Nordic Spirit Pouch Nicotine Pharmacokinetics Abuse Liability
ConditionSmoking Behaviors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age22-65
SponsorJT International SA
About this trial
Nicotine pharmacokinetics and subjective effects of 9 Nordic Spirit Nicotine Pouch Products in adult cigarette smokers: A controlled, randomized, cross-over study with a balanced incomplete block design.
Eligibility criteria
Qualifiers
Voluntary consent to participate in this study documented on the signed ICF.
Healthy adult males and females ≥22 and ≤65 years of age, at screening.
Smokers and smokers that use other tobacco products (i.e., snus, moist snuff, Electronic Nicotine Delivery Systems, NP) will be considered. Smoking history (self-reported at screening) of an average of at least 5 but no more than 30 factory-manufactured combustible cigarettes daily for at least 12 months prior to screening. Brief periods (i.e., up to 7 consecutive days) of nonsmoking during the 3 months prior to screening (e.g., due to illness or participation in a study where smoking was prohibited) will be permitted.
Participants must demonstrate the ability to use a 12-mg NP for 30 minutes.
Disqualifiers
Self-reported puffers (i.e., adult smokers who draw smoke from the cigarette into the mouth and throat but do not inhale).
Any postponement of a quit attempt to participate in the study; or any attempts to quit smoking in the 3 months prior to Check-in).
Poor dentition that prevents participant from using nicotine gum.
History or presence of any type of malignant tumor or clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, would interfere with the absorption, distribution, metabolism, or excretion of nicotine or jeopardize the safety of the participant or impact the validity of the study results.
Trial design
Treatments tested in this trial
- Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions.
Treatment groups
55 Participants
are divided into 12 treatment groups12
Treatment groupsSee each treatment group below.
Sponsors and collaborators
JT International SA
Lead sponsor
ICON Clinical Research
Collaborator
Source ClinicalTrials.gov