CompletedNot Applicable

Assess Biomarkers of Tobacco Exposure and Nicotine Pharmacokinetics in Smokers After a 5-Day In-Clinic Confinement Switch to an Electronic Cigarette or Nicotine Gum

United States153 participantsStarted 2014-12

Plain-language summary

A single-center, randomized, controlled, switching, open-label, parallel cohort study. Smoking subjects will be confined to a clinic for 9 days. During their stay, baseline assessments during ad libitum smoking will occur for the first 3 days. Following baseline, subjects will be switched to either an Electronic Cigarette or Nicotine Gum, and post-product switch assessments will occur for 6 days.

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 (ICF) and complete questionnaires written in English;
✓. Generally healthy males or females, 21 to 60 years of age (inclusive);
✓. Screening expired-air carbon monoxide (ECO) level ≥ 15 parts per million (ppm; sample taken 30 to 60 minutes after smoking a single UB cigarette);
✓. Currently smokes combustible, filtered, nonmenthol or menthol cigarettes, 83 mm to 100 mm length;
✓. Self-reports that cigarettes are the only tobacco or nicotine-containing product used within 30 days of the Screening Visit;
✓. Self-reports at the Screening Visit smoking at least 10 cigarettes per day and inhaling the smoke for at least 6 months prior to the Screening Visit;
✓. Response to Fagerström Test for Nicotine Dependence (FTND) Question 1 ("How soon after you wake up do you smoke your first cigarette?") is either "Within 5 minutes" or "6-30 minutes" at the Screening Visit;
✓. Positive urine cotinine test at Screening and Enrollment;

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 (eg, hypertension, asthma, or other lung disease, cardiac disease, neurological disease, or psychiatric disorders) based on screening assessments such as safety labs, medical history, and physical/oral examinations;

What they're measuring

Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

Timeframe: 6 days

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, 3, 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, 3, 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, 3, 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)

Timeframe: Three times during baseline UB cigarette smoking and 3 times per day for 5 days after switch to randomized IP use

Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

Timeframe: 6 days

Trial details

NCT IDNCT02323438

SponsorR.J. Reynolds Vapor Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-05

View on ClinicalTrials.gov More Smoking trials

Plain-language summary

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 (ICF) and complete questionnaires written in English;
✓. Generally healthy males or females, 21 to 60 years of age (inclusive);
✓. Screening expired-air carbon monoxide (ECO) level ≥ 15 parts per million (ppm; sample taken 30 to 60 minutes after smoking a single UB cigarette);
✓. Currently smokes combustible, filtered, nonmenthol or menthol cigarettes, 83 mm to 100 mm length;
✓. Self-reports that cigarettes are the only tobacco or nicotine-containing product used within 30 days of the Screening Visit;
✓. Self-reports at the Screening Visit smoking at least 10 cigarettes per day and inhaling the smoke for at least 6 months prior to the Screening Visit;
✓. Response to Fagerström Test for Nicotine Dependence (FTND) Question 1 ("How soon after you wake up do you smoke your first cigarette?") is either "Within 5 minutes" or "6-30 minutes" at the Screening Visit;
✓. Positive urine cotinine test at Screening and Enrollment;

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 (eg, hypertension, asthma, or other lung disease, cardiac disease, neurological disease, or psychiatric disorders) based on screening assessments such as safety labs, medical history, and physical/oral examinations;

What they're measuring

Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

Timeframe: 6 days

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, 3, 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, 3, 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, 3, 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)

Timeframe: Three times during baseline UB cigarette smoking and 3 times per day for 5 days after switch to randomized IP use

Changes in biomarkers of tobacco exposure after a 5-day, in-clinic switch from usual brand (UB) cigarettes to an Electronic Cigarette or Nicotine Gum

Timeframe: 6 days