Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is being conducted to evaluate nicotine uptake, the potential 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 ENDS consumers.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Product Use Sequence 1 | Experimental | Products use sequence: Period 1 - RELX ENDS tobacco flavor Period 2 - RELX ENDS menthol flavor Period 3 - Usual Brand ENDS |
|
| Product Use Sequence 2 | Experimental | Products use sequence: Period 1 - RELX ENDS menthol flavor Period 2 - Usual Brand ENDS Period 3 - RELX ENDS tobacco flavor |
|
| Product Use Sequence 3 | Experimental | Products use sequence: Period 1 - Usual Brand ENDS Period 2 - RELX ENDS tobacco flavor Period 3 - RELX ENDS menthol flavor |
|
| Product Use Sequence 4 | Experimental | Products use sequence: Period 1 - Usual Brand ENDS Period 2 - RELX ENDS menthol flavor Period 3 - RELX ENDS tobacco flavor |
|
| Product Use Sequence 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RELX ENDS Tobacco Flavor | Other | Ad libitum use of the RELX ENDS tobacco flavor product during 8-hour and 5-minute use sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nicotine uptake | PK Session baseline-adjusted maximum plasma nicotine concentration [Cmax] | 120 minutes |
| Nicotine uptake | PK Session baseline-adjusted area under the nicotine concentration-time curve [AUC(0-120)] | 120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Nicotine uptake - PK Session | PK Session baseline-adjusted area under the nicotine concentration-time curve [AUC(0-15)] | 15 minutes |
| Nicotine uptake - PK Session | PK Session time of the maximum post-baseline nicotine concentration [Tmax] |
Not provided
Inclusion Criteria:
Provides voluntary consent to participate in the study as documented on the signed informed consent form (ICF).
Is 22 to 59 years of age, inclusive, at the time of consent.
Has been a daily ENDS consumer for at least 3 months prior to Screening and through Check-in. Brief periods of abstinence (e.g., up to ~7 consecutive days due to illness, trying to quit, participation in a study where vaping was prohibited) ≥ 30 days prior to Screening will be permitted at the discretion of an Investigator.
Reports weekly use of at least 3 mL of e-liquid from an ENDS product at Screening.
Has a urine cotinine concentration ≥ of 200 ng/mL at Screening and Check-in.
Has an exhaled carbon monoxide (ECO) concentration < 10 ppm at Check-in.
If female, must meet one of the following criteria:
If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 30 days prior to the first product use, during the study, and for at least 30 days after the last product use. An acceptable method of contraception includes one of the following: abstinence from heterosexual intercourse, hormonal contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch), intrauterine device (with or without hormones) OR agrees to use a double barrier method (e.g. condom and spermicide) during the study and for at least 30 days after the last product use.
If a female of non-childbearing potential - should be surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation/occlusion) or in a menopausal state (at least 1 year without menses), as confirmed by FSH levels (≥ 40 mIU/mL).
Is willing to comply with the requirements of the study.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Donald Graff, PharmD | Sponsor Representative | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WCCT Global, Inc | Cypress | California | 90630 | United States | ||
| Altasciences Clinical Kansas, Inc |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Products use sequence: Period 1 - RELX ENDS tobacco flavor Period 2 - Usual Brand ENDS Period 3 - RELX ENDS menthol flavor |
|
| Product Use Sequence 6 | Experimental | Products use sequence: Period 1 - RELX ENDS menthol flavor Period 2 - RELX ENDS tobacco flavor Period 3 - Usual Brand ENDS |
|
| RELX ENDS Menthol Flavor | Other | Ad libitum use of the RELX ENDS tobacco flavor product during 8-hour and 5-minute use sessions |
|
| Subject Usual Brand ENDS | Other | Ad libitum use of the usual brand product during 8-hour and 5-minute use sessions |
|
| 120 minutes |
| Nicotine uptake - Ad Libitum Session | Ad Libitum Session baseline-adjusted area under the nicotine concentration-time curve [AUC(0-480)] | 480 minutes |
| Subject 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]) | 480 minutes |
| Subject 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 analog scale range of "Definitely Would Not" to "Definitely Would") | 480 minutes |
| Subject effects as measured by the Urge to Vape questionnaire | Subjective product assessments during the PK Session as measured by responses to the Urge to Vape questionnaire (visual analog scale range of "Not at All" to "Extreme") | 120 minutes |
| Subject 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") | 120 minutes |
| Physiologic effects as measured by heart rate | Heart rate measurements during the Ad Libitum Session | 480 minutes |
| Physiologic effects as measured by heart rate | Heart rate measurements during the PK Session | 120 minutes |
| Physiologic effects as measured by blood pressure | Blood pressure measurements during the Ad Libitum Session | 480 minutes |
| Physiologic effects as measured by blood pressure | Blood pressure measurements during the PK Session | 120 minutes |
| Study product use | Change in weight of study products during the Ad Libitum Session | 480 minutes |
| Study product use | Number of requests to use the study products during the Ad Libitum Session | 480 minutes |
| Study product use | Number of puffs taken from the study products during the Ad Libitum Session topography assessment | 60 minutes |
| Study product use | Duration of puffs taken from the study products during the Ad Libitum Session topography assessment | 60 minutes |
| Study product use | Volume of puffs taken from the study products during the Ad Libitum Session topography assessment | 60 minutes |
| Study product use | Flow rate of puffs taken from the study products during the Ad Libitum Session topography assessment | 60 minutes |
| Study product use | Inter-puff interval of puffs taken from the study products during the Ad Libitum Session topography assessment | 60 minutes |
| Study product use | Change in weight of study products during the PK Session | 5 minutes |
| Study product use | Number of puffs taken from the study products during the PK Session | 5 minutes |
| Safety and tolerability | Incidence of product-use emergent adverse events | 24 hours |
| Safety and tolerability | Incidence of product malfunction or misuse | 24 hours |
| Overland Park |
| Kansas |
| 66212 |
| United States |
| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
Not provided
Not provided