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This study assesses the nicotine uptake, abuse liability and puffing topography of blu disposable e-cigarettes in adult combustible cigarette smokers. Nicotine uptake, subjective effects, and puff topography are evaluated and compared with subjects' usual brand combustible cigarette.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| blu Disposable Flavor A | Experimental | Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor A |
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| blu Disposable Flavor B | Experimental | Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor B |
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| blu Disposable Flavor C | Experimental | Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor C |
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| blu Disposable Flavor D | Experimental | Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor D |
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| blu Disposable Flavor E | Experimental | Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor E |
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| Combustible cigarette | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combustible Cigarette | Other | Subjects smoke their Usual Brand Combustible Cigarette, for 2 consecutive product use sessions. 1. Defined session: 10 puffs, each 30 seconds apart. 2. Ad libitum session: 60 minutes ad-libitum use. |
| Measure | Description | Time Frame |
|---|---|---|
| Nicotine Cmax0-120 | Maximum plasma nicotine concentration, during the defined use session, adjusted for baseline nicotine | 5 minutes before and at 3, 5, 7, 10, 15, 20, 30, 45, 60, 90, and 120 minutes after the first puff |
| Nicotine Cmax120-180 | Maximum plasma nicotine concentration during the ad libitum use session, adjusted for baseline nicotine | at 15, 30, 45, and 60 minutes after the start of the ad libitum use session (ad libitum session starts at 120 min relative to first puff of controlled use session) |
| Nicotine AUC0-120 | Area under the plasma nicotine concentration-time curve from time 0 to 120 minutes during the defined use session | 5 minutes before and at 3, 5, 7, 10, 15, 20, 30, 45, 60, 90, and 120 minutes after the first puff |
| Nicotine AUC120-180 | Area under the plasma nicotine concentration-time curve from time 120 minutes to 180 minutes, i.e. during the ad libitum use session | at 15, 30, 45, and 60 minutes after the start of the ad libitum use session |
| Urge to Smoke - Defined use | Subjects answer "How strong is your current urge to smoke your usual brand cigarette?" on a Visual Analog Scale: from "No Urge" at the left to "Very Strong Urge" at the right. | 5 minutes before and at 3, 5, 7, 10, 15, 20, 30, 45, 60, 90, and 120 minutes after the first puff |
| Urge to Smoke - Ad libitum use | Subjects answer "How strong is your current urge to smoke your usual brand cigarette?" on a Visual Analog Scale: from "No Urge" at the left to "Very Strong Urge" at the right. |
| Measure | Description | Time Frame |
|---|---|---|
| Puff topography: puff count | Measured during the ad libitum use session with a CReSS Pocket topography device | Throughout ad libitum use session (60 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcome: heart rate after defined use | Heart rate after the subject has spent at least 5 minutes in the seated position | At 8 minutes relative to first puff of defined use session |
| Safety Outcome: heart rate after ad libitum use |
Inclusion Criteria:
Subjects must be current smokers (≥10 per day) of combustible cigarettes for at least 6 continuous months before Visit 1 and may be occasional users of e-cigarettes
Subjects have urine cotinine >200 ng/mL and exhaled carbon monoxide > 10 ppm at Screening
Subject has a seated systolic blood pressure ≤160 mmHg, diastolic blood pressure
≤95 mmHg, and heart rate ≤100 bpm
Females of childbearing potential who are practicing a reliable method of contraception
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LA Clinical Trials, LLC | Burbank | California | 91505 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 13, 2021 | Sep 2, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 2, 2021 | Sep 2, 2024 | SAP_001.pdf |
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Subjects who use their own brand of combustible cigarette |
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| blu Disposable A | Other | Subjects use the blu disposable e-cigarette with flavor A, 2.4% nicotine, for 2 consecutive product use sessions. 1. Defined session: 10 puffs, each 30 seconds apart. 2. Ad libitum session: 60 minutes ad-libitum use. |
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| blu Disposable B | Other | Subjects use the blu disposable e-cigarette with flavor B, 2.4% nicotine, for 2 consecutive product use sessions. 1. Defined session: 10 puffs, each 30 seconds apart. 2. Ad libitum session: 60 minutes ad-libitum use. |
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| blu Disposable C | Other | Subjects use the blu disposable e-cigarette with flavor C, 2.4% nicotine, for 2 consecutive product use sessions. 1. Defined session: 10 puffs, each 30 seconds apart. 2. Ad libitum session: 60 minutes ad-libitum use. |
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| blu Disposable D | Other | Subjects use the blu disposable e-cigarette with flavor D, 2.4% nicotine, for 2 consecutive product use sessions. 1. Defined session: 10 puffs, each 30 seconds apart. 2. Ad libitum session: 60 minutes ad-libitum use. |
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| blu Disposable E | Other | Subjects use the blu disposable e-cigarette with flavor E, 2.4% nicotine, for 2 consecutive product use sessions. 1. Defined session: 10 puffs, each 30 seconds apart. 2. Ad libitum session: 60 minutes ad-libitum use. |
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| at 15, 30, 45, and 60 minutes after the start of the ad libitum use session |
Heart rate after the subject has spent at least 5 minutes in the seated position
| At 60 minutes relative to first puff of ad libitum use session |
| Safety Outome: systolic blood pressure after defined use | Blood pressure measured after the subject has spent at least 5 minutes in the seated position | At 8 minutes relative to first puff of defined use session |
| Safety Outome: systolic blood pressure after ad libitum use | Blood pressure measured after the subject has spent at least 5 minutes in the seated position | At 60 minutes relative to first puff of ad libitum use session |
| Safety Outome: diastolic blood pressure after defined use | Blood pressure measured after the subject has spent at least 5 minutes in the seated position | At 8 minutes relative to first puff of defined use session |
| Safety Outome: diastolic blood pressure after ad libitum use | Blood pressure measured after the subject has spent at least 5 minutes in the seated position | At 60 minutes relative to first puff of ad libitum use session |