Assessing nicotine pouches for daily nicotine users

An Explorative, Open-label, Randomised, 3-way Cross-over Study to Assess the Pharmacokinetics, Pharmacodynamics, Nicotine Extraction, Palatability, and Subjective Effects After Single Use of Nicotine Pouches in Daily Nicotine Users.

This study is testing how different nicotine pouches affect daily nicotine users to see if they are safe and how they work compared to other tobacco products.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 25 Years to 55 Years
• Sex: All
• Sponsor: Emplicure AB (Industry-sponsored)
• Locations: 1 site (Uppsala)
• Trial ID: NCT06170138 on ClinicalTrials.gov

What this trial studies

This study evaluates the pharmacokinetics, pharmacodynamics, safety, and subjective effects of nicotine pouches in daily nicotine users through an open-label, randomized, 3-way cross-over design. Participants will use different nicotine pouch products while abstaining from other tobacco/nicotine products for at least 12 hours prior to each use. The goal is to understand nicotine exposure and product behavior, providing critical data for product optimization and consumer safety. This research aims to contribute to the scientific knowledge surrounding nicotine pouches as potential alternatives to smoking.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 25 to 55 who have used oral tobacco/nicotine products for at least one year and consume a minimum of five nicotine pouches daily.

Not a fit: Patients who do not use nicotine products or are under 25 years old may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into safer nicotine alternatives for individuals with nicotine use disorder.

How similar studies have performed: While the specific approach of this study may be novel, similar studies assessing nicotine delivery methods have shown promise in understanding user experiences and safety.

Eligibility criteria

Inclusion Criteria:

1. Willing and able to give written informed consent for participation in the study.
2. Subjects who have used oral tobacco/nicotine products for ≥1 year, with a minimum daily consumption of 5 or more pouches with a pouch strength of 3-9 mg nicotine/pouch. Concomitant occasional use of other nicotine products (e.g., smoking, vaping) is allowed, as judged by the Investigator at the time of the screening visit.
3. Healthy male or female subject aged 25 to 55 years, inclusive, at the time of the screening visit.

   Female subjects of childbearing potential must be willing to use a sufficient contraceptive method for the duration of the study, this includes mechanical barrier (e.g., a male condom or a female diaphragm), combined \[oestrogen and progestogen containing\] hormonal contraception associated with inhibition of ovulation \[oral, intravaginal, transdermal\], progestogen-only hormonal anticonception associated with inhibition of ovulation \[oral, injectable, implantable\], intra uterine device (IUD) or intra uterine system (IUS). Sexual abstinence is allowed when this is the preferred and usual lifestyle of the subject.
4. Body Mass Index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 and a minimum weight of ≥ 50 kg.
5. Medically healthy subject without abnormal clinically significant medical history, physical findings, vital signs, ECG and laboratory values at the time of the screening visit, as judged by the Investigator.
6. Positive urine cotinine test (≥200 ng/mL) at the screening visit.

Exclusion Criteria:

1. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
2. After 10 minutes supine rest at the screening visit, any vital signs values outside the following ranges: - Systolic blood pressure: \<90 or \>140 mmHg, or - Diastolic blood pressure \<50 or \>90 mmHg, or - Pulse \<40 or \>90 bpm
3. Any surgical or medical condition, including abnormal salivation (also 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 because of participation in the study, influence the results, or the subject's ability to participate in the study.
4. A history of diagnosed severe allergy/hypersensitivity or ongoing manifestations of severe allergy/hypersensitivity to aroma compounds (including fragrances and/or flavourings), as judged by the Investigator.
5. Any planned major surgery within the duration of the study.
6. Subjects who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the study.
7. Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis C antibodies and/or HIV.
8. Positive screening result for drugs of abuse or alcohol at the screening visit or on admission to the study site prior to IP use at Visits 2 to 4. (Positive results that are expected given the subject's medical history and prescribed medications can be disregarded as judged by the Investigator.)
9. Presence or history of drug abuse, as judged by the Investigator.
10. History of alcohol abuse or excessive intake of alcohol, 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), including pro re nata (as needed) use.
13. Current, ongoing use of any medication known to be able to interfere with adrenaline testing, including but not limited to central nervous system stimulants (amphetamines), also including pro re nata (as needed) use, as judged by the Investigator.
14. Plasma donation within 1 month of the screening visit or blood donation (or corresponding blood loss) during the last 3 months prior to the screening visit.
15. Subjects who intend to change their nicotine consumption habit, including the intention to stop using nicotine products, within the next 3 months from the screening visit, as judged by the Investigator.
16. The Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.

Where this trial is running

Uppsala

• Clinical Trial Consultants AB (CTC) — Uppsala, Sweden (Recruiting)

Study contacts

• Principal investigator: Erik Rein-Hedin, MD — Clinical Trial Consultants AB (CTC)
• Study coordinator: Anna Franzén, PhD

Conditions Nicotine Use Disorder; nicotine; nicotine pouch products