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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-04

Study Completion Date

2019-04-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparing the Pharmacokinetics of Nicotine Salt Based ENDS in Healthy Smokers

NCT03593239

Nicotine Dependence Nicotine Dependence, Cigarettes Tobacco Use +1 more

COMPLETED NA

United States Pre-Market Tobacco Application Pharmacokinetics

NCT03719391

Nicotine Dependence Nicotine Dependence, Cigarettes Tobacco Use +1 more

COMPLETED NA

Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to JUUL ENDS

NCT04107779

Electronic Cigarette Use Cigarette Use, Electronic Tobacco Use +1 more

COMPLETED NA

Characterize the Nicotine Uptake and Subjective Effects With Use of JUUL Electronic Nicotine Delivery Systems

NCT04123041

Electronic Cigarette Use Tobacco Smoking

COMPLETED NA

Identify Biomarkers of Tobacco Exposure and Nicotine Uptake From JUUL 5% in Adult Smokers

NCT03463837

Nicotine Dependence, Other Tobacco Product Tobacco Use Smoking, Tobacco

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nicotine Dependence Nicotine Dependence, Cigarettes Tobacco Use Tobacco Smoking

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

JUUL Virginia Tobacco flavored 5.0% ENDS

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

Group Type EXPERIMENTAL

JUUL Virginia Tobacco flavored 5.0% ENDS

Intervention Type OTHER

Virginia Tobacco Flavored 5.0% ENDS product is administered using a controlled method and adlibitum

PMI iQOS Heat sticks

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

Group Type EXPERIMENTAL

PMI iQOS Heat sticks

Intervention Type OTHER

PMI IQOS Heat sticks is administered using a controlled method and ad-libitum

Reynolds VUSE Solo ENDS - Original

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

Group Type EXPERIMENTAL

Reynolds VUSE Solo ENDS - Original

Intervention Type OTHER

Reynolds VUSE solo ENDS - Original is administered using a controlled method and ad-libitum

Imperial MyBlu ENDS - Original

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

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

Group Type EXPERIMENTAL

Imperial MyBlu ENDS - Original

Intervention Type OTHER

Imperial MyBlu ENDS- original is administered using a controlled method and ad-libitum

Altria MarkTen ENDS - Bold Classic

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

Group Type EXPERIMENTAL

Altria MarkTen ENDS - Bold Classic

Intervention Type OTHER

Altria MarkTen ENDS - Bold Classic is administered using a controlled method and ad-libitum

MLV PHIX ENDS - Original Tobacco

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

Group Type EXPERIMENTAL

MLV PHIX ENDS - Original Tobacco

Intervention Type OTHER

MLV PHIX ENDS - Original Tobacco is administered using a controlled method and ad-libitum

NJOY Daily EXTRA ENDS - Rich Tobacco

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

Group Type EXPERIMENTAL

NJOY Daily EXTRA ENDS - Rich Tobacco

Intervention Type OTHER

NJOY Daily EXTRA ENDS - Rich Tobacco is administered using a controlled method and ad-libitum

Altria Marlboro combustible cigarette - Red

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

Group Type EXPERIMENTAL

Altria Marlboro combustible cigarette - Red

Intervention Type OTHER

Altria Marlboro combustible cigarette - Red is administered using a controlled method and ad-libitum

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

JUUL Virginia Tobacco flavored 5.0% ENDS

Virginia Tobacco Flavored 5.0% ENDS product is administered using a controlled method and adlibitum

Intervention Type OTHER

PMI iQOS Heat sticks

PMI IQOS Heat sticks is administered using a controlled method and ad-libitum

Intervention Type OTHER

Reynolds VUSE Solo ENDS - Original

Reynolds VUSE solo ENDS - Original is administered using a controlled method and ad-libitum

Intervention Type OTHER

Imperial MyBlu ENDS - Original

Imperial MyBlu ENDS- original is administered using a controlled method and ad-libitum

Intervention Type OTHER

Altria MarkTen ENDS - Bold Classic

Altria MarkTen ENDS - Bold Classic is administered using a controlled method and ad-libitum

Intervention Type OTHER

MLV PHIX ENDS - Original Tobacco

MLV PHIX ENDS - Original Tobacco is administered using a controlled method and ad-libitum

Intervention Type OTHER

NJOY Daily EXTRA ENDS - Rich Tobacco

NJOY Daily EXTRA ENDS - Rich Tobacco is administered using a controlled method and ad-libitum

Intervention Type OTHER

Altria Marlboro combustible cigarette - Red

Altria Marlboro combustible cigarette - Red is administered using a controlled method and ad-libitum

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes