This study is being conducted to evaluate nicotine uptake and exposure, the abuse liability, and puffing topography associated with the use of an electronic nicotine delivery system ENDS with tobacco- and menthol-flavored e-liquids in current smokers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
41
Ad libitum use of RELX ENDS tobacco flavor product during 8-hour and 5-minute use sessions
Ad libitum use of RELX ENDS Menthol flavor product during 8-hour and 5-minute use sessions
Ad libitum use of subjects usual brand product during 8-hour and single cigarette use sessions
Altasciences Clinical Kansas, Inc
Overland Park, Kansas, United States
Nicotine Uptake
PK Session baseline-adjusted maximum plasma nicotine concentration \[Cmax\]
Time frame: 120 minutes
Nicotine Uptake
PK Session baseline-adjusted area under the nicotine concentration-time curve \[AUC(0-120)\]
Time frame: 120 minutes
Nicotine Uptake - PK Session
PK Session baseline-adjusted area under the nicotine concentration-time curve \[AUC(0-15)\]
Time frame: 15 minutes
Nicotine Uptake - PK Session
PK Session time of the maximum post-baseline nicotine concentration \[Tmax\]
Time frame: 120 minutes
Nicotine Uptake - Ad Libitum Session
Ad Libitum Session baseline-adjusted area under the nicotine concentration-time curve \[AUC(0-480)\]
Time frame: 480 minutes
Subjective Effects as measured by the Modified Product Evaluation Scale
Subjective product assessments during the Ad Libitum Session as measured by responses to the Modified Product Evaluation Scale (scale range of 1 \[not at all\] to 7 \[extremely\]
Time frame: 480 minutes
Subjective effects as measured by the Future Intent to Use questionnaire
Subjective product assessments during the Ad Libitum Session as measured by responses to the Future Intent to Use questionnaire (visual annalog scale range of "Definitely Would Not" to " Definitely Would")
Time frame: 480 minutes
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Ad libitum use of Nicorette White Ice Mint nicotine polacrilex gum product during 8-hour and 30-minute use sessions
Subjective Effects as measured by the Urge to Smoke questionnaire
Subjective product assessments during the PK Session as measured by responses to the Urge to Smoke questionnaire (visual analog scale range of "Not at All" to "Extreme")
Time frame: 120 minutes
Subjective Effects as measured by the Product Liking questionnaire
Subjective product assessments during the PK Session as measured by responses to the Product Liking questionnaire (visual analog scale range of "Not at All" to "Extremely")
Time frame: 120 minutes
Physiologic effects as measured by heart rate
Heart rate measurements during the Ad Libitum Session
Time frame: 480 minutes
Physiologic effects as measured by heart rate
Heart rate measurements during the PK Session
Time frame: 120 minutes
Physiologic effects as measured by blood pressure
Blood pressure measurements during the Ad Libitum Session
Time frame: 480 minutes
Physiologic effects as measured by blood pressure
Blood pressure measurements during the PK Session
Time frame: 120 minutes
Carbon Monoxide Exposure
Change in exhaled carbon monoxide during the PK Session
Time frame: 25 minutes (50 minutes for the nicotine gum period)
Study Product Use
Change in weight of the RELX study products during the Ad Libitum Session
Time frame: 480 minutes
Study Product Use
Number of requests to use the study products during the Ad Libitum Session (requests to use the RELX ENDS product, number of cigarettes smoked, number of pieces of gum used)
Time frame: 480 minutes
Study Product Use
Number of puffs taken from the RELX ENDS and cigarette during the Ad Libitum Session topography assessment
Time frame: 60 minutes
Study Product Use
Duration of puffs taken from the RELX ENDS and cigarette during the Ad Libitum Session topography assessment
Time frame: 60 minutes
Study Product Use
Volume of puffs taken from the RELX ENDS and cigarette during the Ad Libitum Session topography assessment
Time frame: 60 minutes
Study Product Use
Flow rate of puffs taken from the RELX ENDS and cigarette during the Ad Libitum Session topography assessment
Time frame: 60 minutes
Study Product Use
Inter-puff interval of puffs taken from the RELX ENDS and cigarette during the Ad Libitum Session topography assessment
Time frame: 60 minutes
Study Product Use
Pre- to post-use RELX pod weight difference during the PK Session
Time frame: 5 minutes
Study Product Use
Number of puffs from the RELX ENDS and cigarettes during the PK Session
Time frame: 5 minutes
Incidence of product-use emergent adverse events [Safety and Tolerability]
Incidence of product-use emergent adverse events
Time frame: 24 hours
Incidence of product malfunction or misuse of the RELX ENDS [Safety and Tolerability]
Incidence of product malfunction or misuse of the RELX ENDS
Time frame: 24 hours