Abuse Liability of Four Modern Oral Nicotine Products

Sponsor
RAI Services Company
Study ID
NCT07685795
Status
Not Yet 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

  • Usual Brand (UB) filtered, menthol or non-menthol combustible cigarette — OTHER
    Usual Brand (UB) filtered, menthol or non-menthol combustible cigarette
  • Wintergreen (fleece A), 12 mg nicotine — OTHER
    Wintergreen (fleece A), 12 mg nicotine
  • Wintergreen (fleece A), 9 mg nicotine — OTHER
    Wintergreen (fleece A), 9 mg nicotine
  • Wintergreen (fleece B), 9 mg Nicotine — OTHER
    Wintergreen (fleece B), 9 mg Nicotine
  • Watermelon Mint (fleece A), 9 mg Nicotine — OTHER
    Watermelon Mint (fleece A), 9 mg Nicotine
  • UB moist snuff (UB MST), either loose or portioned (pouched). — OTHER
    UB moist snuff (UB MST), either loose or portioned (pouched).

Study Details

This is a single-site, open-label, randomized, 6-way crossover study designed to evaluate elements of abuse liability (AL) including subjective effects, physiological measures (pharmacodynamics \[PD\]), and plasma nicotine uptake (pharmacokinetics \[PK\]) during controlled monitored use and following ad libitum use of the study investigational products (IPs) by generally healthy smokers who are also users of smokeless tobacco.

Key Dates

First listed
Jul 6, 2026
Start date
Jul 15, 2026
Status verified
Jun 2026
Primary completion
Sep 15, 2026
Completion
Jan 31, 2027

Study Design

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

Arms

  • Experimental: Product usage order ASDECB
    Subjects will use each of the 6 products during an evaluation period, followed by a 1 hour Test Session and a 7 hour ad lib session
  • Experimental: Product usage order BAESDC
    Subjects will use each of the 6 products during an evaluation period, followed by a 1 hour Test Session and a 7 hour ad lib session
  • Experimental: Product usage order CBSAED
    Subjects will use each of the 6 products during an evaluation period, followed by a 1 hour Test Session and a 7 hour ad lib session
  • Experimental: Product usage order DCABSE
    Subjects will use each of the 6 products during an evaluation period, followed by a 1 hour Test Session and a 7 hour ad lib session
  • Experimental: Product usage order EDBCAS
    Subjects will use each of the 6 products during an evaluation period, followed by a 1 hour Test Session and a 7 hour ad lib session
  • Experimental: Product usage order SECDBA
    Subjects will use each of the 6 products during an evaluation period, followed by a 1 hour Test Session and a 7 hour ad lib session

Primary Outcome Measure

AUECPL 5-60 [ Time Frame: 5 minutes to 60 minutes ]

Central Contacts

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