Nicotine Pouch Pharmacokinetics Abuse Liability

Part of paid clinical trials in Knoxville, Tennessee.

Sponsor
JT International SA
Study ID
NCT07476144
Phase
PHASE1
Status
Active Not Recruiting

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 Investigational Nicotine Pouch Products in adult cigarette smokers: A controlled, randomized, cross-over study with a balanced incomplete block design.

Key Dates

First listed
Mar 17, 2026
Start date
Jan 8, 2026
Status verified
Aug 2026
Primary completion
Jul 31, 2026
Completion
Oct 31, 2026

Study Design

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

Arms

  • Experimental: Nicotine Pouch Investigational Product (Test Product A)
  • Experimental: Nicotine Pouch Investigational Product (Test Product B)
  • Experimental: Nicotine Pouch Investigational Product(Test Product C)
  • Experimental: Nicotine Pouch Investigational Product (Test Product D)
  • Experimental: Nicotine Pouch Investigational Product (Test Product E)
  • Experimental: Nicotine Pouch Investigational Product (Test Product F)
  • Experimental: Nicotine Pouch Investigational Product (Test Product G)
  • Experimental: Nicotine Pouch Investigational Product (Test Product H)
  • Experimental: Nicotine Pouch Investigational Product (Test Product I)
  • Active Comparator: Nicotine Pouch (In-category Comparator Product)
  • Other: Nicorette 4 mg Mint Nicotine Gum (Reference Product)
  • Other: Combustible Cigarette participant's usual brand (Reference Product)

Primary Outcome Measure

Investigational Product 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-
ICON San AntonioSan AntonioTexas78209-

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