Clinical Study Comparing 7 ENDS Products and 1 Combustible Cigarette Using 2 Delivery Methods.

Juul Labs

Status: Completed

Conditions: Nicotine Dependence; Tobacco Smoking; Nicotine Dependence, Cigarettes; Tobacco Use

Treatments: Other: Imperial MyBlu ENDS - Original; Other: JUUL Virginia Tobacco flavored 5.0% ENDS; Other: NJOY Daily EXTRA ENDS - Rich Tobacco; Other: MLV PHIX ENDS - Original Tobacco; Other: Reynolds VUSE Solo ENDS - Original; Other: Altria Marlboro combustible cigarette - Red; Other: Altria MarkTen ENDS - Bold Classic; Other: PMI iQOS Heat sticks

Study type: Interventional

Funder types: Industry

Identifiers

NCT03700112

PROT-00013

Details and patient eligibility

About

A Randomized Study Comparing Nicotine Pharmacokinetics of Seven Electronic Cigarette Products and One Traditional Cigarette Across Two Delivery (10 puff and ad- libitum) Conditions, in Healthy Adult Smokers

Full description

E- cigarettes may be an acceptable alternative to traditional cigarette smoking. By utilizing vaporization rather than combustion, the generation and inhalation of HPHCs, smoke, and carbon monoxide (CO) may be reduced or avoided. This study will provide an understanding of the in vitro levels of nicotine obtained with use of the company's ENDS products compared to competitor products marketed in the United States of America (USA), and to a popular brand of combustible cigarette smoked in the USA.

Enrollment: 25 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or female aged 18 to 60 years of age inclusive.
2. BMI between 18 to 35 kg / m2 inclusive.
3. Healthy based on medical history and screening assessments, in the opinion of the Investigator.
4. Current smoker of at least 8 cigarettes per day on average.
5. Has been smoking for at least 12 months prior to screening. Brief periods of non-smoking (e.g., up to ~7 consecutive days due to illness, trying to quit, participation in a study where smoking was prohibited) are permitted at the discretion of the Investigator.
6. Able to participate, and willing to give written informed consent and comply with study restrictions.

Exclusion criteria

1. Clinically relevant medical or psychiatric disorder, in the opinion of the Investigator.
2. Clinically significant abnormality on screening ECG.
3. Sustained blood pressure recordings at screening of < 90 mmHg or > 150 mmHg for systolic blood pressure, or < 50 mmHg or > 90 mmHg for diastolic blood pressure.
4. Sustained resting heart rate of > 100 or < 40 beats per minute at screening.
5. Positive result for urine drugs of abuse test or alcohol breath test at screening. If a positive urine drug test is observed, and it is believed the positive urine test is due to prescription drugs, the PI should obtain documentation that a) confirms the subject's use of the prescribed medication, and b) the prescribed medication will cause a false positive drug test.
6. Clinically significant abnormality in laboratory test results at screening, in the opinion of the Investigator.
7. Exposure to an investigational drug in a clinical trial within 1 month prior toAssessment Day 1.
8. Blood or plasma donation of > 500 mL within 1 month prior to Assessment Day 1.
9. Positive urine pregnancy test at screening or Assessment Day 1 in female subject.
10. Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 8 patient groups

JUUL Virginia Tobacco flavored 5.0% ENDS

Experimental group

Description:

Administration of JUUL Virginia Tobacco flavored 5.0% ENDS product consumed using 10 puffs delivery method Administration of JUUL Virginia Tobacco flavored 5.0% ENDS product consumed Ad-libitum delivery method

Treatment:

Other: JUUL Virginia Tobacco flavored 5.0% ENDS

PMI iQOS Heat sticks

Experimental group

Description:

Administration of PMI iQOS Heat sticks - Regular consumed using 10 puffs delivery method Administration of PMI iQOS Heat sticks - Regular consumed ad-libitum delivery method

Treatment:

Other: PMI iQOS Heat sticks

Reynolds VUSE Solo ENDS - Original

Experimental group

Description:

Administration of Reynolds VUSE Solo ENDS - Original consumed using 10 puffs delivery method Administration of Reynolds VUSE Solo ENDS - Original consumed using ad-libitum delivery method

Treatment:

Other: Reynolds VUSE Solo ENDS - Original

Imperial MyBlu ENDS - Original

Experimental group

Description:

Administration of Imperial MyBlu ENDS - Original consumed using 10 puffs delivery method Administration of Imperial MyBlu ENDS - Original consumed using ad-libitum delivery method

Treatment:

Other: Imperial MyBlu ENDS - Original

Altria MarkTen ENDS - Bold Classic

Experimental group

Description:

Administration of Altria MarkTen ENDS - Bold Classic consuming using 10 puffs delivery method Administration of Altria MarkTen ENDS - Bold Classic consuming using ad-libitum delivery method

Treatment:

Other: Altria MarkTen ENDS - Bold Classic

MLV PHIX ENDS - Original Tobacco

Experimental group

Description:

Administration of MLV PHIX ENDS - Original Tobacco consumed using 10 puffs delivery method Administration of with MLV PHIX ENDS - Original Tobacco consumed using ad-libitum delivery method

Treatment:

Other: MLV PHIX ENDS - Original Tobacco

NJOY Daily EXTRA ENDS - Rich Tobacco

Experimental group

Description:

Administration of NJOY Daily EXTRA ENDS - Rich Tobacco consumed using 10 puffs delivery method Administration of NJOY Daily EXTRA ENDS - Rich Tobacco consumed using delivery method and ad-libitum

Treatment:

Other: NJOY Daily EXTRA ENDS - Rich Tobacco

Altria Marlboro combustible cigarette - Red

Experimental group

Description:

Administration of Altria Marlboro combustible cigarette - Red consumed using 10 puffs delivery method Administration of Altria Marlboro combustible cigarette - Red consumed using ad-libitum delivery method

Treatment:

Other: Altria Marlboro combustible cigarette - Red