A study to investigate nicotine effects on cognition, appetite & mood
Research type
Research Study
Full title
A randomised, crossover study to investigate the effect of a nicotine containing electronic cigarette or Modern Oral pouch on emotion, smoking urges, cognitive function and appetite in healthy adult smokers after a period of smoking abstinence.
IRAS ID
313760
Contact name
Helen Philpott
Contact email
Sponsor organisation
British American Tobacco (Investments) Limited.
Duration of Study in the UK
0 years, 8 months, 22 days
Research summary
The purpose of this study is to evaluate the effect of various types of nicotine containing products on different measures.
The main objectives of this study are:
- To evaluate whether a nicotine containing e-cigarette or modern oral (MO) nicotine pouch has any effect on emotion, smoking urges, cognitive function (specifically skills associated with attention and decision making) or appetite in regular smokers following a 12-hour period of not smoking compared to a conventional cigarette.
- To measure the levels of appetite hormones (a chemical messenger that controls different processes in the body) and nicotine in the blood, how these change over time and how these levels vary between an e-cigarette, MO pouch, and conventional cigarette.
In this study, participants will be required to use an e-cigarette product with an e-liquid (18 milligrams per millilitre (mg/mL) nicotine content), a conventional cigarette, an MO nicotine pouch (of 2 different nicotine strengths up to 4 mg) and complete a no product use session (total of 5 study sessions). During each session, prior to and after product use, participants will be asked to complete a series of different assessments to measure the effect of different nicotine containing products on the parameters as described above and blood samples will be taken to measure the levels of appetite hormones and nicotine levels.
The results from each of the study sessions will be compared to determine if there are any significant differences in any of the measures described above following use of each of the study products, in comparison with the conventional cigarette.
The study will be conducted in up to 40 healthy males and females who are regular smokers of at least 10 cigarettes per day and have done so for a minimum of 3 years and are familiar with (and/or dual users of) e-cigarettes.
REC name
Wales REC 1
REC reference
22/WA/0110
Date of REC Opinion
9 May 2022
REC opinion
Unfavourable Opinion