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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05134415
Other study ID # RELX-004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 12, 2021
Est. completion date December 1, 2021

Study information

Verified date December 2021
Source Cheerain HK Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


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Study Design


Related Conditions & MeSH terms


Intervention

Other:
RELX ENDS Tobacco Flavor 1
2-week ad libitum use of the RELX ENDS tobacco flavor 1
RELX ENDS Tobacco Flavor 2
2-week ad libitum use of the RELX ENDS tobacco flavor 2
RELX ENDS Menthol Flavor 1
2-week ad libitum use of the RELX ENDS menthol flavor 1
RELX ENDS Menthol Flavor 2
2-week ad libitum use of the RELX ENDS menthol flavor 2

Locations

Country Name City State
United States Los Angeles Clinical Trials Burbank California

Sponsors (1)

Lead Sponsor Collaborator
Cheerain HK Limited

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Study product use - daily pod use The number of pods used per day during the 14-day ambulatory period 14 days
Secondary Study product use - e-liquid consumption per pod The amount of e-liquid consumed per pod during the 14-day ambulatory period 14 days
Secondary Study product use - e-liquid consumption per day The amount of e-liquid consumed each day during the 14-day ambulatory period 14 days
Secondary Puff topography - number of puffs Number of puffs taken from the study products during the PK Session 5 minutes
Secondary Puff topography - duration of puffs Duration of puffs taken from the study products during the PK Session 5 minutes
Secondary Puff topography - volume of puffs Volume of puffs taken from the study products during the PK Session 5 minutes
Secondary Puff topography - peak flow rate of puffs Peak flow rate of puffs taken from the study products during the PK Session 5 minutes
Secondary Puff topography - average flow rate of puffs Average flow rate of puffs taken from the study products during the PK Session 5 minutes
Secondary Puff topography - inter-puff interval Inter-puff interval of puffs taken from the study products during the PK Session 5 minutes
Secondary Study product use - e-liquid consumption (PK session) Change in pod weight of pods used during the PK Session 5 minutes
Secondary 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. 14 days
Secondary 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]. 14 days
Secondary 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]). 14 days
Secondary 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]. 14 days
Secondary 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]. 14 days
Secondary 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") 30 minutes
Secondary 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") 30 minutes
Secondary 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") 30 minutes
Secondary Nicotine uptake - maximum nicotine concentration Baseline-adjusted maximum plasma nicotine concentration [Cmax] 30 minutes
Secondary Nicotine uptake - overall nicotine uptake Baseline-adjusted area under the nicotine concentration-time curve [AUC(0-30)] 30 minutes
Secondary Nicotine uptake - time to maximum nicotine concentration Time of the maximum post-baseline nicotine concentration [Tmax] 30 minutes
Secondary Safety and tolerability - adverse events Incidence of product-use emergent adverse events 14 days
Secondary Safety and tolerability - product malfunction or misuse Incidence of product malfunction or misuse 14 days
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