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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05457634
• Other study ID #: Fontem-PK-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 13, 2021
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Fontem Ventures BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Combustible Cigarette
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.
• blu 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.
• blu 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.
• blu 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.
• blu 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.
• blu 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.

Locations

Country	Name	City	State
United States	LA Clinical Trials, LLC	Burbank	California

Sponsors (1)

Lead Sponsor	Collaborator
Fontem US LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Safety Outcome: heart rate after ad libitum use	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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	Puff topography: puff count	Measured during the ad libitum use session with a CReSS Pocket topography device	Throughout ad libitum use session (60 minutes)