Clinical trial NCT05457634: Nicotine Uptake and Abuse Liability Assessments of 5 Blu Disposable Electronic Cigarettes in Comparison to a Combustible Cigarette
Official title: Nicotine Uptake and Abuse Liability Assessments of 5 Blu Disposable Electronic Cigarettes in Comparison to a Combustible Cigarette
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Fontem Ventures BV
Sponsor class: INDUSTRY
First posted: 2022-07-14
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Nicotine Cmax0-120
timeFrame: 5 minutes before and at 3, 5, 7, 10, 15, 20, 30, 45, 60, 90, and 120 minutes after the first puff
measure: Nicotine Cmax120-180
timeFrame: 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)
measure: Nicotine AUC0-120
timeFrame: 5 minutes before and at 3, 5, 7, 10, 15, 20, 30, 45, 60, 90, and 120 minutes after the first puff
measure: Nicotine AUC120-180
timeFrame: at 15, 30, 45, and 60 minutes after the start of the ad libitum use session
measure: Urge to Smoke - Defined use
timeFrame: 5 minutes before and at 3, 5, 7, 10, 15, 20, 30, 45, 60, 90, and 120 minutes after the first puff
measure: Urge to Smoke - Ad libitum use
timeFrame: at 15, 30, 45, and 60 minutes after the start of the ad libitum use session
Secondary outcomes:
measure: Puff topography: puff count
timeFrame: Throughout ad libitum use session (60 minutes)
Other outcomes:
measure: Safety Outcome: heart rate after defined use
timeFrame: At 8 minutes relative to first puff of defined use session
measure: Safety Outcome: heart rate after ad libitum use
timeFrame: At 60 minutes relative to first puff of ad libitum use session
measure: Safety Outome: systolic blood pressure after defined use
timeFrame: At 8 minutes relative to first puff of defined use session
measure: Safety Outome: systolic blood pressure after ad libitum use
timeFrame: At 60 minutes relative to first puff of ad libitum use session
measure: Safety Outome: diastolic blood pressure after defined use
timeFrame: At 8 minutes relative to first puff of defined use session
measure: Safety Outome: diastolic blood pressure after ad libitum use
timeFrame: At 60 minutes relative to first puff of ad libitum use session
Locations:
city: Burbank
country: United States
facility: LA Clinical Trials, LLC
state: California
Study officials:
References: