A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery System Products

Sponsor
RAI Services Company
Study ID
NCT07739797
Status
Not Yet Recruiting

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Conditions

  • Smoking ( Cigarette)
  • Smoking Behaviors
  • Tobacco Use

Eligibility Criteria

Sex
ALL
Age
21 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Golden Tobacco Chill 5% (4) 6.5W — OTHER
    Golden Tobacco Chill 5% (4) 6.5W
  • Glacier Menthol 5% (4) 6.5W — OTHER
    Glacier Menthol 5% (4) 6.5W
  • Fresh Mint 5% (4) 6.5W — OTHER
    Fresh Mint 5% (4) 6.5W
  • Fresh Mint 5% (4) 4.5W — OTHER
    Fresh Mint 5% (4) 4.5W
  • Fresh Mint 5% (3) 6.5W — OTHER
    Fresh Mint 5% (3) 6.5W
  • Fresh Mint 5% (3) 5.5W — OTHER
    Fresh Mint 5% (3) 5.5W
  • Fresh Mint 5% (2) 6.5W — OTHER
    Fresh Mint 5% (2) 6.5W
  • Usual Brand Cigarette — OTHER
    Usual Brand Cigarette

Study Details

This will be a randomized, open-label, 8-way crossover, single-site 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 electronic nicotine delivery system (ENDS) investigational products (IPs). The study will be conducted in a confinement setting among generally healthy adult smokers of combustible cigarettes and dual users of cigarettes and ENDS products.

Key Dates

First listed
Jul 31, 2026
Start date
Oct 1, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Apr 30, 2027

Study Design

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

Arms

  • Experimental: Product usage order BCNDHEGF
    Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session.
  • Experimental: Product usage order CDBENFHG
    Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session.
  • Experimental: Product usage order DECFBGNH
    Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session.
  • Experimental: Product usage order EFDGCHBN
    Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session.
  • Experimental: Product usage order FGEHDNCB
    Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session.
  • Experimental: Product usage order GHFNEBDC
    Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session.
  • Experimental: Product usage order HNGBFCED
    Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session.
  • Experimental: Product usage order NBHCGDFE
    Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session.

Primary Outcome Measure

AUC nic 3-240 [ Time Frame: 3 minutes to 240 minutes ]

Central Contacts

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