RecruitingPhase 1

Nordic Spirit Pouch Nicotine Pharmacokinetics Abuse Liability

United States55 participantsStarted 2026-01-08

Plain-language summary

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.

Who can participate

Age range22 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. Participants who use THC, must be willing to abstain from THC use for 7 days before Check-in and able to participate in the study without THC use.
✓. Participants must be generally healthy, free of lifetime malignant tumors, and without clinically significant abnormalities as assessed by the Investigator based on the review of medical and surgical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluations conducted at screening and Check-in, as applicable. A single repeat measurement/test may be performed to confirm vital signs, 12-lead ECG, and clinical laboratory tests abnormalities (i.e.,to confirm that a participant is eligible).
✓. Screening and first Check-in blood pressure ≤150/90 mmHg measured after being in the supine position or in the most recumbent position possible for at least 5 minutes. Two rechecks may be performed at the Principal Investigator's discretion.
✓. Positive urine cotinine (≥200 ng/mL) at screening.

Exclusion criteria

✕. 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.
✕. Current evidence or any history of congestive heart failure.
✕. Any other condition or prior therapy that, in the Investigator's opinion, would make the participant unsuitable for the study, or unable or unwilling to comply with the study procedures.
✕. All prescribed medication must have been stopped at least 14 days prior to (first) admission to the clinical site. An exception is made for hormonal contraceptives that may be used throughout the study.
✕. All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's wort) must have been stopped at least 14 days prior to (first) admission to the clinical site. An exception is made for acetaminophen that is allowed up to admission to the clinical site.

What they're measuring

Nordic Spirit pouch nicotine pharmacokinetics and abuse liability

Timeframe: Screening: Between Day -28 and Day -1 (Check-in) Assessment period: 1 assessment period at the clinical site from Day-1 (check in) to Day 6 Early Termination: At the time of early termination

Characterize nicotine PK Parameters.

Trial details

NCT IDNCT07476144

SponsorJT International SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04

View on ClinicalTrials.gov More Smoking Behaviors trials