Nordic Spirit Pouch Nicotine Pharmacokinetics Abuse Liability

Part of paid clinical trials in Knoxville, Tennessee.

Sponsor
JT International SA
Study ID
NCT07476144
Phase
PHASE1
Status
Recruiting
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Conditions

  • Smoking Behaviors

Eligibility Criteria

Sex
ALL
Age
22 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. — DRUG
    Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. The pouch is not to be swallowed, chewed or broken. At the end of the 30-minute period, participants will remove the pouch and the study staff will collect and dispose of it accordingly. Nicotine pouches deliver nicotine through the mucous membranes of the mouth.

Study Details

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.

Key Dates

Start date
Jan 8, 2026
Status verified
Mar 2026
Primary completion
Apr 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
55 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Nordic Spirit Nicotine Pouch Dark Fizz (6 mg nicotine/pouch) (Test Product)
  • Experimental: Nordic Spirit Nicotine Pouch Forest Berries (9 mg nicotine/pouch) (Test Product)
  • Experimental: Nordic Spirit Nicotine Pouch Frosty Mint (9 mg nicotine/pouch) (Test Product)
  • Experimental: Nordic Spirit Nicotine Pouch Frosty Mint (12 mg nicotine/pouch) (Test Product)
  • Experimental: Nordic Spirit Nicotine Pouch Frosty Berry (12 mg nicotine/pouch) (Test Product)
  • Experimental: Nordic Spirit Nicotine Pouch Raspberry (6 mg nicotine/pouch) (Test Product)
  • Experimental: Nordic Spirit Nicotine Pouch Sweet Mint (3 mg nicotine/pouch) (Test Product)
  • Experimental: Nordic Spirit Nicotine Pouch Sweet Mint (6 mg nicotine/pouch) (Test Product)
  • Experimental: Nordic Spirit Nicotine Pouch Sweet Mint (9 mg nicotine/pouch) (Test Product)
  • Active Comparator: ZYN 6 mg Wintergreen Nicotine Pouch (In-category Comparator Product)
  • Other: Nicorette 4 mg Mint Nicotine Gum (Reference Product)
  • Other: Combustible Cigarette (menthol or nonmenthol), participant's usual brand (Reference Product)

Primary Outcome Measure

Nordic Spirit pouch nicotine pharmacokinetics and abuse liability [ Time Frame: 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 ]

Locations (2)

FacilityCityStateZIPSite coordinators
AMRKnoxvilleTennessee37920
William B Smith, MD
[email protected]
(865)305-9100
ICON San AntonioSan AntonioTexas78209
Cassandra Key, MD
[email protected]
210-283-4500

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