Abuse Liability for Five Modern Oral Nicotine Products
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-60
SponsorRAI Services Company
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.
Generally healthy males or females, 21 to 60 years of age, inclusive, at the time of consent.
Smokes combustible, filtered, non-menthol or menthol cigarettes, 83 mm to 100 mm in length as primary source of tobacco.
Smokes an average of at least 10 cigarettes per day (CPD) and inhales the smoke, for at least 6 months prior to Screening. Brief periods of abstinence due to illness, quit attempt (prior to 30 days of Screening), or clinical study participation (prior to 30 days of Screening) will be allowed at the discretion of an investigator.
Disqualifiers
Allergic to or cannot tolerate mint or wintergreen flavoring agents.
Individuals or their family members that have ongoing litigation with tobacco company(ies).
Have used electronic nicotine delivery system (e.g., Vuse Alto, JUUL) or tobacco heating device (e.g., iQOS) within the last 30 days prior to screening.
Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of an investigator, makes the study participant unsuitable to participate in this clinical study.
Trial design
Design model
Crossover
Treatments tested in this trial
Product A
Other interventionUsual Brand (UB) filtered, non-menthol or menthol combustible cigarette
Product B
Other intervention8 mg nicotine oral product
Product C
Other intervention12 mg nicotine oral product
Product D
Other intervention6 mg nicotine oral product
Product E
Other intervention8 mg nicotine oral product
Product F
Other intervention8 mg nicotine oral product
Product N
Other interventionNicorette® White Ice Mint 4 mg nicotine polacrilex gum
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Arm 1Experimental treatment 4 interventions
Group B: Arm 2Experimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
AUECPL 5-240
area under the effect curve (AUEC) for PL (VAS score-versus-time) from 5 minutes to 240 minutes after the start of IP use area under the effect curve (AUEC) for PL (VAS score-versus-time) from 5 minutes to 240 minutes after the start of IP use area under the effect curve (AUEC) for PL (VAS score-versus-time) from 5 minutes to 240 minutes after the start of IP use area under the effect curve (AUEC) for PL (VAS score-versus-time) from 5 minutes to 240 minutes after the start of IP use.
Time frame
5 minutes to 240 minutes2
Emax PL
maximum effect (maximum PL VAS score after the start of IP use)
Time frame
240 minutesSponsors and contacts
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Source ClinicalTrials.gov