A study to assess if nicotine delivered via an e-cigarette can have an effect on appetite in healthy adult smokers

Not Applicable

Completed

• Conditions: Cigarette smoking; Not Applicable; Tobacco and nicotine use

• Registration Number: ISRCTN72435551
• Lead Sponsor: British American Tobacco (United Kingdom)

Brief Summary

2022 Protocol article in https://doi.org/10.18203/2349-3259.ijct20222692 (added 14/02/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-25
• Study Completion: 2021-07-20
• Last Update Posted: 27 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

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 the screening until the end of the follow-up period;
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 Study Session 1 (Day 1) (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, respiration rate, oral temperature) determined within 28 days before Study Session 1 (Day 1);
9. Subjects who are current daily users of conventional factory-made cigarettes and/or roll your own cigarettes (minimum of 10 cigarettes per day) and who have done so 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). 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 regular breakfast eaters and have no current diagnosis of any eating disorder;
11. Subjects who are willing to consume the study standardised breakfast and ad libitum meal;
12. Subjects who are willing to comply with the study protocol;
13. Subject must be available to complete the study (including all follow up visits);
14. Subject must satisfy an Investigator about his/her fitness to participate in the study;
15. Subject must provide written informed consent to participate in the study;
16. Subjects who are willing to use a tobacco flavoured e-cigarette.

Exclusion Criteria

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). Subjects who are observed as non-inhalers at Admission by the clinic staff will be excluded;
4. Subjects who, prior to enrolment, are planning to quit/alter smoking/vaping 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;
6. A clinically significant history of drug or alcohol abuse [defined as the consumption of more than 14 units for male and female subjects) of alcohol a week] 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. Vegans, vegetarians or those with other dietary restrictions or food-related allergies (e.g., restrictions for medical, religious or cultural reasons, etc);
9. Subjects with a positive COVID-19 PCR (Antigen) test prior to Day 1.

Study & Design

• Study Type: Interventional
• Study Design: Not specified