This study is being conducted to evaluate the impact of within-flavor category (tobacco and menthol) differences in e-liquid flavors on product use behaviors, nicotine uptake, and subjective effects by current ENDS consumers when used in a closed-system electronic nicotine delivery system (ENDS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
40
2-week ad libitum use of the RELX ENDS tobacco flavor 1
2-week ad libitum use of the RELX ENDS tobacco flavor 2
2-week ad libitum use of the RELX ENDS menthol flavor 1
Los Angeles Clinical Trials
Burbank, California, United States
Study product use - daily pod use
The number of pods used per day during the 14-day ambulatory period
Time frame: 14 days
Study product use - e-liquid consumption per pod
The amount of e-liquid consumed per pod during the 14-day ambulatory period
Time frame: 14 days
Study product use - e-liquid consumption per day
The amount of e-liquid consumed each day during the 14-day ambulatory period
Time frame: 14 days
Puff topography - number of puffs
Number of puffs taken from the study products during the PK Session
Time frame: 5 minutes
Puff topography - duration of puffs
Duration of puffs taken from the study products during the PK Session
Time frame: 5 minutes
Puff topography - volume of puffs
Volume of puffs taken from the study products during the PK Session
Time frame: 5 minutes
Puff topography - peak flow rate of puffs
Peak flow rate of puffs taken from the study products during the PK Session
Time frame: 5 minutes
Puff topography - average flow rate of puffs
Average flow rate of puffs taken from the study products during the PK Session
Time frame: 5 minutes
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2-week ad libitum use of the RELX ENDS menthol flavor 2
Puff topography - inter-puff interval
Inter-puff interval of puffs taken from the study products during the PK Session
Time frame: 5 minutes
Study product use - e-liquid consumption (PK session)
Change in pod weight of pods used during the PK Session
Time frame: 5 minutes
Subjective effects - dependence
Nicotine dependence as measured by the Penn State Electronic Cigarette Dependence Index (PSECDI) total score. Total scores may range from 0 to 20, with higher levels of dependence associated with higher scores.
Time frame: 14 days
Subjective effects - craving
Craving as measured by the Questionnaire of Vaping Craving (QVC) average score. Questionnaire responses are measured on a Likert scale range of 1 \[strongly disagree\] to 7 \[strongly agree\].
Time frame: 14 days
Subjective effects - withdrawal symptoms
Withdrawal symptoms as measured by the Minnesota Tobacco Withdrawal Scale - Revised (MTWS-R), which includes the DSM-5 and craving items from the MTWS. Questionnaire responses are measured on a Likert scale range of 0 \[none\] to 4 \[severe\]).
Time frame: 14 days
Subjective effects - product effects
Product effects as measured by the Modified Product Evaluation Scale (mPES) satisfaction, psychological reward, aversion, and relief subscale and individual item scores. Questionnaire responses are measured on a Likert scale range of 1 \[not at all\] to 7 \[extremely\].
Time frame: 14 days
Subjective effects - future intent to use product
Future intent to use the product as measured by the Future Intent to Use Questionnaire (FIU). Questionnaire responses are measured on a Likert scale range of 1 \[extremely unlikely\] to 7 \[extremely likely\].
Time frame: 14 days
Subjective effects - maximum acute urge to vape reduction
Maximum urge to vape reduction (Emax\_R) as measured by responses to the Urge to Vape questionnaire (visual analog scale range of "Not at All" to "Extreme")
Time frame: 30 minutes
Subjective effects - overall acute urge to vape reduction
Overall urge to vape reduction (AOEC0-30) as measured by responses to the Urge to Vape questionnaire (visual analog scale range of "Not at All" to "Extreme")
Time frame: 30 minutes
Subjective effects - time to maximum acute urge to vape reduction
Time to the maximum urge to vape reduction (TEmax\_R) as measured by responses to the Urge to Vape questionnaire (visual analog scale range of "Not at All" to "Extreme")
Time frame: 30 minutes
Nicotine uptake - maximum nicotine concentration
Baseline-adjusted maximum plasma nicotine concentration \[Cmax\]
Time frame: 30 minutes
Nicotine uptake - overall nicotine uptake
Baseline-adjusted area under the nicotine concentration-time curve \[AUC(0-30)\]
Time frame: 30 minutes
Nicotine uptake - time to maximum nicotine concentration
Time of the maximum post-baseline nicotine concentration \[Tmax\]
Time frame: 30 minutes
Safety and tolerability - adverse events
Incidence of product-use emergent adverse events
Time frame: 14 days
Safety and tolerability - product malfunction or misuse
Incidence of product malfunction or misuse
Time frame: 14 days