Abuse Liability of Four Modern Oral Nicotine Products
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-60
SponsorRAI Services Company
About this trial
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.
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 and who also use MST. Participant's usual brand MST product needs to be a moist snuff tobacco product and not a Snus oral tobacco product.
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 (occurring 30 days prior to Screening), or clinical study participation (occurring 30 days prior to 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 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
Usual Brand (UB) filtered, menthol or non-menthol combustible cigarette
Other interventionUsual Brand (UB) filtered, menthol or non-menthol combustible cigarette
Wintergreen (fleece A), 12 mg nicotine
Other interventionWintergreen (fleece A), 12 mg nicotine
Wintergreen (fleece A), 9 mg nicotine
Other interventionWintergreen (fleece A), 9 mg nicotine
Wintergreen (fleece B), 9 mg Nicotine
Other interventionWintergreen (fleece B), 9 mg Nicotine
Watermelon Mint (fleece A), 9 mg Nicotine
Other interventionWatermelon Mint (fleece A), 9 mg Nicotine
UB moist snuff (UB MST), either loose or portioned (pouched).
Other interventionUB moist snuff (UB MST), either loose or portioned (pouched).
Treatment groups
50 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Product usage order ASDECBExperimental treatment 6 interventions
Group B: Product usage order BAESDCExperimental treatment 6 interventions
Group C: Product usage order CBSAEDExperimental treatment 6 interventions
Group D: Product usage order DCABSEExperimental treatment 6 interventions
Group E: Product usage order EDBCASExperimental treatment 6 interventions
Group F: Product usage order SECDBAExperimental treatment 6 interventions
Trial outcomes
Primary outcomes
1
AUECPL 5-60
area under the effect curve (AUEC) for PL (VAS score-versus-time)
Time frame
5 minutes to 60 minutes2
Emax PL
maximum effect (maximum PL VAS score after the start of IP use)
Time frame
60 minutesLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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