Evaluating Selected Constituents in the Exhaled Breath Samples

NCT04143256 | Completed

• 1 other identifier: PROT-00109
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 3

Brief Summary

An Open-Label, Multi-Center Study to Evaluate Selected Constituents in the Exhaled Breath Samples From the Use of JUUL Nicotine Salt Pod System Product (5% and 3% Virginia Tobacco, Mint, Mango, Menthol) Users and Conventional Cigarettes (Non-Menthol and Menthol Flavors)

Conditions

Electronic Cigarette Use; Cigarette Use, Electronic; Tobacco Use; Tobacco Smoking

Keywords

Electronic Nicotine Delivery; Combustible Cigarettes; Nicotine; Exhaled Breath

Outcome Measures

Primary Outcomes (9)

• Evaluate Absolute Change from Baseline Level

  The absolute change from baseline level of nicotine for each subject.

  Up to 6-hours

• Evaluate Absolute Change from Baseline Level

  The absolute change from baseline level of propylene glycol for each subject.

  Up to 6-hours

• Evaluate Absolute Change from Baseline Level

  The absolute change from baseline level of vegetable glycerin for each subject.

  Up to 6-hours

• Evaluate Absolute Change from Baseline Level

  The absolute change from baseline level of acetaldehyde for each subject.

  Up to 6-hours

• Evaluate Absolute Change from Baseline Level

  The absolute change from baseline level of acrolein for each subject.

  Up to 6-hours

• Evaluate Absolute Change from Baseline Level

  The absolute change from baseline level of benzoic acid for each subject.

  Up to 6-hours

• Evaluate Absolute Change from Baseline Level

  The absolute change from baseline level of formaldehyde for each subject.

  Up to 6-hours

• Evaluate Absolute Change from Baseline Level

  The absolute change from baseline level of menthol for each subject.

  Up to 6-hours

• Evaluate Absolute Change from Baseline Level

  The absolute change from baseline level of carbon monoxide for each subject.

  Up to 6-hours

Secondary Outcomes (10)

• Compare the change between baseline and post-baseline levels

  Up to 6-hours

• Compare the change between baseline and post-baseline levels

  Up to 6-hours

• Compare the change between baseline and post-baseline levels

  Up to 6-hours

• Compare the change between baseline and post-baseline levels

  Up to 6-hours

• Compare the change between baseline and post-baseline levels

  Up to 6-hours

Study Arms (6)

Group I

EXPERIMENTAL

Subjects with ENDS user history may be randomized to use JUUL ENDS 5% Virginia Tobacco and 3% Virginia Tobacco

Other: JUUL ENDS 5% Virginia Tobacco; Other: JUUL 3% Virginia Tobacco ENDS

Group II

EXPERIMENTAL

Subjects with ENDS user history may be randomized to use JUUL ENDS 5% Mint and 3% Mint

Other: JUUL 5% Mint ENDS; Other: JUUL 3% Mint ENDS

Group III

EXPERIMENTAL

Subjects with ENDS user history may be randomized to use JUUL ENDS 5% Menthol and 3% Menthol

Other: JUUL 5% Menthol ENDS; Other: JUUL 3% Menthol ENDS

Group IV

EXPERIMENTAL

Subjects with ENDS user history may be randomized to use JUUL ENDS 5% Mango and 3% Mango

Other: JUUL 5% Mango ENDS; Other: JUUL 3% Mango ENDS

Group V

EXPERIMENTAL

Subjects with cigarette user history will be assigned to use US Cigarette, Non-Menthol Flavor (Marlboro Gold King Size)

Other: US Cigarette, Non-menthol - Marlboro Gold King Size

Group VI

EXPERIMENTAL

Subjects with cigarette user history will be assigned to use US Cigarette, Menthol Flavor (Newport King Size)

Other: US Cigarette, Menthol - Newport King Size

Interventions

JUUL ENDS 5% Virginia Tobacco OTHER

JUUL ENDS Virginia Tobacco 5% nicotine strength

Group I

JUUL 3% Virginia Tobacco ENDS OTHER

JUUL ENDS Virginia Tobacco 3% nicotine strength

Group I

JUUL 5% Mint ENDS OTHER

JUUL ENDS Mint 5% nicotine strength

Group II

JUUL 3% Mint ENDS OTHER

JUUL ENDS Mint 3% nicotine strength

Group II

JUUL 5% Menthol ENDS OTHER

JUUL ENDS Menthol 5% nicotine strength

Group III

JUUL 3% Menthol ENDS OTHER

JUUL ENDS Menthol 3% nicotine strength

Group III

JUUL 5% Mango ENDS OTHER

JUUL ENDS Mango 5% nicotine strength

Group IV

JUUL 3% Mango ENDS OTHER

JUUL ENDS Mango 3% nicotine strength

Group IV

US Cigarette, Non-menthol - Marlboro Gold King Size OTHER

US Cigarette, Non-menthol - Marlboro Gold King Size

Group V

US Cigarette, Menthol - Newport King Size OTHER

US Cigarette, Menthol - Newport King Size

Group VI

Eligibility Criteria

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

You may qualify if:

• Be a healthy male or female aged 21 - 65 years, inclusive, at the time of signing the informed consent.
• Be informed of the nature of the study, agree to and are able to read, review, and sign the informed consent document prior to any study procedures. The informed consent document will only be available in English. Therefore, the volunteer must have the ability to read and communicate in English in order to participate in the study.
• Complete the screening process up to 28 days prior to Day 1.
• Satisfy the user definitions of either cigarette user or ENDS/closed system user.
• Agree to abide by the study restrictions.
• Agree to abstain from use of alcohol 12 hours before the start of Day 1 for Groups I through VI.
• Agree to abstain from use of any nicotine products 12 hours before the start of study day 1 for Groups I through VI.
• Agree to not consume any mint or menthol flavor products (e.g., chewing gum, mouth wash, toothpaste, etc.) 12 hours before the start of testing for Groups I through VI.
• Have a positive urine cotinine result at screening of \>200 ng/ml.
• A female subject of childbearing potential must have been using one (1) of the following forms of contraception and agree to continue using it through completion of the trial:
• hormonal (e.g., oral, vaginal ring, transdermal patch, implant, or injection) consistently for at least 3 months prior to Day 1;
• double barrier method (e.g., condom with spermicide, diaphragm with spermicide) at screening.
• intrauterine device for at least 3 months prior to Day 1;
• a partner who has been vasectomized for at least 6 months prior to Day 1;
• abstinence beginning at least 6 months prior to screening.

You may not qualify if:

• Report receiving any investigational product, participated in any previous clinical study for an investigational drug, device, biologic, or tobacco product within 30 days prior to screening.
• Report at screening using both ENDS and conventional cigarettes (menthol or non-menthol) (dual users), or use of other inhaled products (such as, but not limited to cannabis) in the past 3 months.
• For ENDS users, be unable to perform CPS or incapable of drawing down the pod weight by 20-60mg after 3 attempts at screening.
• If female, be pregnant, have a positive urine pregnancy test at screening, be lactating, breast feeding, or intend to become pregnant during the time period from screening through the end of the study.
• Have any clinically significant results from physical examinations and vital signs assessments, as judged by the Investigator.
• Have a systolic blood pressure \< 90 mmHg or \> 150 mmHg, diastolic blood pressure \< 40 mmHg or \> 95 mmHg, or heart rate \< 40 bpm or \> 99 bpm at screening.
• Report a clinically significant illness during the 30 days prior to enrollment, as determined by the Investigator.
• Report a history of drug or alcohol addiction or abuse within the past 1 year.
• Have a positive screen for alcohol or drugs of abuse at screening or at check-in on Day 1.
• Have a body mass index (BMI) greater than 40 kg/m2 or less than 18 kg/m2 at screening.
• Have used prescription anti-diabetic medication and/or insulin therapy within 12 months of screening.
• Have taken medication for depression, asthma, or chronic obstructive pulmonary disease within 6 months of screening.
• Have used prescription or over-the-counter bronchodilator medication (e.g., inhaled or oral β-agonists) within 6 months of screening.
• Be breast-feeding or pregnant female subjects (confirmed by a positive pregnancy test). Female subjects, who are considered women of child bearing potential (WOCBP) and sexually active, must be willing and able to use an acceptable method of contraception from screening through the end of the study.
• Have experienced an allergic reaction following previous e-cigarette use or with exposure to any primary components of the e-liquids (nicotine, flavor, benzoic acid, propylene glycol, and/or glycerol.

Sponsors & Collaborators

• Juul Labs, Inc.: lead

Study Sites (3)

Frontage Clinical Services

Secaucus, New Jersey, 07094, United States

Location

Rose Research Center

Charlotte, North Carolina, 28262, United States

Location

Rose Research Center

Raleigh, North Carolina, 27617, United States

Location

Related Publications (1)

• Oldham MJ, Bailey PC, Castro N, Lang Q, Salehi A, Rostami AA. Prediction of potential passive exposure from commercial electronic nicotine delivery systems using exhaled breath analysis and computational fluid dynamic techniques. J Breath Res. 2021 Oct 5;15(4). doi: 10.1088/1752-7163/ac2884.

  PMID: 34544050 DERIVED

MeSH Terms

Conditions

Vaping; Tobacco Use; Tobacco Smoking

Condition Hierarchy (Ancestors)

Smoking; Behavior

Study Design

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

Model Details: Four crossover groups and two single arm groups

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 29, 2019
• Study Start: October 3, 2019
• Primary Completion: December 12, 2019
• Study Completion: December 13, 2019
• Last Updated: February 11, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)