Healthy Volunteers
Conditions
Brief summary
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.
Interventions
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.
OTHERblu Disposable A
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.
OTHERblu Disposable B
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.
OTHERblu Disposable C
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.
OTHERblu Disposable D
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.
OTHERblu Disposable E
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.
Sponsors
Fontem US LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
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 breastfeeding female subjects
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nicotine Cmax0-120 | 5 minutes before and at 3, 5, 7, 10, 15, 20, 30, 45, 60, 90, and 120 minutes after the first puff | Maximum plasma nicotine concentration, during the defined use session, adjusted for baseline nicotine |
| Urge to Smoke - Ad libitum use | at 15, 30, 45, and 60 minutes after the start of the ad libitum use session | 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. |
| Urge to Smoke - Defined use | 5 minutes before and at 3, 5, 7, 10, 15, 20, 30, 45, 60, 90, and 120 minutes after the first puff | 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. |
| Nicotine AUC120-180 | at 15, 30, 45, and 60 minutes after the start of the ad libitum use session | Area under the plasma nicotine concentration-time curve from time 120 minutes to 180 minutes, i.e. during the ad libitum use session |
| Nicotine AUC0-120 | 5 minutes before and at 3, 5, 7, 10, 15, 20, 30, 45, 60, 90, and 120 minutes after the first puff | Area under the plasma nicotine concentration-time curve from time 0 to 120 minutes during the defined use session |
| Nicotine Cmax120-180 | 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) | Maximum plasma nicotine concentration during the ad libitum use session, adjusted for baseline nicotine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Puff topography: puff count | Throughout ad libitum use session (60 minutes) | Measured during the ad libitum use session with a CReSS Pocket topography device |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Outcome: heart rate after defined use | At 8 minutes relative to first puff of defined use session | Heart rate after the subject has spent at least 5 minutes in the seated position |
| Safety Outome: diastolic blood pressure after ad libitum use | At 60 minutes relative to first puff of ad libitum use session | Blood pressure measured after the subject has spent at least 5 minutes in the seated position |
| Safety Outome: diastolic blood pressure after defined use | At 8 minutes relative to first puff of defined use session | Blood pressure measured after the subject has spent at least 5 minutes in the seated position |
| Safety Outome: systolic blood pressure after ad libitum use | At 60 minutes relative to first puff of ad libitum use session | Blood pressure measured after the subject has spent at least 5 minutes in the seated position |
| Safety Outome: systolic blood pressure after defined use | At 8 minutes relative to first puff of defined use session | Blood pressure measured after the subject has spent at least 5 minutes in the seated position |
| Safety Outcome: heart rate after ad libitum use | At 60 minutes relative to first puff of ad libitum use session | Heart rate after the subject has spent at least 5 minutes in the seated position |
Countries
United States
Outcome results
None listed