A study to evaluate nicotine in two e-liquid variants
Research type
Research Study
Full title
A Single-centre, Single-Blinded, Randomized, Crossover Study to Assess the Nicotine Pharmacokinetic Profile Following Use of two Variants of Logic Compact in Adult Healthy Electronic Cigarette Users
IRAS ID
312287
Contact name
Helen Philpott
Contact email
Sponsor organisation
JT International SA
ISRCTN Number
ISRCTN97168882
Duration of Study in the UK
0 years, 1 months, 14 days
Research summary
Research Summary
The purpose of this study is to evaluate two different variations of nicotine containing e-liquids (tobacco flavour pods) delivered by the Logic Compact e-cigarette device (both device and pods are commercially available products in the UK).
The main objectives of this study are as follows:
To measure the levels of nicotine in the blood following single and multiple use of two different types of Logic Compact e-liquids (nicotine strength 18 milligram per millilitre (mg/mL) one liquid with nicotine salts and one without nicotine salts).
To measure the differences between the two different types of the Logic Compact e-liquid by evaluating different subjective measures i.e., completion of specific questionnaires around product usage such as intent to use, product satisfaction etc.
To determine the amount of nicotine delivered into the body following single and multiple use sessions of both types of e-liquids (one containing nicotine salts and one without nicotine salts) and to assess if there are any variations in the amount of nicotine delivered.
To provide general safety information for the two types of Logic Compact e-liquids.
The study will enrol up to 20 participants who are regular users of nicotine containing products and will comprise of two product use periods; each session evaluating one of the variants of the Logic Compact e-liquids. During each period, participants will be asked to complete two use sessions per day, one session where participants will use the product for a period of 5 minutes and a second use session where participants will be required to use the product for a period of up to 6 hours. During each session, blood samples will be taken to measure the levels of nicotine in the blood. In addition, participants will be asked to complete a series of questionnaires to assess different measures including product satisfaction and intent for product usage.
Summary of Results
The purpose of this study was to evaluate two different variations of nicotine containing e-liquids (tobacco flavoured pods) delivered by the Logic Compact e-cigarette device.
The main objectives of this study were as follows:
- To measure the levels of nicotine in the blood following single and multiple use of two different types of Logic Compact e-liquids (nicotine strength 18 milligram per millilitre (mg/mL) one liquid with nicotine salts and one without nicotine salts).
- To measure the differences between the two different types of the Logic Compact e-liquid by evaluating different subjective measures i.e., completion of specific questionnaires around product usage such as intent to use, product satisfaction etc.
- To determine the amount of nicotine delivered into the body following single and multiple use sessions of both types of e-liquids (one containing nicotine salts and one without nicotine salts).
- To provide general safety information for the two types of Logic Compact e-liquids.
In this study, participants were required to use two different variants of the Logic Compact e-liquids (Tobacco and Intense Amber Tobacco flavour, 18 mg/mL nicotine content) which are both commercially available products in the UK.
The study comprised of two product use periods; each session evaluating one of the two variants of the Logic Compact e-liquids. During each period, participants were asked to complete two use sessions per day, one session where participants used the product for a period of 5 minutes and a second use session where participants used the product as they felt necessary for a period of up to 6 hours. During each session, blood samples were taken to measure the levels of nicotine in the blood and how these changed over time. In addition, participants were asked to complete a series of questionnaires in order to assess different measures such as product satisfaction etc and the intent to use the products again.
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:
- With respect to the levels of nicotine in the blood following the 5-minute single use session, the highest level of nicotine recorded for the Logic Compact Tobacco flavour pods (e-liquid without nicotine salts) was 9.17 ng/mL and 13.2 ng/mL for the Logic Compact Intense Amber Tobacco flavour pods (e-liquid containing nicotine salts). Following the 6-hour multiple use session, the highest level of nicotine recorded for the Logic Compact Tobacco flavour pods (e-liquid without nicotine salts) was 8.73 ng/mL and 12.5 ng/mL for the Logic Compact Intense Amber Tobacco flavour pods (e-liquid containing nicotine salts).
- In addition, the time taken for the levels in the blood to reach their highest level in the 5-minute single use session was 7.5 minutes for the Logic Compact Tobacco flavour pods (e-liquid without nicotine salts) and 5 minutes for the Logic Compact Intense Amber Tobacco flavour pods (e-liquid containing nicotine salts).
- With respect to the calculated theoretical amount of nicotine consumption following the 5-minute single use session, the calculated value for the Logic Compact Tobacco flavour pods (e-liquid without nicotine salts) was 1.1097 mg and 1.3275 mg for the Logic Compact Intense Amber Tobacco flavour pods (e-liquid containing nicotine salts). Following the 6-hour multiple use session, the calculated theoretical amount of nicotine consumption for the Logic Compact Tobacco flavour pods (e-liquid without nicotine salts) was 7.3158 mg and 8.7948 mg for the Logic Compact Intense Amber Tobacco flavour pods (e-liquid containing nicotine salts).
- With respect to the measurement of the subjective effects e.g., intent to use the product again, product satisfaction, there were no marked differences observed for either of the products following the 5-minute single use session and 6-hour multiple use session for each product.
- With respect to the safety evaluations for the products, there were no safety concerns identified for either of the products during the study. There were only 5 mild side effects reported by 4 participants across the whole study, with one effect reported prior to product use. Only one of the reported effects (headache) was considered to be possibly related to the product use and all effects with the exception of one resolved within less than one day. There were also no significant findings identified in any of the other safety assessments i.e., vital signs, ECG, physical examination and safety laboratory testing.
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
22/WA/0061
Date of REC Opinion
8 Mar 2022
REC opinion
Favourable Opinion