Nicotine use Mental and Behavioural Disorders
Conditions
Interventions
Interventions:
Investigational products (IPs):
• Nicotine pouch 1 (NP1) – Smooth 1.5 mg
• NP2 – Wintergreen 1.5 mg
• NP3 – Smooth 3 mg
Administration and assessments:
Subjects will report to a stu
Sponsors
Swedish Match North Europe AB
Eligibility
Sex/Gender
All
Age
21 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Be willing and able to provide written informed consent for participation in the study. 2. Be a user of NP products for =1 year, with a minimum daily consumption of five pouches, and be willing and able to use NP products while abstaining from all other nicotine products for at least 12 hours prior to and during Visits 2 to 4. Users of other nicotine products are eligible; however, subjects must primarily be users of NP products to be included. 3. Be a healthy male or female subject aged 21 to 60 years, inclusive 4. Be medically healthy, without clinically significant abnormalities in medical history, physical examination findings, vital signs, ECG, and/or laboratory results (including hepatitis B/C and human immunodeficiency virus [HIV]) at the time of the screening visit, as judged by the Investigator. 5. Female subjects of childbearing potential must either practice abstinence from heterosexual intercourse (if this reflects their preferred and usual lifestyle) or agree to use a highly effective method of contraception with a failure rate of <1%/year to prevent pregnancy for the duration of the study. Female subjects of childbearing potential with an exclusive male partner who has undergone vasectomy may choose not to use contraceptives. Acceptable methods of contraception include: 5.1. Combined (estrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), 5.2. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), and 5.3. Intrauterine device or intrauterine hormone-releasing system.
Exclusion criteria
Exclusion criteria: 1. A history of diagnosed hypertension or any cardiovascular disease, or current manifestations of either, as judged by the Investigator. 2. Any surgical or medical condition, including abnormal salivation (including pharmaceutically induced), or history thereof, which, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism, or excretion of the IP or may either put the subject at risk due to study participation, influence the results, or impair the subject’s ability to comply with the study. 3. A history of diagnosed severe allergy/hypersensitivity or current manifestations of severe allergy/hypersensitivity to aroma compounds (including fragrances and/or flavorings), as judged by the Investigator. 4. Poor venous access or fear of needles. 5. Any planned major surgery during the study period. 6. Pregnancy, currently breastfeeding, or intention to become pregnant during the course of the study. 7. Positive screening results for serum hepatitis B surface antigen, hepatitis C antibodies, and/or HIV. 8. Positive test results for drugs of abuse or alcohol at screening or upon admission to the study site prior to start of IP use. Positive results consistent with the subject’s medical history and prescribed medications may be disregarded, as judged by the Investigator. 9. History of alcohol abuse or excessive alcohol intake, as judged by the Investigator. 10. Presence or history of drug abuse, as judged by the Investigator. 11. History of, or current use of anabolic steroids, as judged by the Investigator 12. Current, ongoing use of beta-adrenergic blocking agents (beta blockers) or central stimulant medications (psychostimulants), e.g., for the treatment of attention deficit hyperactivity disorder (ADHD), including pro re nata (as needed) use, at the discretion of the Investigator. 13. Plasma donation, blood donation or corresponding blood loss within 1 month prior to screening. 14. Intention to change nicotine consumption habits, including plans to stop using nicotine products, within the next 3 months of the screening visit, as judged by the Investigator. 15. The Investigator considers the subject unlikely to comply with study procedures, restrictions, and requirements.
Countries
Sweden
Contacts
Public ContactCamilla Pramfalk
Outcome results
None listed