cig on Day 1; CM35 on Day 2; CA35 on Day 3
Group VI: Product Sequence 6Active Control3 Interventions
After at least 12 hours of abstinence from the use of any nicotine/tobacco containing products (referred to as nicotine wash-out), subjects will smoke a cigarette or use one of the e-liquid variants with P4M3 Gen 2.0 according to randomized product use sequence ad libitum for 6 minutes (± 30 seconds).
CM35 on Day 1; CA35 on Day 2; Cig on Day 3
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Who is running the clinical trial?
Philip Morris Products S.A.Lead Sponsor
46 Previous Clinical Trials
31,847 Total Patients Enrolled
2 Trials studying Vaping
89 Patients Enrolled for Vaping
Melanie Fein, MDPrincipal InvestigatorHigh Point Clinical Trials Center (HPCTC)
4 Previous Clinical Trials
413 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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