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

  devinda.weeraratne@celerion.com

• 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

  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.

  Summary of Results
  This study examined how much nicotine people absorb when using a new inhalation device called Vibrating Mesh (VM) 1.0, compared with smoking a regular cigarette. Two variants of the device were tested: VM16, which contains a lower nicotine concentration, and VM32, which contains a higher nicotine concentration. Both devices were used in the same way, with participants taking 10 puffs spaced about 30 seconds apart. The study involved 24 adult smokers who had been smoking cigarettes for at least 12 months.
  Overall, both VM devices delivered much less nicotine than smoking a cigarette. VM16 delivered a lower amount of nicotine than VM32. Nicotine from cigarettes smoking also reached the bloodstream faster than nicotine delivered from either VM device. On average, nicotine levels peaked about 6 minutes after smoking a cigarette, compared with about 8 minutes after using VM16 and VM32. This timing still indicates that nicotine from the VM devices was absorbed through the lungs, but more slowly and in smaller amounts than from cigarettes smoking.
  According to participants’ self-reported craving, based on VAS Craving, all products reduced craving for cigarettes smoking shortly after use, but the effect was strongest with cigarette smoking. Both VM16 and VM32 reduced cravings to a lesser extent, and their effects were similar to each other. Overall, according to the answers given by participants to Questionnaire on Smoking Urges (QSU) the VM devices did not reduce the urge to smoke as effectively as cigarettes.
  Participants rated both VM16 and VM32 similarly in terms of liking but rated their usual cigarettes more favourably. Although the perceived nicotine strength was reported to be similar across products, VM16 and VM32 were considered less satisfying overall.
  Participants’ puffing behaviour varied widely, which is likely related to their lack of experience with electronic or vapor products.
  From a safety perspective, no serious side effects were reported during the study. Only two mild adverse events occurred, and neither was considered related to the study products. No clinically meaningful changes were observed in physical examinations, laboratory tests, heart monitoring, or lung function. In summary, the Vibrating Mesh 1.0 variants were able to deliver nicotine through inhalation but resulted in lower and slower nicotine absorption than cigarettes, reduced cigarette cravings less effectively, and were rated as less satisfying by participants, while showing no short‑term safety concerns under the conditions of this study.
  

• REC name

  Wales REC 1

• REC reference

  25/WA/0157

• Date of REC Opinion

  18 Jun 2025

• REC opinion

  Further Information Favourable Opinion