Nicotine Uptake and Abuse Liability Assessments of Blu Disposable Electronic Cigarettes

Fontem US

Status: Completed

Conditions: Healthy Volunteers

Treatments: Other: blu Disposable C; Other: blu Disposable E; Other: blu Disposable A; Other: blu Disposable B; Other: blu Disposable D; Other: Combustible Cigarette

Study type: Interventional

Funder types: Industry

Identifiers

NCT05457634

Fontem-PK-01

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 6 patient groups

blu Disposable Flavor A

Experimental group

Description:

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

Treatment:

Other: blu Disposable A

blu Disposable Flavor B

Experimental group

Description:

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

Treatment:

Other: blu Disposable B

blu Disposable Flavor C

Experimental group

Description:

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

Treatment:

Other: blu Disposable C

blu Disposable Flavor D

Experimental group

Description:

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

Treatment:

Other: blu Disposable D

blu Disposable Flavor E

Experimental group

Description:

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

Treatment:

Other: blu Disposable E

Combustible cigarette

Active Comparator group

Description:

Subjects who use their own brand of combustible cigarette

Treatment:

Other: Combustible Cigarette