Abuse Liability for Four Heated Tobacco Product (HTP) Consumables and Two HTP Devices
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, 8-way crossover 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 adult 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 (Arm 1 only) or menthol cigarettes (Arm 2 only), 83 mm to 100 mm in length as primary source of tobacco. Smokers who also use other tobacco products (e.g., ENDS, smokeless tobacco, HTPs) will not be excluded from study participation,
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 the PI.
Disqualifiers
Individuals or their family members that have ongoing litigation with tobacco company(ies).
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 the PI, makes the study participant unsuitable to participate in this clinical study.
History, presence of, or clinical laboratory test results indicating diabetes.
Scheduled treatment for asthma currently or within the past consecutive 12 months prior to the Screening Visit. As-needed treatment, such as inhalers, may be included at the PI's discretion.
Trial design
Design model
Crossover
Treatments tested in this trial
Product A
Other interventionUsual Brand filtered, non-menthol /menthol combustible cigarette
Product N
Other interventionNicorette White Ice Mint 4 mg
Product B
Other interventionSignature Tobacco, Standard Mode, Device 1
Product C
Other interventionSignature Tobacco, Boost Mode, Device 1
Product D
Other interventionRoasted Tobacco, Standard Mode, Device 1
Product E
Other interventionSignature Tobacco, Standard Mode, Device 2
Product F
Other interventionSignature Tobacco, Boost Mode, Device 2
Product G
Other interventionRoasted Tobacco, Standard Mode, Device 2
Product H
Other interventionFresh Menthol, Standard Mode, Device 1
Product I
Other interventionFresh Menthol, Boost Mode, Device 1
Product J
Other interventionMenthol Capsule (Crushed), Standard Mode, Device 1
Product K
Other interventionFresh Menthol, Standard Mode, Device 2
Product L
Other interventionFresh Menthol, Boost Mode, Device 2
Product M
Other interventionMenthol Capsule (Crushed), Standard Mode, Device 2
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: TobaccoExperimental treatment 8 interventions
Group B: MentholExperimental treatment 8 interventions
Trial outcomes
Primary outcomes
1
AUECPL 3-240
area under the curve (AUEC) for PL (VAS score-versus-time) from 3 minutes to 240 minutes after the start of IP use
Time frame
3 minutes to 240 minutes2
Emax PL
maximum effect (maximum PL VAS score after the start of IP use)
Time frame
240 minutesLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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