CompletedNot Applicable

Comparison of Nicotine Plasma Concentrations and Subjective Effects for Three Menthol Electronic Cigarettes vs Combustible Menthol Cigarettes and Nicotine Gum

United States71 participantsStarted 2016-01

Plain-language summary

The purpose of this study is to measure plasma nicotine uptake parameters, physiological measures, and subjective effect measures in smokers during and following a single ad libitum use of three menthol electronic cigarettes versus combustible menthol cigarettes and nicotine gum.

Who can participate

Age range21 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Able to read, understand, and willing to sign an informed consent form and complete questionnaires written in English.
✓. Generally healthy male or female, 21 to 60 years of age, inclusive, at Screening.
✓. Expired breath carbon monoxide (ECO) level is ≥ 15 ppm and ≤ 100 ppm at the Screening and Randomization Visits, measured between 12 p.m. and 6 p.m.
✓. Combustible menthol cigarettes are the only tobacco product used within (≤) 30 days of Screening.
✓. Smokes combustible, filtered, menthol cigarettes, 83 mm to 100 mm in length.
✓. Agrees to smoke usual brand (UB) menthol cigarette throughout the study period. Usual brand cigarette is defined as the menthol cigarette brand style currently smoked most frequently by the subject.
✓. Smokes at least 10 menthol cigarettes per day (on average) and inhales the smoke, for at least 6 months prior to Screening. Brief periods of abstinence due to illness, quit attempt (prior to 30 days of Screening), or clinical study participation (prior to 30 days of Screening) will be allowed at the discretion of the Investigator.
✓. Response at Screening to Fagerstrom Test for Nicotine Dependence, Question 1 ("How soon after you wake up do you smoke your first cigarette?") is either "Within 5 minutes" or "6 - 30 minutes."

Exclusion criteria

✕. Clinically significant or unstable/uncontrolled acute or chronic medical conditions at Screening, as determined by the Investigator, that would preclude a subject from participating safely in the study (e.g., uncontrolled hypertension, asthma or other lung disease, cardiac disease, neurological disease or psychiatric disorders) based on safety assessments such as clinical laboratory tests, medical history, and physical/oral examinations.

What they're measuring

Nicotine pharmacokinetics with respect to initiation of in-clinic investigational product (IP) use following a 12-hour tobacco and nicotine abstinence

Timeframe: -5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes

Nicotine pharmacokinetics with respect to initiation of in-clinic investigational product (IP) use following a 12-hour tobacco and nicotine abstinence

Timeframe: -5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes

Nicotine pharmacokinetics with respect to initiation of in-clinic investigational product (IP) use following a 12-hour tobacco and nicotine abstinence

Timeframe: -5, -0.5, 5, 7.5, 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360 minutes

Subjective effects scores for Urge to Smoke (UTS) with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence

Timeframe: -10, 5, 15, 30, 45, 60, 90, 120, 150, 180, 240, 300, 360 minutes

Subjective effects scores for Intent to Use Again (IUA) with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence

Timeframe: 15, 30, 45, 60, 120, 180, 240, 300, 360 minutes

Subjective effects scores for Product Ratings (PR) with respect to initiation of in-clinic IP use following a 12-hour tobacco and nicotine abstinence

Trial details

NCT IDNCT02664012

SponsorR.J. Reynolds Vapor Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-05

View on ClinicalTrials.gov More Smoking trials

Who can participate

Age range21 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Able to read, understand, and willing to sign an informed consent form and complete questionnaires written in English.
✓. Generally healthy male or female, 21 to 60 years of age, inclusive, at Screening.
✓. Expired breath carbon monoxide (ECO) level is ≥ 15 ppm and ≤ 100 ppm at the Screening and Randomization Visits, measured between 12 p.m. and 6 p.m.
✓. Combustible menthol cigarettes are the only tobacco product used within (≤) 30 days of Screening.
✓. Smokes combustible, filtered, menthol cigarettes, 83 mm to 100 mm in length.
✓. Agrees to smoke usual brand (UB) menthol cigarette throughout the study period. Usual brand cigarette is defined as the menthol cigarette brand style currently smoked most frequently by the subject.
✓. Smokes at least 10 menthol cigarettes per day (on average) and inhales the smoke, for at least 6 months prior to Screening. Brief periods of abstinence due to illness, quit attempt (prior to 30 days of Screening), or clinical study participation (prior to 30 days of Screening) will be allowed at the discretion of the Investigator.
✓. Response at Screening to Fagerstrom Test for Nicotine Dependence, Question 1 ("How soon after you wake up do you smoke your first cigarette?") is either "Within 5 minutes" or "6 - 30 minutes."

Exclusion criteria

✕. Clinically significant or unstable/uncontrolled acute or chronic medical conditions at Screening, as determined by the Investigator, that would preclude a subject from participating safely in the study (e.g., uncontrolled hypertension, asthma or other lung disease, cardiac disease, neurological disease or psychiatric disorders) based on safety assessments such as clinical laboratory tests, medical history, and physical/oral examinations.