A Study to Characterize Puff Topography With Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-09

Study Completion Date

2018-09-26

Brief Summary

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A Study to Characterize Puff Topography with Use of a JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers

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Detailed Description

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This will be an open label study to evaluate puff topography in adult smokers using a JUUL 5% ENDS. Up to 30 subjects will be enrolled and evaluated on Day 1 and Day 15. The duration of the study is 15 days with up to a 28 days screening window.

Conditions

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Tobacco Use Nicotine Dependence, Other Tobacco Product Tobacco Smoking

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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JUUL 5%, Virginia Tobacco, ENDS product

Subjects participate in a 15 day product use period during which subjects will be requested to predominantly use the JUUL 5% product ad libitum as their primary source of nicotine. Subjects will be asked to report their daily use of the JUUL 5% product and combustibles per day (CPD) throughout the 15 day product use period.

Group Type EXPERIMENTAL

JUUL 5%, Virginia Tobacco, ENDS product

Intervention Type OTHER

Subjects participate in a 15 day product use period during which subjects will be requested to predominantly use the JUUL 5% product ad libitum as their primary source of nicotine. Subjects will be asked to report their daily use of the JUUL 5% product and CPD throughout the 15 day product use period.

Interventions

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JUUL 5%, Virginia Tobacco, ENDS product

Subjects participate in a 15 day product use period during which subjects will be requested to predominantly use the JUUL 5% product ad libitum as their primary source of nicotine. Subjects will be asked to report their daily use of the JUUL 5% product and CPD throughout the 15 day product use period.

Intervention Type OTHER

Other Intervention Names

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ENDS

Eligibility Criteria

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Inclusion Criteria

1. Healthy, adult, male or female smoker, 21 to 65 years of age
2. Has been a smoker for at least 12 months prior to Screening.
3. Currently smokes an average of 5 to 40 manufactured combustible (menthol or non menthol) cigarettes per day.
4. A female subject of childbearing potential must have been using 1 of the following forms of contraception and agree to continue using it through completion of the study
5. Provides voluntary consent to participate in this study documented on the signed informed consent form.

Exclusion Criteria

1. Has a clinically significant abnormal finding on the physical examination, medical history, vital signs, ECG, or clinical laboratory results, in the opinion of the PI.
2. Has a body mass index (BMI) \> 40 kg/m2 or \< 18 kg/m2 at Screening.
3. Has a history of drug or alcohol abuse within 24 months of Day 1.
4. If female, the subject is pregnant, lactating, or intends to become pregnant during the time period from Screening through the end of study.

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes