Nicotine Pouch Pharmacokinetics Abuse Liability (NCT07476144)

🧪 Interventions in This Study

• Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Voluntary consent to participate in this study documented on the signed ICF.
2. Healthy adult males and females ≥22 and ≤65 years of age, at screening.
3. 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.
4. Participants must demonstrate the ability to use a 12-mg NP for 30 minutes.
5. 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.
6. 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).
7. 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.
8. Positive urine cotinine (≥200 ng/mL) at screening.
9. Exhaled carbon monoxide ≥8 ppm at screening.
10. Male participants, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from first Check-in (Day -1) to the clinical site until 90 days after the last administration of study product. Adequate contraception for the male participant (and his female partner, if she is of childbearing potential) is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm, a cervical cap, or a condom. Total abstinence from heterosexual intercourse, in accordance with the lifestyle of the subject, is also acceptable.
11. Negative pregnancy test at screening and first Check-in (Day -1) for all female participants.
12. Female participants who are heterosexually active and of childbearing potential (e.g., neither surgically sterile at least 6 months prior to first Check-in nor postmenopausal with amenorrhea for at least 12 months prior to first Check-in with FSH levels consistent with postmenopausal status) must have been using one of the following forms of contraception for the time period indicated and agree to continue using it through completion of the study:

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

• AMR — Knoxville, Tennessee
• ICON San Antonio — San Antonio, Texas

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.