Nicotine dependence Mental and Behavioural Disorders Mental and behavioural disorders due to use of tobacco
Conditions
Interventions
This is an open-label study of the NJOY Kings e-cigarette. Subjects will test the NJOY King during a one week period. They will instructed to use the e-cigarettes as often as they like at times that t
Sponsors
NJOY Inc. (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the consent form. 2. Age:18-65 years 3. Body Mass Index: Subject has a BMI within the range of 18-35 kg/m2 4. Compliance: Understands and is willing, able, and likely to comply with all the study procedures and restrictions. 5. General Health: Good general health with (in the opinion of the study doctor) no clinically significant and relevant abnormalities of medical history 6. Smoking status: Cigarette smokers who smoke at least 10 cigarettes per day and are not currently attempting to quit smoking 7. Carbon Monoxide: CO level greater than 10ppm at the screening visit and less than 10ppm at Visit 3 8. Contraception: Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception
Exclusion criteria
Exclusion criteria: 1. Pregnancy: Women who are pregnant or who have a positive urine pregnancy test 2. Breast-feeding: Women who are breast-feeding 3. Allergy/Intolerance: Known allergy to heparin, or allergy or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients 4. Clinical Study/Experimental Medication: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit 5. Previous participation in this study 6. E-cigarette use: Any use of an e-cigarette within 14 days of the screening visit 7. Substance Abuse: Positive drugs of abuse urine screening at the screening and any subsequent visits. Tested drugs include cocaine, amphetamines, methamphetamines, cannabis, opiates, (morphine, heroin), phencyclidine, barbiturates, benzodiazepine. 8. Alcohol abuse?Self-reported use of more than 21 drinks per week. A drink is defined as 1.5 oz of spirits (e.g. whiskey, vodka), 12 oz of beer, or 5 oz of wine. 9. Personnel: An employee of the sponsor or the study site or members of their immediate family 10. Prior Concomitant Medications: Use of any prescription psychoactive medication (such as but not limited to antidepressants, anti-psychotics, anxiolytics) within 14 days of the Testing visit. Use of any nicotine replacement therapy within 30 days of the Screening Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| On the Visit 3 testing day the changes in blood nicotine levels, heart rate, carbon monoxide, craving for cigarettes and nicotine withdrawal symptoms pre- and post 10-puff sessions of using the NJOY King after 12 hours of abstinence from nicotine. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in number of cigarettes per day during the one week NJOY testing period. Subjects perceptions on their use of the NJOY e-cigarettes during the one week testing period. | — |
Countries
United States of America
Outcome results
None listed