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Nordic Spirit Pouch Nicotine Study

This study is looking at how your body absorbs nicotine from Nordic Spirit nicotine pouches and how likely people are to misuse them. We are also comparing these pouches to your usual brand of cigarettes and Nicorette gum. You might be able to join if you are a healthy adult smoker between 22 and 65 years old. The main goal is to understand the nicotine levels in your body after using the pouches. The current status of this study is unclear, and it plans to enroll 55 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a controlled, randomized, cross-over study with a balanced incomplete block design.
What's involved
You will place a Nordic Spirit pouch between your top lip and gum for 30 minutes. This will happen during one assessment period at the clinical site, lasting from Day -1 (check-in) to Day 6.
Compensation
Not stated in the trial record.
Follow-up
The assessment period at the clinical site is from Day -1 (check-in) to Day 6. Early termination assessments occur at the time of early termination.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07476144

Nicotine Pouch Pharmacokinetics Abuse Liability

Active, Not Recruiting
PHASE1Ages 22–65Interventional
JT International SA
~55 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions.

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Investigational Product nicotine pharmacokinetics and abuse liability
Measured over 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
+1 more outcome measured

Conditions

Smoking Behaviors

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Smoking Behavior

Where it's being run

2 sites across 2 states
Tennessee1
Texas1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Hormonal (e.g., oral, vaginal ring, transdermal patch, implant, injection) consistently for at least 3 months prior to first Check-in, when used in combination with male condoms with spermicide (use of NuvaRing is at the Principal Investigator's discretion)
Double barrier (e.g., condom with spermicide or diaphragm with spermicide) consistently for at least 2 weeks prior to first Check-in
Intrauterine device or system (utilize Principal Investigator discretion regarding use of hormonal or nonhormonal devices) for at least 3 months prior to first Check-in
Exclusive partner who is clinically sterile (i.e., documented infertility or surgical sterilization; see below for additional information on sterility) or has been vasectomized for at least 6 months (inclusive) prior to first Check-in
Note: Sexual abstinence, defined as refraining from intercourse, is allowed when this is in line with the preferred and usual lifestyle of the participant. Female participants of childbearing potential who are not currently engaging in heterosexual intercourse must agree to use one of the above methods of birth control through completion of study, in the event that they have heterosexual intercourse during the course of the study. 13. Female participants who are of nonchildbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to first Check-in:
Hysteroscopic sterilization (including Essure or similar nonsurgical sterilization procedures)
Bilateral tubal ligation or bilateral salpingectomy
Hysterectomy
Bilateral oophorectomy
Or be postmenopausal with amenorrhea for at least 12 months prior to first Check-in and have FSH levels consistent with postmenopausal status. 14. Able to communicate effectively with the study personnel and willing to comply with the requirements of the study. 15. Willing and able to use all of the study products in-confinement and product use sessions

What this trial measures

  • Investigational Product nicotine pharmacokinetics and abuse liabilityScreening: 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

    The purpose of this study is to acquire scientific data related to nicotine PK and abuse liability NPs:Nicotine uptake levels. * Compare the abuse liability of Investigational products to UBCC, NRT and a NP comparator * Safety data in humans This study will characterize the plasma nicotine PK, subjective effects, and PD (heart rate and blood pressure) of IP's compared to UBCC, NRT, and an NP comparator. The subjective effects measures chosen for this study are standard measures to evaluate tobacco products: * VAS measures of Assessment of Product Liking, Intent-to-Use-Again, Product Direct Effect, and Urge to Smoke questionnaires. * 7-point Likert scale for the Product Evaluation Scale.

  • Characterize nicotine PK Parameters.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

    To characterize nicotine pharmacokinetic (PK) parameters following a single ad libitum administration of 9 Investigational nicotine pouches (NPs) products relative to usual brand combustible cigarette (UBCC), Nicorette (NRT) gum, and a comparator NP product. AUC0-180: Area under the nicotine concentration-time curve calculated using linear trapezoidal summation from time zero to 180 minutes