A study to assess if nicotine delivered via an e-cigarette can have an effect on cognitive function in healthy adult smokers
- Conditions
- Cigarette smokingNot Applicable
- Registration Number
- ISRCTN35376793
- Lead Sponsor
- British American Tobacco (United Kingdom)
- Brief Summary
2022 Protocol article in https://dx.doi.org/10.18203/2349-3259.ijct20221114 (added 18/08/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
1. Healthy male or female subject, between 25 and 45 years of age, inclusive.
2. Female subject of childbearing potential willing to use a highly effective method of contraception or 2 effective methods of contraception if applicable (unless of non-childbearing potential or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) from screening until the post study follow up phone call.
3. Female subject of non-childbearing potential. For the purposes of this study, this is defined as the subject being amenorrhoeic for at least 12 consecutive months or at least 4 months post-surgical sterilisation (including bilateral fallopian tube ligation or bilateral oophorectomy with or without hysterectomy; documentation of the procedure is required).
4. Female subject with a negative pregnancy test at Screening who is not breastfeeding or lactating.
5. Female subject of menopausal status confirmed by demonstrating at Screening that the serum level of the follicle stimulating hormone (FSH) falls within the respective pathology reference range. In the event a subject's menopausal status has been clearly established (for example, the subject indicates she has been amenorrhoeic for 10 years, confirmed by medical history, etc), but serum FSH levels are not consistent with a postmenopausal status, determination of the subject’s eligibility to be included in the study will be at the Investigator’s discretion following consultation with the Sponsor.
6. Subject with a body mass index (BMI) of 18.5-29.9 kg/m2; BMI = body weight (kg) / [height (m)]2.
7. Subject with a negative urinary drugs of abuse (DOA) screen (including alcohol) test results, determined within 28 days before the first study session (N.B.: A positive test result may be repeated at the Investigator’s discretion).
8. No clinically significant abnormalities in vital signs (blood pressure, pulse rate, oral temperature, respiration rate) determined within 28 days before the first study session.
9. Subjects who are self-reported current daily users of conventional factory-made cigarettes and/or roll your own cigarettes (a minimum of 10 cigarettes per day) for at least 3 years. Subjects should also be familiar with using e-cigarettes (i.e. have used e-cigarettes over a period of greater than 1 month within the last 2 years) and can tolerate an e-liquid concentration of up to 18mg/mL prior to the screening visit. 10. Product use status will be confirmed with a urinary cotinine level of =200 ng/mL and product use history questionnaire at screening. 10. Subjects who are willing to consume the study standardised breakfast.
11. Subjects who are willing to comply with the study protocol.
12. Subject must be available to complete the study (including all follow up visits).
13. Subject must satisfy an Investigator about his/her fitness to participate in the study.
14. Subject must provide written informed consent to participate in the study.
15. Subjects who do not have any clinically significant cognitive deficit disorders as assessed by a Medical professional and as determined by taking medical history.
16. Subjects who are willing to use a Golden Tobacco flavoured e-cigarette.
1. Subjects who have an acute illness (e.g. upper respiratory tract infection, viral infection, etc) requiring treatment within 4 weeks prior to Screening or on admission.
2. Use of any medications or substances (other than tobacco), including vitamins, herbal and dietary supplements which are known to be strong inducers or inhibitors of cytochrome P450 (CYP) enzymes within 14 days or 5 half-lives (whichever is longer) prior to Screening.
3. Subjects who are self-reported non-inhalers (smokers/vapers who draw smoke/aerosol from the cigarette/e-cigarette into the mouth and throat but who do not inhale).
4. Subjects who, prior to enrolment, are planning to quit/alter smoking/vaping usage within the duration of the study (to follow-up telephone call). All subjects will be informed that they are free to quit smoking/vaping and withdraw from the study at any time.
5. Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction based on medical history.
6. A clinically significant history of drug or alcohol abuse [defined as the consumption of more than 14 units of alcohol a week for male and female subjects] within the past two years.
7. Inability to communicate well with the Investigators (i.e., language problem, poor mental development or impaired cerebral function).
8. Subjects with a positive COVID-19 PCR (Antigen) test prior to Day 1.
9. Subject with a history of allergy/hypersensitivity to any of the study products.
10. Subjects who have a diagnosis of a clinically significant cognitive disorder.
11. Subjects who have used central nervous system enhancing or modulating medications within the last 3 months and is felt to be of clinical significance by the PI (or Deputy).
12. Subjects who have colour vision deficiency as determined by an Ishihara test performed at screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method