Abuse Liability of Two Modern Oral Nicotine Pouched 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, 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.
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 ST (e.g., moist snuff).
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 or tobacco heating device 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
Modern Oral Pouch Wintergreen-A 9 mg Nicotine
Other intervention-A 9 mg Nicotine
Modern Oral Pouch Wintergreen-B 9 mg Nicotine
Other intervention-B 9 mg Nicotine
UB loose or pouched moist snuff
Other interventionUB loose or pouched moist snuff
Treatment groups
40 Participants
are divided into 4 treatment groupsGroup A: Product usage order ASBCExperimental treatment 4 interventions
Group B: Product usage order BACSExperimental treatment 4 interventions
Group C: Product usage order CBSAExperimental treatment 4 interventions
Group D: Product usage order SCABExperimental treatment 4 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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