Nicotine Uptake and Abuse Liability Assessments of Blu Disposable Electronic Cigarettes

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: blu Disposable A; Other: blu Disposable B; Other: blu Disposable C; Other: blu Disposable D; Other: blu Disposable E; Other: Combustible Cigarette

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Burbank, California, United States, 91505
      • LA Clinical Trials, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: blu Disposable Flavor A; Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor A	Other: 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.
Experimental: blu Disposable Flavor B; Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor B	Other: 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.
Experimental: blu Disposable Flavor C; Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor C	Other: 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.
Experimental: blu Disposable Flavor D; Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor D	Other: 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.
Experimental: blu Disposable Flavor E; Subjects who use the blu disposable electronic cigarette 2.4% nicotine with Flavor E	Other: 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.
Active Comparator: Combustible cigarette; Subjects who use their own brand of combustible cigarette	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Puff topography: puff count	Measured during the ad libitum use session with a CReSS Pocket topography device	Throughout ad libitum use session (60 minutes)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Fontem US LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2021
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Fontem-PK-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No