A study in healthy smokers to determine the delivery of nicotine and satisfaction/craving relief gained from an e-cigarette containing different solutions (e-liquids)
- Conditions
- SmokingInjury, Occupational Diseases, Poisoning
- Registration Number
- ISRCTN74070762
- Lead Sponsor
- British American Tobacco (Investments) Limited (UK)
- Brief Summary
2017 results in https://www.ncbi.nlm.nih.gov/pubmed/27935787
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
1. Subjects will be males or non-pregnant, non-lactating females between 21 and 55 years of age inclusive
2. Women of child-bearing potential should be using one of the following acceptable methods of contraception: combined (estrogen and progestogen containing) oral, intravaginal or transdermal hormonal contraception associated with inhibition of ovulation; progestogen-only hormonal contraception, either oral, injected or implanted, associated with inhibition of ovulation; progestogen-only oral hormonal contraception where inhibition of ovulation is not the primary mode of action; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; male or female condom with or without spermicide; cap, diaphragm or sponge with spermicide.
3. Women of nonchildbearing potential may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for more than 1 year (with follicle-stimulating hormone [FSH] level greater than or equal to 8 mIU/mL) and must have a negative serum pregnancy test result during screening. Women who are surgically sterile must provide documentation of the procedure by an operative report.
4. Subjects must be in good health as determined by medical history, vital signs, blood biochemistry, haematology, urinalysis and physical examination.
5. Subjects with negative HIV and Hepatitis B and C results.
6. Subjects must have a body mass index (BMI) between 18 and 30 kg/m2 inclusive. Male subjects must have a weight between 50 and 110kg and female subjects between 40 and 90kg.
7. No clinically significant abnormalities in blood pressure values (the differences between supine and standing BP are less than 20 mmHg) with no symptomatic evidence of postural hypotension.
8. Subjects will have negative results for the urinary drug of abuse and ethanol screening test.
9. Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions.
10. Prior to study start, subjects must be daily smokers of at least 10 factory-produced cigarettes and have smoked continuously for a minimum of one year. Subjects current brand of cigarette will have a machine-smoked ISO tar yield of 8-10 mg. Smoking status will be confirmed with a Smokerlyzer breath CO >10ppm and a urinary cotinine level of >200ng/ml at screening. Subjects should be familiar with the use of e cigarettes but not currently dual-using cigarettes and e-cigarettes
1. Subjects who have a history of, or clinically active significant, neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological disease or other major disorders.
2. Subjects with significant allergies who in the opinion of the Principal Investigator should not be included.
3. Subjects who have been diagnosed with urticaria or asthma.
4. Subjects with a recent history of or current drug or alcohol abuse who in the opinion of the Investigator should not be included. Excessive intake of alcohol within the last 6 months, defined as a regular maximum weekly intake of greater than 7 drinks for women or 14 drinks for men. One drink is defined as one pint of regular beer (5% alcohol), 200 ml of wine (12% alcohol), or 25 ml of distilled spirits (40% alcohol).
5. Subjects with an inability to communicate well with the Investigator/study staff (i.e., language problem, poor mental development or impaired cerebral function).
6. Subjects who are participating in another clinical research study or who have participated in a clinical research study in the last 3 months.
7. Subjects who have had treatment with prescription medications within 21 days or over-the-counter medication within 72 hours of the planned first product use occasion. For female subjects, oral contraceptives, hormonal contraceptive devices and replacement hormonal therapies are not included in the list of drugs leading to exclusion.
8. Subjects who have used any drugs or substances (except tobacco) known to be strong inducers or inhibitors of any CYP enzymes (formerly known as cytochrome P450 enzymes) within a 28 days period prior to first prodct administration. For a list of such drugs and substances, please refer to http://medicine.iupui.edu/clinpharm/ddis/main-table/.
9. Subjects who have had any treatment with smoking cessation medications (e.g. Bupropion, Champix, any nicotine replacement therapy or nicotine delivery systems) within 30 days of the planned first product use occasion.
10. Subjects with any other clinically significant medical history, in the Investigator's opinion, including conditions which might affect drug absorption, metabolism or excretion.
11. Female subjects, who are pregnant or become pregnant during the course of the study.
12. Subjects who have lost or donated more than 450ml blood, plasma or platelets within the 3 months preceding the first product administration.
13. Subjects who are currently trying to stop smoking or considering stopping in the next two months.
14. Subjects who are unwilling or unable to comply with the study requirements.
15. Subjects who in the opinion of the Investigator should not participate in the study for any other reason.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Plasma nicotine concentration Cmax and Tmax. Measured at timepoints -5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 14.5, 30, 45, 60, 75 and 90 minutes following the start of product use <br>2. Subjective measurements of cravings/urges. Measured at timepoints -2, 1.25, 3.25, 5.5, 7.5, 10.5, 14.5, 30, 45, 60, 75 and 90 minutes following the start of product use. This will be done using a standard single-item question of cravings/urges. <br>3. Product satisfaction. This will be done using a customised panel examining numerous aspects of satisfaction with product use.
- Secondary Outcome Measures
Name Time Method 1. Product (cigarette and e-cigarette) consumption per day during ambulatory periods<br>2. Heart rate during the first 12 minutes of product use<br>3. Cotinine and hydroxycotinine at the same timepoints as nicotine measurements