Study to measure the effect of nicotine on mood & appetite in smokers
Research type
Research Study
Full title
AN EXPLORATORY RANDOMISED CROSSOVER STUDY TO INVESTIGATE THE EFFECT OF NICOTINE ON APPETITE IN HEALTHY ADULT SMOKERS, WHO USE AN ELECTRONIC CIGARETTE, AFTER A PERIOD OF SMOKING ABSTINENCE
IRAS ID
289753
Contact name
Helen Philpott
Contact email
Sponsor organisation
British American Tobacco (Investments) Limited
ISRCTN Number
72435551
Duration of Study in the UK
0 years, 3 months, 20 days
Research summary
Research Summary
The overall purpose of this study is to determine if acute nicotine delivery (delivered via an eLiquid & eCigarette) can influence appetite (calorie consumption) in regular smokers following a 12-hour period of nicotine abstinence compared to a combustible cigarette.
This study also will investigate and compare the concentration of appetite hormones in the blood prior to and after use of different nicotine strength eLiquids and a commercially sourced cigarette. Additionally, the study will investigate if nicotine delivery (delivered via an eLiquid & eCigarette) can influence subjective mood and craving through the completion of a variety of questionnaires.
In this study, we will investigate the effects of 3 different strengths of nicotine eLiquid cartridges compared to a cigarette.
The study will comprise of a screening visit, 5 product use periods (each 1 day in duration with 1 overnight stay) and a post study follow up telephone call (5-7 days after the last product use period).
At each product use period, participants will be required to use one of the products in a randomised fashion (1 product per period with the exception of the first period).
For the period where participants use the commercial combustible cigarette, participants will be required to use the cigarette in an ad lib regimen i.e. smoking the cigarette as they like over a 5-minute period. For the study session where participants use the eLiquids, participants will be asked to use the product as they like over a period of 5 minutes.
Each study session will be separated by approximately 7 days.
Blood samples will be taken before and after each product use period to measure the concentration of appetite hormone in the blood and how this differs between the 4 products.
The study will be conducted in 40 healthy participants (males and females) at Simbec-Orion in Merthyr Tydfil, South Wales.
Summary of results
The overall purpose of this study was to determine if acute nicotine delivery (delivered via an eCigarette) can influence appetite (calorie consumption) in regular smokers following a 12-hour period of nicotine abstinence in comparison to a combustible cigarette.
This study also measured the levels of hormones associated with appetite in blood samples taken prior to and after use of different nicotine strength eCigarettes and a commercially sourced cigarette. Additionally, the study investigated if nicotine delivery (delivered via an eCigarette) influenced subjective mood and craving through the completion of a variety of questionnaires.
In this study, the effects on appetite hormones of 3 different strengths of nicotine e-cigarettes compared to a cigarette were evaluated. The data from this study will be used to support the development of these products in the future by the study sponsor. Each of the eLiquids evaluated during the study contained a different nicotine strength ranging between 0 mg/mL and 18 mg/mL nicotine content. The study comprised of a screening visit, 5 product use periods (each 1 day in duration with 1 overnight stay) and a post study follow up telephone call (5-7 days after the last product use). At each product use period, participants were required to use one of the products in a randomised fashion (1 product per product use period with the exception of the first product use session which was a baseline period with no product use).
For the product use session where participants used the commercial combustible cigarette, participants were required to use the cigarette in an ad lib regimen i.e. smoking the cigarette as they like over a 5-minute period. For the study session where participants used the eCigarette and associated eLiquids, participants were asked to use the product taking ad libitum puffs over a period of 5 minutes.
Within each product use session, a standard meal was provided to the participant 60 mins after product use following completion of each testing session. The participants were asked to eat until they were comfortably full. This meal was weighed pre and post meal session to identify the number of Kilocalories (Kcals) consumed following each product session. Each study session was separated by approximately 7 days.
With respect to the objectives of the study, the following outcomes were reported:
- With respect to effect on calorie consumption, the percentage of calories consumed was similar across all of the product use sessions, including the no product use session.
- The differences in the levels of ghrelin appetite hormone showed statistically significant differences between the 18 mg/mL eLiquid versus no product use, between the combustible cigarette versus no product use and between the 18 mg/mL eLiquid versus the 0 mg/mL eLiquid.
- The differences in the levels of insulin hormone showed statistically significant differences between the combustible cigarette versus the 18 mg/mL eLiquid.
- With respect to the assessment of smoking urges, there were statistically significant differences between use of all of the eLiquids/combustible cigarette versus no product use, in addition to significant differences between the 12 mg/mL & 18 mg/mL eLiquids versus the 0 mg/mL eLiquid and between the combustible cigarette versus the 0 mg/mL eLiquid.
- With respect to the assessment of subjective emotion, there were statistically significant differences in the average emotion score between use of all of the eLiquids/combustible cigarette versus no product use.
REC name
Wales REC 1
REC reference
20/WA/0276
Date of REC Opinion
11 Dec 2020
REC opinion
Further Information Favourable Opinion