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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Product Use Sequence 1 | Experimental | Period 1 - RELX ENDS Tobacco Flavor Period 2 - RELX ENDS Menthol Flavor Period 3 - Nicorette White Ice Mint Nicotine Polacrilex Gum Period 4 - Usual Brand Cigarette |
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| Product Use Sequence 2 | Experimental | Period 1 - RELX ENDS Menthol Flavor Period 2 - Usual Brand Cigarette Period 3 - RELX ENDS Tobacco Flavor Period 4 - Nicorette White Ice Mint Nicotine Polacrilex Gum |
|
| Product Use Sequence 3 | Experimental | Period 1 - Usual Brand Cigarette Period 2 - Nicorette White Ice Mint Nicotine Polacrilex Gum Period 3 - RELX ENDS Menthol Flavor Period 4 - RELX ENDS Tobacco Flavor |
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| Product Use Sequence 4 | Experimental | Period 1 - Nicorette White Ice Mint Nicotine Polacrilex Gum Period 2 - RELX ENDS Tobacco Flavor Period 3 - Usual Brand Cigarette Period 4 - RELX ENDS Menthol Flavor |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RELX ENDS Tobacco Flavor | Other | Ad libitum use of RELX ENDS tobacco flavor product during 8-hour and 5-minute use sessions |
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| 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] |
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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 smoker for at least 12 months prior to Screening and through check-in. Brief periods of non-smoking (e.g., up to ~7 consecutive days due to illness, trying to quit, participation in a study where smoking was prohibited) ≥ 30 days prior to Screening will be permitted at the discretion of the Investigator.
Reports typically smoking 10 combustible cigarettes (king size or 100s) per day at Screening.
Has a urine cotinine concentration ≥ 200 ng/mL at Screening and Check-in.
Has an exhaled carbon monoxide (ECO) concentration > 10 ppm at Screening and 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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Donald Graff, PharmD | Sponsor Representative | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences Clinical Kansas, Inc | Overland Park | Kansas | 66212 | United States |
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| RELX ENDS Menthol Flavor | Other | Ad libitum use of RELX ENDS Menthol flavor product during 8-hour and 5-minute use sessions |
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| Usual Brand Cigarette | Other | Ad libitum use of subjects usual brand product during 8-hour and single cigarette use sessions |
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| Nicorette White Ice Mint nicotine polacrilex gum | Other | Ad libitum use of Nicorette White Ice Mint nicotine polacrilex gum product during 8-hour and 30-minute use sessions |
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| 120 minutes |
| Nicotine Uptake - Ad Libitum Session | Ad Libitum Session baseline-adjusted area under the nicotine concentration-time curve [AUC(0-480)] | 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] | 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") | 480 minutes |
| 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") | 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") | 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 |
| Carbon Monoxide Exposure | Change in exhaled carbon monoxide during the PK Session | 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 | 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) | 480 minutes |
| Study Product Use | Number of puffs taken from the RELX ENDS and cigarette during the Ad Libitum Session topography assessment | 60 minutes |
| Study Product Use | Duration of puffs taken from the RELX ENDS and cigarette during the Ad Libitum Session topography assessment | 60 minutes |
| Study Product Use | Volume of puffs taken from the RELX ENDS and cigarette during the Ad Libitum Session topography assessment | 60 minutes |
| Study Product Use | Flow rate of puffs taken from the RELX ENDS and cigarette during the Ad Libitum Session topography assessment | 60 minutes |
| Study Product Use | Inter-puff interval of puffs taken from the RELX ENDS and cigarette during the Ad Libitum Session topography assessment | 60 minutes |
| Study Product Use | Pre- to post-use RELX pod weight difference during the PK Session | 5 minutes |
| Study Product Use | Number of puffs from the RELX ENDS and cigarettes during the PK Session | 5 minutes |
| Incidence of product-use emergent adverse events [Safety and Tolerability] | Incidence of product-use emergent adverse events | 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 | 24 hours |
| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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