Nicotine Uptake and Abuse Liability Assessments of 5 Blu Disposable Electronic Cigarettes in Comparison to a Combustible Cigarette
- Conditions
- Healthy Volunteers
- Interventions
- Other: blu Disposable DOther: blu Disposable BOther: blu Disposable EOther: Combustible CigaretteOther: blu Disposable AOther: blu Disposable C
- Registration Number
- NCT05457634
- Lead Sponsor
- Fontem US LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description blu Disposable Flavor D blu Disposable D - blu Disposable Flavor B blu Disposable B - blu Disposable Flavor E blu Disposable E - Combustible cigarette Combustible Cigarette - blu Disposable Flavor A blu Disposable A - blu Disposable Flavor C blu Disposable C -
- Primary Outcome Measures
Name Time Method 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
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.
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.
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
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
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
- Secondary Outcome Measures
Name Time Method Puff topography: puff count Throughout ad libitum use session (60 minutes) Measured during the ad libitum use session with a CReSS Pocket topography device
Trial Locations
- Locations (1)
LA Clinical Trials, LLC
🇺🇸Burbank, California, United States