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

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ClinicalTrials.gov Identifier: NCT03596034
Recruitment Status : Completed
First Posted : July 23, 2018
Last Update Posted : June 14, 2021
Sponsor:
Collaborator:
Rose Research Center, LLC
Information provided by (Responsible Party):
Juul Labs, Inc.

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

Condition or disease Intervention/treatment Phase
Tobacco Use Nicotine Dependence, Other Tobacco Product Tobacco Smoking Other: JUUL 5%, Virginia Tobacco, ENDS product Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Study to Characterize Puff Topography With Use of a JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers
Actual Study Start Date : August 9, 2018
Actual Primary Completion Date : September 26, 2018
Actual Study Completion Date : September 26, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Experimental: 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.
Other: 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.
Other Name: ENDS




Primary Outcome Measures :
  1. Puff Topography Parameter - Puff Duration [ Time Frame: 15 days ]
    To characterize overall puff duration

  2. Puff Topography Parameter - Puff Volume [ Time Frame: 15 days ]
    To characterize overall puff volume

  3. Puff Topography Parameter - Peak Puff Flow Rate [ Time Frame: 15 days ]
    To characterize overall peak puff flow rate

  4. Puff Topography Parameter - Average Puff Flow Rate [ Time Frame: 15 days ]
    To characterize overall average puff flow

  5. Puff Topography Parameter - Inter-Puff Interval [ Time Frame: 15 days ]
    To characterize overall inter-puff interval (time between puffs)


Secondary Outcome Measures :
  1. Self-reported product use over 15-day period [ Time Frame: 15 days ]
    To assess the relationship between puff topography parameters and self-reported product use (number of puffs per day and number of JUULpods started each day) in a 15-day product use period.

  2. Subjective measure of product liking [ Time Frame: 15 days ]
    To assess the relationship between puff topography parameters and JUUL 5% ENDs liking using a "Product Liking Questionnaire". Visual analogue scale with scale 0 (Not at all) to 100 (Extremely) in response to question "I like using the JUUL Product."

  3. Subjective measure of cigarette dependence [ Time Frame: 15 days ]
    Assessment of cigarette dependence with "Fagerstrom Test for Cigarette Dependence Questionnaire (FTCD)". Questionnaire consists of 6 questions.

  4. Subjective measure of smoking urges [ Time Frame: 15 days ]
    Assessment of current smoking urge with "Questionnaire of Smoking Urges - Brief (QAU-B)". Responses to various statements with scale 1 (Strongly Disagree) to 7 (Strongly Agree).

  5. Subjective measure of effects of nicotine [ Time Frame: 15 days ]
    Assessment of nicotine using the "Direct Effects of Nicotine Scale." Visual analogue scale with scale 0 (Not at All) to 100 (Extremely) in response to words describing how the subject feels.

  6. Subject measure of affect [ Time Frame: 15 days ]
    Assessment of affect using the "Positive and Negative Affect Scale (PANAS)". Scale consists of a number of words that describe different feelings and emotions. Scale 1 (Very Slightly or Not at All), 2 (A Little), 3 (Moderately), 4 (Quite a Bit), 5 (Extremely).

  7. Subjective measure of nicotine withdrawal [ Time Frame: 15 days ]
    Assessment of nicotine withdrawal using the "Nicotine Withdrawal Scale (MNWS-R)." Scale consists of 15 words/statements that describe different feelings. Scale 0 (None) to 4 (Severe).



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key 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.

Key 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596034


Locations
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United States, North Carolina
Rose Research Center Charlotte
Charlotte, North Carolina, United States, 28262
Rose Research Center Raleigh
Raleigh, North Carolina, United States, 27617
Sponsors and Collaborators
Juul Labs, Inc.
Rose Research Center, LLC
Investigators
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Principal Investigator: Jed Rose, MD Rose Research Center, LLC
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Responsible Party: Juul Labs, Inc.
ClinicalTrials.gov Identifier: NCT03596034    
Other Study ID Numbers: Protocol No.755-00042
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: June 14, 2021
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Juul Labs, Inc.:
Electronic Nicotine Delivery System (ENDS)
ENDS
Puff Topography
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders