Abuse Liability for Eight Electronic Nicotine Products
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-60
SponsorRAI Services Company
About this trial
This will be a randomized, open-label, 8-way crossover, single-site 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 Electronic Nicotine Delivery System (ENDS) investigational products (IPs) in a confinement setting by generally healthy adult smokers of combustible cigarettes and dual users of cigarettes and ENDS products.
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 male or female, 21 to 60 years of age, inclusive, at the time of consent.
Expired breath carbon monoxide level is ≥ 10 ppm and ≤ 100 ppm at Screening.
Positive (≥200 ng/ml) urine cotinine test at Screening.
Disqualifiers
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.
Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg, measured after being seated for five minutes at Screening and at check-in Day 1.
Weight of ≤ 110 pounds at Screening.
Trial design
Design model
Crossover
Treatments tested in this trial
Product A
Other interventionUsual Brand (UB) filtered, menthol or non-menthol combustible cigarette
Product B
Other interventionTobacco Flavor, 5%
Product C
Other interventionTobacco Flavor, 1.5%
Product D
Other interventionTobacco Flavor, 5%
Product E
Other interventionTobacco Flavor, 2.4%
Product F
Other interventionTobacco Flavor, 5%
Product G
Other interventionMint Flavor, 5%
Product N
Other interventionNicorette® White Ice Mint 4 mg nicotine polacrilex gum
Treatment groups
70 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Product usage order ANBGCFDEExperimental treatment 8 interventions
Group B: Product usage order BACNDGEFExperimental treatment 8 interventions
Group C: Product usage order CBDAENFGExperimental treatment 8 interventions
Group D: Product usage order DCEBFAGNExperimental treatment 8 interventions
Group E: Product usage order EDFCGBNAExperimental treatment 8 interventions
Group F: Product usage order FEGDNCABExperimental treatment 8 interventions
Group G: Product usage order GFNEADBCExperimental treatment 8 interventions
Group H: Product usage order NGAFBECDExperimental treatment 8 interventions
Trial outcomes
Primary outcomes
1
AUECPL 3-240
area under the effect curve (AUEC) for PL (VAS score-versus-time)
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
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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