Nicotine Uptake and Abuse Liability Assessments of Blu Disposable Electronic Cigarettes

Fontem US LLC20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

Combustible CigaretteOTHER

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 AOTHER

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 BOTHER

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

LA Clinical Trials, LLC

Burbank, California, United States

Outcomes

Primary Outcomes

Nicotine Cmax0-120

Maximum plasma nicotine concentration, during the defined use session, adjusted for baseline nicotine

Time frame: 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

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)

Nicotine AUC0-120

Area under the plasma nicotine concentration-time curve from time 0 to 120 minutes during the defined use session

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: at 15, 30, 45, and 60 minutes after the start of the ad libitum use session

Data from ClinicalTrials.gov

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Nicotine Uptake and Abuse Liability Assessments of Blu Disposable Electronic Cigarettes

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes