Study to measure effect of nicotine on cognitive function in smokers
Research type
Research Study
Full title
An exploratory, randomised, crossover study to investigate the effect of nicotine on cognitive function in healthy adult smokers who use an electronic cigarette, after a period of smoking abstinence.
IRAS ID
292871
Contact name
Helen Philpott
Contact email
Sponsor organisation
British American Tobacco (Investments) Limited.
ISRCTN Number
ISRCTN35376793
Duration of Study in the UK
0 years, 3 months, 22 days
Research summary
Summary of Research
The purpose of this study is to evaluate eLiquids of varying nicotine strengths in comparison with a conventional cigarette and following no nicotine use.
The main objectives of this study are as follows:
- To evaluate as to whether nicotine delivered via an eCigarette has any effect on cognitive function (specifically skills associated with memory, attention and decision making) compared to a combustible cigarette.- To evaluate as to whether nicotine delivered via an eCigarette can influence mood and cravings in regular smokers following a 12-hour period of not smoking compared to a combustible cigarette.
In this study, participants will be required to use an eCigarette product with 3 different nicotine strength eLiquids (Golden Tobacco flavour, up to 18 mg/mL – all commercially available products), a conventional cigarette and complete a session with no nicotine use (total of 5 study sessions).
During each session, prior to and after product use, participants will be asked to complete a series of cognitive tests which will test different aspects of their skills e.g. sustained attention abilities, memory testing, response speeds etc using a series of specialised computer software testing which specifically measures these aspects of cognitive function.
The results from each of the study sessions will be compared to determine if there are any significant differences in cognitive performance following use of each of the study products, in comparison with the conventional cigarette and following no nicotine use. Furthermore, the overall effect of nicotine on mood and cravings will also be evaluated.
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) eCigarettes.
Summary of Results
The purpose of this study was to evaluate eLiquids of varying nicotine strengths in comparison with a conventional cigarette and following no nicotine use.
The main objectives of this study were as follows:
• To evaluate as to whether nicotine delivered via an eCigarette had any effect on cognitive function (specifically skills associated with memory, attention and decision making) compared to a combustible cigarette.
• To evaluate as to whether nicotine delivered via an eCigarette influenced mood and cravings in regular smokers following a 12-hour period of not smoking compared to a combustible cigarette.
In this study, participants were required to use an eCigarette product with 3 different nicotine strength eLiquids (Golden Tobacco flavour, up to 18 mg/mL – all commercially available products), a conventional cigarette and complete a session with no nicotine use (total of 5 study sessions). During each session, prior to and after product use, participants were asked to complete a series of cognitive tests tested different aspects of their skills e.g., sustained attention abilities, memory testing, response speeds etc. using a series of specialised computer software testing which specifically measured these aspects of cognitive function.
The results from each of the study sessions were compared to determine if there were any significant differences in cognitive performance following use of each of the study products, in comparison with the conventional cigarette and following no nicotine use. Furthermore, the overall effect of nicotine on mood and cravings was evaluated.
The purpose of the data generated in this study was to provide further information about nicotine containing products to add to the growing body of data being generated for these types of products.With respect to the objectives of the study, the following outcomes were reported:
• Nicotine delivery had limited effects on cognitive function (sustained attention, working memory, episodic memory and executive function).
• When comparing the nicotine containing eLiquid products versus a combustible cigarette, there were no significant differences in the outcomes generated from the various cognitive tests performed.
• When comparing the nicotine containing eLiquid products versus no product use (i.e., total nicotine abstinence), there were some noted significant increases in cognitive scores associated with testing elements of sustained attention, indicating a potential improvement in this area of cognitive function. There were no differences observed in any other cognitive testing measures performed.
• In regard to smoking urges, nicotine products reduced smoking urges in seemingly a dose dependent manner; for Factor 1 scores, the cigarette performed significantly better than the nicotine containing e-cigarettes, which, in turn, also performed significantly better than no product.
• With respect to mood assessment, it was observed that there were higher average mood scores amongst participants using any of the nicotine containing products during the study versus no nicotine use, indicating a potential improvement in mood following nicotine use.
• With respect to safety evaluation, it was observed that all products evaluated in the study were safe and well tolerated. All of the reported side effects in the study were mild to moderate in severity and resolved before the study completed and were considered as not related to the study products. In addition, the reported effects were considered to be similar across all of the products evaluated.
In summary, the data gathered during the study was considered sufficient to meet the objectives of the study and warrant further investigations of the study products.
REC name
Wales REC 1
REC reference
21/WA/0095
Date of REC Opinion
20 Apr 2021
REC opinion
Further Information Favourable Opinion