Vaping Clinical Trial
Official title:
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
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05037656 -
Testing a School-Based E-cigarette, Tobacco, and Betel (Areca) Nut Use Prevention Curriculum for Guam Youths
|
N/A | |
Recruiting |
NCT05454267 -
Early Detection of Vaping-related Vascular Diseases
|
||
Enrolling by invitation |
NCT04678245 -
Network Intervention to Prevent Vaping
|
N/A | |
Recruiting |
NCT06297005 -
The Impact of E-cigarettes During Pregnancy on Childhood Health Outcomes Study
|
||
Not yet recruiting |
NCT05999383 -
Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration
|
Phase 2 | |
Completed |
NCT04522362 -
Modeling Stress-precipitated Vaping Behavior
|
N/A | |
Completed |
NCT04054765 -
A Virtual Reality Videogame for E-cigarette Prevention in Teens
|
N/A | |
Recruiting |
NCT06291597 -
Vaping Adverse Lung and Heart Events Cohort
|
||
Active, not recruiting |
NCT04919590 -
Text Message Quit Vaping Intervention for Adolescents
|
N/A | |
Completed |
NCT04568395 -
Acute Effects of TCIG vs ECIG in PLWH
|
N/A | |
Completed |
NCT04707911 -
Social Media Intervention to Stop Nicotine and Cannabis Vaping Among Adolescents
|
N/A | |
Withdrawn |
NCT04340700 -
Characterization of the Pharmacodynamic Response to Vaped THC
|
Phase 3 | |
Not yet recruiting |
NCT06335329 -
Point-of-Care Ultrasound (POCUS) Findings and Impact on Vaping
|
N/A | |
Completed |
NCT06433466 -
Influencer Marketing: a Survey-based Experiment
|
N/A | |
Active, not recruiting |
NCT05488743 -
Smoking Prevention Program in Poland
|
||
Terminated |
NCT05240027 -
To Vape or Not to Vape
|
N/A | |
Recruiting |
NCT04661683 -
Secondhand Effects of Hookah (i.e., Waterpipe) Smoke and Aerosol
|
N/A | |
Completed |
NCT04450537 -
PACE Vape Messaging Study
|
N/A | |
Active, not recruiting |
NCT05367492 -
Varenicline for Nicotine Vaping Cessation in Adolescents
|
Phase 4 | |
Completed |
NCT04879225 -
Menthol and Mint Experimental Tobacco Marketplace (ETM) Study
|
N/A |