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OpenTrials
Completed

NCT Number: NCT05457634

Nicotine Uptake and Abuse Liability Assessments of Blu Disposable Electronic Cigarettes

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.

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Key information

Conditions

Healthy Volunteers

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LA Clinical Trials, LLC

Burbank, California, 91505, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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 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 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 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 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.

Primary outcomes

  1. Nicotine Cmax0-120

    Time frame: 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

  2. Nicotine Cmax120-180

    Time frame: 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

  3. Nicotine AUC0-120

    Time frame: 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

  4. Nicotine AUC120-180

    Time frame: 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

  5. Urge to Smoke - Defined use

    Time frame: 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.

  6. Urge to Smoke - Ad libitum use

    Time frame: 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.

Secondary outcomes

  1. Puff topography: puff count

    Time frame: Throughout ad libitum use session (60 minutes)

    Measured during the ad libitum use session with a CReSS Pocket topography device

Other outcomes

  1. Safety Outcome: heart rate after defined use

    Time frame: At 8 minutes relative to first puff of defined use session

    Heart rate after the subject has spent at least 5 minutes in the seated position

  2. Safety Outcome: heart rate after ad libitum use

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

    Heart rate after the subject has spent at least 5 minutes in the seated position

  3. Safety Outome: systolic blood pressure after defined use

    Time frame: At 8 minutes relative to first puff of defined use session

    Blood pressure measured after the subject has spent at least 5 minutes in the seated position

  4. Safety Outome: systolic blood pressure after ad libitum use

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

    Blood pressure measured after the subject has spent at least 5 minutes in the seated position

  5. Safety Outome: diastolic blood pressure after defined use

    Time frame: At 8 minutes relative to first puff of defined use session

    Blood pressure measured after the subject has spent at least 5 minutes in the seated position

  6. Safety Outome: diastolic blood pressure after ad libitum use

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

    Blood pressure measured after the subject has spent at least 5 minutes in the seated position

Sponsors and collaborators

Lead sponsor

Fontem US LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 14, 2022
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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