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

NCT03596034 | Completed

• 1 other identifier: Protocol No.755-00042
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Tobacco Use; Nicotine Dependence, Other Tobacco Product; Tobacco Smoking

Keywords

Electronic Nicotine Delivery System (ENDS); ENDS; Puff Topography

Outcome Measures

Primary Outcomes (5)

• Puff Topography Parameter - Puff Duration

  To characterize overall puff duration

  15 days

• Puff Topography Parameter - Puff Volume

  To characterize overall puff volume

  15 days

• Puff Topography Parameter - Peak Puff Flow Rate

  To characterize overall peak puff flow rate

  15 days

• Puff Topography Parameter - Average Puff Flow Rate

  To characterize overall average puff flow

  15 days

• Puff Topography Parameter - Inter-Puff Interval

  To characterize overall inter-puff interval (time between puffs)

  15 days

Secondary Outcomes (7)

• Self-reported product use over 15-day period

  15 days

• Subjective measure of product liking

  15 days

• Subjective measure of cigarette dependence

  15 days

• Subjective measure of smoking urges

  15 days

• Subjective measure of effects of nicotine

  15 days

Study Arms (1)

JUUL 5%, Virginia Tobacco, ENDS product

EXPERIMENTAL

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

Interventions

JUUL 5%, Virginia Tobacco, ENDS product 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.

Also known as: ENDS

JUUL 5%, Virginia Tobacco, ENDS product

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, adult, male or female smoker, 21 to 65 years of age
• Has been a smoker for at least 12 months prior to Screening.
• Currently smokes an average of 5 to 40 manufactured combustible (menthol or non menthol) cigarettes per day.
• 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
• Provides voluntary consent to participate in this study documented on the signed informed consent form.

You may not qualify if:

• 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.
• Has a body mass index (BMI) \> 40 kg/m2 or \< 18 kg/m2 at Screening.
• Has a history of drug or alcohol abuse within 24 months of Day 1.
• If female, the subject is pregnant, lactating, or intends to become pregnant during the time period from Screening through the end of study.

Sponsors & Collaborators

• Juul Labs, Inc.: lead
• Rose Research Center, LLC: collaborator

Study Sites (2)

Rose Research Center Charlotte

Charlotte, North Carolina, 28262, United States

Location

Rose Research Center Raleigh

Raleigh, North Carolina, 27617, United States

Location

MeSH Terms

Conditions

Tobacco Use; Tobacco Use Disorder; Tobacco Smoking; Vaping

Condition Hierarchy (Ancestors)

Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Smoking

Study Officials

• Jed Rose, MD

  Rose Research Center, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: July 23, 2018
• Study Start: August 9, 2018
• Primary Completion: September 26, 2018
• Study Completion: September 26, 2018
• Last Updated: June 14, 2021

Record last verified: 2018-10

Locations

US (2)