This study assessed the abuse liability (measured by assessing how much nicotine enters the body when the BIDI Stick is used, and how this makes users feel) and puffing topography (puff characteristics like volume and duration) of the BIDI Stick ENDS, a type of electronic cigarette.
This is a part-randomized, open label abuse liability assessment (ALA) and puffing topography study of nicotine-containing products carried out in 18 healthy adult volunteers who smoke combustible cigarettes. Subjects will attend the study site 8 times (Visits 2-9) during the main study for ALA and puff topography assessments. Prior to each visit, subjects will be required to refrain from using any nicotine-containing products for a period of at least 12 hours before study product use. At Visit 2, the subjects will smoke their usual brand cigarette during 2 use sessions. In the first session, subjects will smoke a single combustible cigarette of their usual brand by taking 10 puffs, 30 seconds apart. Blood samples will be obtained for plasma nicotine analysis, and blood pressure and heart rate will be recorded. Subjects will be asked to complete subjective effects questionnaires at various points either before, during, or after product use. In the second session, which will begin immediately after the last blood draw following the first session and after all questionnaires have been completed, subjects will be allowed to take ad libitum puffs on their usual brand cigarette for a period of 60 minutes (1 hour). In a randomly-selected subset of 8 subjects, during this ad libitum puffing session puffing topography measurements will be made with a CReSS Pocket device. Subjects may smoke as many cigarettes as they like. In all subjects, a blood sample for nicotine PK analysis will be drawn at the end of the session. Blood pressure and heart rate will be recorded at this time. Subjective effects questionnaires will also be completed at specified timepoints. At Visits 3-9, the subjects will use their randomly-assigned ENDS product during 2 use sessions. These use sessions, and the assessments made, will be the same as at visit 2. Prior to visit 3-9, subjects will be provided with a supply of their randomly-assigned product to use at home before their next visit (familiarization). This familiarization period should last a minimum of 2 and a maximum of 5 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
18
Products will be used under defined (10 puffs, 30 seconds apart) and ad libitum puffing conditions
MTZ Clinical Research Sp. z o.o.
Warsaw, Poland
Baseline-adjusted plasma nicotine Cmax0-120
Maximum baseline-adjusted plasma concentration of nicotine from time zero to 120 minutes after the start of product use
Time frame: 0-120 minutes
Baseline-adjusted plasma nicotine Tmax0-120
Baseline-adjusted plasma nicotine Tmax following defined product use
Time frame: 0-120 minutes
Baseline-adjusted plasma nicotine AUC0-120
Baseline-adjusted area under the plasma nicotine concentration-versus-time curve from time zero to 120 minutes after the start of product use
Time frame: 0-120 minutes
Baseline-adjusted plasma nicotine Cmax0-180
Maximum baseline-adjusted plasma concentration of nicotine from time zero to 180 minutes after the start of product use
Time frame: 0-180 minutes
Baseline-adjusted plasma nicotine Tmax0-180
Baseline-adjusted plasma nicotine Tmax following both defined and ad libitum product use
Time frame: 0-180 minutes
Baseline-adjusted plasma nicotine AUC0-180
Baseline-adjusted area under the plasma nicotine concentration-versus-time curve from time zero to 180 minutes after the start of product use
Time frame: 0-180 minutes
Product liking
Visual analog scale product liking assessment; scale from 0 to 100 with higher scores representing stronger liking.
Time frame: 180 minutes
Intent to Use Product Again
Visual analog scale intent to use product again assessment; scale from 0 to 100 with higher scores representing stronger intent to use the product again.
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Time frame: 180 minutes
Urge to Smoke
Visual analog scale urge to smoke assessment; scale from 0 to 100 with higher scores representing stronger urge to smoke.
Time frame: 0-180 minutes
Product Evaluation Scale
Subjective effects assessment using Product Evaluation Scale, which included 21 items with responses recorded on a scale of 1 to 7 ranging from 'Not at all' to 'Extremely'.
Time frame: 180 minutes
Mass change
Mass change in grams of ENDS products during use sessions
Time frame: 0-5 minutes and 120-180 minutes
Puff duration
Puff duration from puffing topography measurements
Time frame: 120-180 minutes
Puff volume
Puff volume from puffing topography measurements
Time frame: 120-180 minutes
Peak puff flow rate
Peak puff flow rate from puffing topography measurements
Time frame: 120-180 minutes
Average puff flow rate
Average puff flow rate from puffing topography measurements
Time frame: 120-180 minutes
Inter-puff interval
Time between puffs from puffing topography measurements
Time frame: 120-180 minutes