A study of QuickMist Freshmint Mouthspray in e-cigarette users
Research type
Research Study
Full title
A Parallel group, Double-blind, Placebo-controlled, Randomized, Pharmacodynamic Study of QuickMist Freshmint Mouthspray in E-cigarette Users.
IRAS ID
1003033
Contact name
Temitope Adeloye
Contact email
Sponsor organisation
McNeil AB
Eudract number
2019-004741-33
Research summary
Summary of Research
This is a study of QuickMist Freshmint mouthspray (the study medicine), a marketed
medicine that can help smokers to stop smoking. We’re doing this study to find out if
QuickMist Freshmint mouthspray could also help e-cigarette users quit vaping.
We’ll test repeated doses of the study medicine over 13 h in up to 266 healthy vapers,
aged 19–55 years. We aim to find out how well it helps reduce urges to vape in regular ecigarette
users. We’ll also measure blood levels of nicotine after volunteers use their
usual e-cigarette, compared to after they use the study medicine.
Participants will have 1 study session, and stay on the ward for 1 day and 1 night.
A pharmaceutical company (McNeil AB) is funding the study.
The study will take place at 1 centre in London.Summary of Results
Why did we do the study?This was a study of QuickMist Freshmint mouthspray (the study medicine), a marketed medicine that can help smokers to stop smoking. We did this study to find out if the study medicine could also help e-cigarette users quit vaping.
We tested repeated doses of the study medicine in healthy vapers to find out how well it helped reduce urges to vape in regular e-cigarette users. We also compared blood levels of nicotine after volunteers used their usual e-cigarette with those after they’d used the study medicine.Who organised the study and when did it take place?
The doctors and support staff of HMR, London organised the study. A pharmaceutical company – McNeil AB, Sweden (the ‘sponsor’) – paid for the study.
The study took place at HMR (London) from 29 September 2020 until 20 November 2021. We stopped the study earlier than planned because recruitment of volunteers was difficult.Who took part in the study and what treatments did they take?
216 healthy vapers, aged 18–53 years, took part in the study. They took repeated doses of QuickMist mouthspray or dummy mouthspray (placebo) over 13 hours.
What were the results of the study?
Side effects
Side effects are unwanted medical events (such as headache) that happen during the study and are reported because the study doctor believes the side effects may have been related to the study medicine. In this study, we found out the following.
• The study medicine was safe and well tolerated.
• There were no serious side effects – those are side effects that are life threatening or required someone to go to hospital • Not all people in the study had side effects that the study doctor considered to have been caused by the study medicine.
• The most common side effects (reported by more than 1 out of 20 people [5%]) were: throat irritation, hiccups, headaches, feeling sick, indigestion and a mouth discomfort.
• More people had side effects after taking the study medicine than after taking placebo.Other results
• The study medicine worked significantly better than placebo at relieving the urge to vape, both during the 2 hours after a single dose and while using as often as needed for the next 11 hours.
• The study medicine acted quickly and had lasting effect: it significantly reduced urges to vape from 30 sec after the first use, and continued to do so for the next 2 h without taking another dose • Blood levels of nicotine after using the study medicine as often as needed for 11 hours were lower than those after vaping.
• Most volunteers felt less stressed, irritable and distracted by cravings during the study treatment than they would normally feel while trying to give up vaping, but there was no important difference between the study medicine and placebo.
• Most volunteers, regardless of whether they took the study medicine or placebo, felt the study treatment was a convenient way to relieve cravings, but did not feel that the study medicine would be suitable for all their cravings.How has the study helped e-cigarette users and researchers?
We don’t yet know all the risks associated with e-cigarette use (vaping), and a lot of vapers want to stop using e-cigarettes and nicotine completely. The results from this study have shown that the study medicine could help e-cigarette users quit vaping by relieving their vaping cravings.
Are there plans for further studies?
Further studies of QuickMist Freshmint mouthspray (the study medicine) are planned.
REC name
London - Westminster Research Ethics Committee
REC reference
20/LO/0604
Date of REC Opinion
12 May 2020
REC opinion
Favourable Opinion