An interventional study of Product A and Product B in Smoking and Tobacco Use, sponsored by RAI Services Company. Completed at 2 sites in United States. Open to participants aged 21 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by RAI Services Company · Not applicable, Interventional, and Other
This is a two-site, open-label, randomized, 8-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 and following ad libitum use of the study investigational products (IPs) by generally healthy smokers.
Cigarette smokers naïve to smokeless tobacco products (ST) and smokers also using ST will be recruited into this AL study to evaluate elements of AL of six modern oral nicotine products compared to combustible cigarettes (CC) and nicotine polacrilex gum. An attempt will be made for at least one-third of the study population to include smokers using ST.
Potential subjects will complete a pre-screening telephone interview. They will complete a Screening Visit to assess their eligibility within 45 days prior to check-in and enrollment.
Starting on check in day (Day -1), subjects will check-in at the clinical site to complete procedures to confirm eligibility. Eligible subjects will be enrolled, randomized and confined for 10 days (9 nights). Prior to the first product acclimation period, subjects will conduct a product familiarization of three of the modern oral nicotine products. Subjects will be randomized to one of eight product use sequences (using a Williams Design) in which they will evaluate one IP in each of eight separate Test Sessions, such that each subject will evaluate eight IPs, including six modern oral nicotine products, and both a high-AL comparator (subject's usual brand [UB] cigarette) and a low-AL comparator (a commercially available nicotine replacement therapy [NRT] nicotine gum).
On Day 2 and continuing through Day 9, subjects will participate in Test Sessions that will last approximately 4 hours. Each Test Session will include collection of both types of PD measures (subjective and physiological) and PK measures prior to, during, and following IP use.
On the half day prior to each respective Test Session, a Product Acclimation Period will allow subjects ad libitum use of the subsequent IP (at least two trial uses) as per randomized sequence for product acclimation prior to use in the next day's Test Session. Subjects can also use their UB cigarettes ad libitum, until the 12-hour tobacco and nicotine abstinence period begins prior to each Test Session, as long as the minimum use requirement for randomized IP is met.
268 studies on the registry are indexed under Smoking; 136 are open to participants now.
This study's enrollment of 40 is below the median of 120 across 211 interventional studies indexed under Smoking.
Browse Smoking studies →RAI Services Company is the lead sponsor of 48 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session
Other: Product A · Other: Product B · Other: Product C · Other: Product D · Other: Product E · Other: Product F · Other: Product G · Other: Product N
Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session
Other: Product A · Other: Product B · Other: Product C · Other: Product D · Other: Product E · Other: Product F · Other: Product G · Other: Product N
Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session
Other: Product A · Other: Product B · Other: Product C · Other: Product D · Other: Product E · Other: Product F · Other: Product G · Other: Product N
Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session
Other: Product A · Other: Product B · Other: Product C · Other: Product D · Other: Product E · Other: Product F · Other: Product G · Other: Product N
Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session
Other: Product A · Other: Product B · Other: Product C · Other: Product D · Other: Product E · Other: Product F · Other: Product G · Other: Product N
Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session
Other: Product A · Other: Product B · Other: Product C · Other: Product D · Other: Product E · Other: Product F · Other: Product G · Other: Product N
Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session
Other: Product A · Other: Product B · Other: Product C · Other: Product D · Other: Product E · Other: Product F · Other: Product G · Other: Product N
Subjects will use each of the 8 products during an evaluation period, followed by a 4 hour Test Session
Other: Product A · Other: Product B · Other: Product C · Other: Product D · Other: Product E · Other: Product F · Other: Product G · Other: Product N
Usual Brand (UB) filtered, menthol or non-menthol combustible cigarette
Modern Nicotine Oral Product Cool Mint 6 mg Nicotine
Modern Nicotine Oral Product Cool Mint 12 mg Nicotine
Modern Nicotine Oral Product Cool Mint 15 mg Nicotine
Modern Nicotine Oral Product Smooth 6 mg Nicotine
Modern Nicotine Oral Product Wintergreen 6 mg Nicotine
Modern Nicotine Oral Product Dragon Fruit 6 mg Nicotine
Nicorette® White Ice Mint 4 mg nicotine gum
AUECPL 5-240
area under the effect curve (AUEC) for PL (VAS score-versus-time)
Time frame: 5 minutes to 240 minutes
Emax PL
maximum effect (maximum PL VAS score after the start of IP use)
Time frame: 240 minutes
Plan to share: No
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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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