Nicotine PK & PD study of vibrating mesh device compared to cigarettes
Research type
Research Study
Full title
A single-center, randomized, controlled, partially blinded, crossover study to evaluate the nicotine pharmacokinetics and pharmacodynamics of two variants of Vibrating Mesh 1.0 (VM 1.0), a nicotine-containing aerosol generator, compared to cigarettes in adult current smokers
IRAS ID
356826
Contact name
Devinda Weeraratne
Contact email
Sponsor organisation
Philip Morris Products S.A
Clinicaltrials.gov Identifier
NCT07135648.
Duration of Study in the UK
0 years, 0 months, 28 days
Research summary
The study aims to demonstrate investigational products used in this study are two variants of Vibrating Mesh 1.0 (VM 1.0) which is a novel nicotine-containing aerosol generator and a conventional cigarette. The two variants of VM1.0 are known as VM16 and VM32 and differ in nicotine content. VM16 contains a liquid with nicotine concentration of 1.6% while VM32 contains a liquid with nicotine concentration of 3.2%.The VM 1.0 Cartridge contains a water-based, nicotine-containing liquid which is aerosolized by a porous, vibrating membrane without heating. VM 1.0 technology delivers a nicotine-containing aerosol for inhalation. The VM 1.0 device is puff-activated (puff-on-demand) and rechargeable. The Cartridge contains the liquid and is replaceable.
The comparator product is commercial cigarettes. Participants will provide their own usual brand of commercially available cigarettes.
The main purpose of this clinical study is to find out how much nicotine is absorbed after using the VM16 and VM32 study products in a fixed smoking regimen compared to cigarette smoking.
The other purposes of this clinical study are to:
Learn about product craving, product liking, nicotine content satisfaction and product experience of the study products in the clinical study.
Measure the amounts of nicotine delivered from VM16 and VM32 when used with a fixed puff regimen.
Describe usage behaviour of VM16 and VM32 when used with a fixed puffing regimen.
Learn about the safety of investigational products in the clinical study.REC name
Wales REC 1
REC reference
25/WA/0157
Date of REC Opinion
18 Jun 2025
REC opinion
Further Information Favourable Opinion