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

Sponsor
Fontem US LLC (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05457634
Collaborator
(none)
20
1
6
16.6
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Combustible Cigarette
  • Other: blu Disposable A
  • Other: blu Disposable B
  • Other: blu Disposable C
  • Other: blu Disposable D
  • Other: blu Disposable E
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Nicotine Uptake and Abuse Liability Assessments of 5 Blu Disposable Electronic Cigarettes in Comparison to a Combustible Cigarette
Actual Study Start Date :
Jul 13, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: blu Disposable 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

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

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

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

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

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.

Outcome Measures

Primary Outcome Measures

  1. Nicotine Cmax0-120 [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 [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 [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 [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 [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 [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 Outcome Measures

  1. Puff topography: puff count [Throughout ad libitum use session (60 minutes)]

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

Other Outcome Measures

  1. Safety Outcome: heart rate after defined use [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 [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 LA Clinical Trials, LLC Burbank California United States 91505

Sponsors and Collaborators

  • Fontem US LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fontem US LLC
ClinicalTrials.gov Identifier:
NCT05457634
Other Study ID Numbers:
  • Fontem-PK-01
First Posted:
Jul 14, 2022
Last Update Posted:
Jul 14, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 14, 2022