Abuse Liability of Two Modern Oral Nicotine Pouched Products

Sponsor
RAI Services Company
Study ID
NCT07595055
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
  • Modern Oral Pouch Wintergreen-A 9 mg Nicotine — OTHER
    -A 9 mg Nicotine
  • Modern Oral Pouch Wintergreen-B 9 mg Nicotine — OTHER
    -B 9 mg Nicotine
  • UB loose or pouched moist snuff — OTHER
    UB loose or pouched moist snuff

Study Details

This is a single-site, open-label, randomized, 4-way 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 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
May 19, 2026
Start date
Jun 15, 2026
Status verified
May 2026
Primary completion
Jul 31, 2026
Completion
Nov 30, 2026

Study Design

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

Arms

  • Experimental: Product usage order ASBC
    Subjects will use each of the 4 products during an evaluation period, followed by a 1 hour Test Session and a 7 hour ad lib session
  • Experimental: Product usage order BACS
    Subjects will use each of the 4 products during an evaluation period, followed by a 1 hour Test Session and a 7 hour ad lib session
  • Experimental: Product usage order CBSA
    Subjects will use each of the 4 products during an evaluation period, followed by a 1 hour Test Session and a 7 hour ad lib session
  • Experimental: Product usage order SCAB
    Subjects will use each of the 4 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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