Actively Recruiting
Nordic Spirit Pouch Nicotine Pharmacokinetics Abuse Liability
Led by JT International SA · Updated on 2026-03-17
55
Participants Needed
2
Research Sites
38 weeks
Total Duration
On this page
Sponsors
J
JT International SA
Lead Sponsor
I
ICON Clinical Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Nordic Spirit Pouch Nicotine Pharmacokinetics Abuse Liability
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary consent to participate documented on signed informed consent form.
- Healthy adults aged 22 to 65 years at screening.
- Current smokers or users of other tobacco products with a history of smoking 5 to 30 factory-made cigarettes daily for at least 12 months prior to screening.
- Ability to use a 12-mg nicotine pouch for 30 minutes.
- Willingness to abstain from THC use for 7 days before check-in if using THC.
- Generally healthy without significant medical abnormalities as assessed by medical history, physical exam, vital signs, ECG, and laboratory tests.
- Blood pressure at screening and check-in no higher than 150/90 mmHg after resting.
- Positive urine cotinine test (≥200 ng/mL) at screening.
- Exhaled carbon monoxide level ≥8 ppm at screening.
- Male participants must agree to use adequate contraception or abstain from sperm donation from check-in to 90 days after last product use.
- Negative pregnancy test at screening and check-in for females.
- Females of childbearing potential must use effective contraception before and during the study.
- Females of nonchildbearing potential must have undergone sterilization or be postmenopausal.
- Ability to communicate effectively and comply with study requirements.
- Willingness and ability to use all study products during confinement and product use sessions.
You will not qualify if you...
- Self-reported smokers who do not inhale smoke (puffers).
- Any quit attempts or postponement of quit attempts in the 3 months before check-in.
- Poor dental health preventing use of nicotine gum.
- History or presence of malignant tumors or significant diseases affecting safety or study validity.
- Current or past congestive heart failure.
- Conditions or therapies making participation unsuitable as judged by the investigator.
- Use of prescribed medications stopped less than 14 days before admission, except hormonal contraceptives.
- Use of over-the-counter or herbal medications stopped less than 14 days before admission, except acetaminophen.
- Clinically significant abnormal vital signs, exams, or lab findings.
- Positive tests for HIV, hepatitis B or C infections.
- Uncontrolled diabetes or fasting plasma glucose >126 mg/dL.
- Acute illness requiring treatment within 2 weeks before check-in.
- Recent surgery, trauma, alcohol or drug abuse, and alcohol consumption within 48 hours before check-in.
- Positive drug or alcohol screen at screening or check-in, except for THC with discretion.
- Fever at screening or check-in.
- BMI below 18.0 or above 40.0 kg/m2.
- Reduced kidney function or elevated liver enzymes.
- Pregnancy, lactation, or plans to become pregnant during the study.
- Recent use of bronchodilators, antibiotics, or medications affecting nicotine metabolism.
- Participation in other investigational studies or recent vaccinations.
- Recent blood or plasma donation beyond specified limits.
- Strenuous activity within 48 hours before check-in.
- Employment or litigation ties with the tobacco industry or study site.
- Unwillingness or inability to comply with study requirements.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
AMR
Knoxville, Tennessee, United States, 37920
Actively Recruiting
2
ICON San Antonio
San Antonio, Texas, United States, 78209
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
12
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