Abuse Liability for Five Modern Oral Nicotine Products

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
RAI Services Company
Study ID
NCT07132814
Status
Recruiting
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Conditions

  • Smoking
  • Smoking Behaviors
  • Tobacco Smoking
  • Tobacco Use

Eligibility Criteria

Sex
ALL
Age
21 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Product A — OTHER
    Usual Brand (UB) filtered, non-menthol or menthol combustible cigarette
  • Product B — OTHER
    8 mg nicotine oral product
  • Product C — OTHER
    12 mg nicotine oral product
  • Product D — OTHER
    6 mg nicotine oral product
  • Product E — OTHER
    8 mg nicotine oral product
  • Product F — OTHER
    8 mg nicotine oral product
  • Product N — OTHER
    Nicorette® White Ice Mint 4 mg nicotine polacrilex gum

Study Details

This is a two-site, open-label, randomized, 4-way (2 arm) cross-over study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics \[PD\]) and plasma nicotine uptake (pharmacokinetics \[PK\]) during and following ad libitum use of the study investigational products (IPs) by generally healthy smokers

Key Dates

Start date
Dec 15, 2025
Status verified
Dec 2025
Primary completion
Apr 15, 2026
Completion
Aug 31, 2026

Study Design

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

Arms

  • Experimental: Arm 1
    Enrolled subjects will be randomized to one of four product use sequences, such that one of the four IPs (A, B, C, D) will be used in each of the four test sessions.
  • Experimental: Arm 2
    Enrolled subjects will be randomized to one of four product use sequences, such that one of the four IPs (A, E, F, N) will be used in each of the four test sessions.

Primary Outcome Measure

AUECPL 5-240 [ Time Frame: 5 minutes to 240 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dr. Vince Clinical ResearchOverland ParkKansas66212
Patricia Deluca
[email protected]

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Dr. Vince Clinical Research· Overland Park, KS

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