Nicotine Uptake and Abuse Liability Assessments of Blu Disposable Electronic Cigarettes

NCT05457634 | Completed

• 1 other identifier: Fontem-PK-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Puff topography: puff count

  Throughout ad libitum use session (60 minutes)

Other Outcomes (6)

• Safety Outcome: heart rate after defined use

  At 8 minutes relative to first puff of defined use session

• Safety Outcome: heart rate after ad libitum use

  At 60 minutes relative to first puff of ad libitum use session

• Safety Outome: systolic blood pressure after defined use

  At 8 minutes relative to first puff of defined use session

Study Arms (6)

blu Disposable Flavor A

EXPERIMENTAL

Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor A

Other: blu Disposable A

blu Disposable Flavor B

EXPERIMENTAL

Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor B

Other: blu Disposable B

blu Disposable Flavor C

EXPERIMENTAL

Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor C

Other: blu Disposable C

blu Disposable Flavor D

EXPERIMENTAL

Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor D

Other: blu Disposable D

blu Disposable Flavor E

EXPERIMENTAL

Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor E

Other: blu Disposable E

Combustible cigarette

ACTIVE COMPARATOR

Subjects who use their own brand of combustible cigarette

Other: Combustible Cigarette

Interventions

Combustible Cigarette OTHER

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.

Combustible cigarette

blu Disposable A OTHER

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 Flavor A

blu Disposable B OTHER

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 Flavor B

blu Disposable C OTHER

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 Flavor C

blu Disposable D OTHER

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 Flavor D

blu Disposable E OTHER

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.

blu Disposable Flavor E

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fontem US LLC: lead

Study Sites (1)

LA Clinical Trials, LLC

Burbank, California, 91505, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: July 13, 2021
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

US (1)