Nicotine Uptake and Abuse Liability Assessments of 5 Blu Disposable Electronic Cigarettes in Comparison to a Combustible Cigarette

Study Overview
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Brief Summary
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This study is being conducted to assess the abuse liability and puffing topography of blu disposable e-cigarettes in adult combustible cigarette smokers. Nicotine uptake, subjective effects, and puff topography will be evaluated and compared with subjects' usual brand combustible cigarette.

Official Title
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Nicotine Uptake and Abuse Liability Assessments of 5 Blu Disposable Electronic Cigarettes in Comparison to a Combustible Cigarette

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Other: Combustible Cigarette
* Other: blu Disposable A
* Other: blu Disposable B
* Other: blu Disposable C
* Other: blu Disposable D
* Other: blu Disposable E


Participation Criteria
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Eligibility Criteria
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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: Subjects who have used any nicotine or tobacco product other than e-cigarettes or combustible cigarettes in the 14 days prior to Visit 1 Subjects who have an acute illness requiring treatment in the 4 weeks prior to Visit 1 Subjects with clinically significant and relevant abnormalities of medical history. Subjects who have used any prescription or over-the-counter smoking cessation treatments within 30 days prior to Visit 1 Pregnant or breastfeading female subjects

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: blu Disposable Flavor A<br> | Other: blu Disposable A<br>* 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.<br>|
| Experimental: blu Disposable Flavor B<br> | Other: blu Disposable B<br>* 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.<br>|
| Experimental: blu Disposable Flavor C<br> | Other: blu Disposable C<br>* 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.<br>|
| Experimental: blu Disposable Flavor D<br> | Other: blu Disposable D<br>* 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.<br>|
| Experimental: blu Disposable Flavor E<br> | Other: blu Disposable E<br>* 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.<br>|
| Active Comparator: Combustible cigarette<br> | Other: Combustible Cigarette<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | at 15, 30, 45, and 60 minutes after the start of the ad libitum use session | 

Secondary Outcome Measures

| Outcome Measure | 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) |