The purpose of this study is to measure plasma nicotine uptake parameters, physiological measures, and subjective effect measures in smokers during and following a single ad libitum use of three electronic cigarettes versus combustible cigarettes and nicotine gum.
This study will assess various elements that may provide information regarding the potential for electronic cigarettes (e-cigarettes) to be adopted by current smokers. These various elements include: a) nicotine pharmacokinetics (PK), b) physiological measures of pulse rate and blood pressure, and c) subjective effects measured by Urge to Smoke, Product Rating, Intent to Use Product Again, and Product Effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
45
combustible cigarette brand style smoked most frequently by subject
VUSE® Digital Vapor Cigarette (original flavor, 14mg nicotine)
VUSE® Digital Vapor Cigarette (original flavor, 29mg nicotine)
Celerion
Lincoln, Nebraska, United States
Nicotine pharmacokinetics with respect to initiation of in-clinic investigational product (IP) use following a 12-hour tobacco and nicotine abstinence
Determine area under the plasma nicotine concentration versus time curve (AUC)
Time frame: -5, -0.5, 3, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes
Nicotine pharmacokinetics with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence
Determine maximum plasma nicotine concentration (Cmax), baseline adjusted
Time frame: -5, -0.5, 3, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes
Nicotine pharmacokinetics with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence
Determine time to baseline-adjusted maximum plasma nicotine concentration (Tmax)
Time frame: -5, -0.5, 3, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes
Subjective effects scores for Urge to Smoke (UTS) with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence
Score subjective effects using a numeric rating scale (NRS) to determine area under the UTS score-versus-time curve \[area under the effect curve (AUEC)\], minimum UTS score, and time to minimum UTS score
Time frame: -10, 5, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300, 360 minutes
Subjective effects scores for Intent to Use Again (IUA) with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence
Score subjective effects using a NRS to determine area under the IUA score-versus-time curve (AUEC) and maximum IUA score
Time frame: 15, 30, 45, 60, 120, 180, 240, 300, 360 minutes
Subjective effects scores for Product Ratings (PR) with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
VUSE® Digital Vapor Cigarette (original flavor, 36mg nicotine)
4 mg nicotine polacrilex gum
Score subjective effects using a NRS to determine area under the PR score-versus-time curve (AUEC) and maximum PR score
Time frame: 15, 30, 45, 60, 120, 180, 240, 300, 360 minutes
Subjective effects scores for positive Product Effects (PE) with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence
Score subjective effects using a NRS to determine area under the positive PE score-versus-time curve (AUEC) and maximum positive PE score
Time frame: 15, 30, 45, 60, 120, 180, 240, 300, 360 minutes
Subjective effects scores for negative Product Effects (PE) with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence
Score subjective effects using a NRS to determine area under the negative PE score-versus-time curve (AUEC) and maximum negative PE score
Time frame: 15, 30, 45, 60, 120, 180, 240, 300, 360 minutes
Maximum change in pulse rate relative to baseline
Determine the maximum change in pulse rate
Time frame: Baseline and at timed intervals over 360 minutes following initiation of IP use
Change in expired carbon monoxide (ECO) relative to baseline
Assess change in ECO from baseline following IP use
Time frame: Baseline and 35 minutes post-IP use
Baseline cotinine measured pre-IP use
Evaluate changes in baseline cotinine to assess whether subjects substantially changed their nicotine exposure during the study
Time frame: -0.5 minute only for each IP, over 5 weeks