CompletedNot Applicable

Characterization of Biomarkers of Tobacco Exposure, Urge-to-Smoke Following Exclusive and Dual Ad Lib Use of Electronic Cigarettes

United States105 participantsStarted 2014-09

Plain-language summary

This is a randomized, open-label, forced-switch, parallel, proof-of-concept study to assess exposure to biomarkers of tobacco exposure following short-term ad lib use of three blu e-cigarette products. The primary objectives of this study are to: 1. Compare changes in selected urine and blood biomarkers of tobacco exposure within cohorts following a 5-day forced-switch from usual brand conventional combustible cigarettes to exclusive use of blu e-cigarettes, dual use of blu e cigarettes and the subject's usual brand combustible cigarette, or smoking cessation. 2. Compare changes in selected urine and blood biomarkers of tobacco exposure among cohorts following a 5-day forced-switch from usual brand conventional combustible cigarettes to exclusive use of a blu e cigarette, dual use of a blu e-cigarette and the subject's usual brand combustible cigarette, or smoking cessation. The secondary objectives of this study are to: 1. Compare changes in selected physiological endpoints affected by tobacco exposure within cohorts during a 5-day forced-switch from usual brand conventional combustible cigarettes to exclusive use of blu e cigarettes, dual use of blu e cigarettes and the subject's usual brand combustible cigarette, or smoking cessation. 2. Compare changes in selected physiological endpoints affected by tobacco exposure among cohorts following a forced-switch to exclusive use of a blu e cigarette, dual use of a blu e-cigarette and the subject's usual brand combustible cigarette, or smoking cessation. 3. Determine daily nicotine consumption from blu e-cigarettes following exclusive use of blu e cigarettes or dual use of blu e-cigarettes and the subject's usual brand combustible cigarette over a 5-day period. 4. Assess the effectiveness of exclusive use of blu e-cigarettes or dual use of blu e-cigarettes and the subject's usual brand combustible cigarette to reduce the urge to smoke. 5. Assess subject opinions of various characteristics of blu e-cigarettes. 6. Assess the safety and tolerability of short-term use of blu e-cigarettes.

Who can participate

Age range21 Years – 65 Years

SexALL

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

Inclusion criteria

✓. Healthy adult male and female smokers, 21 to 65 years of age, inclusive, at Screening.
✓. Combustible cigarette smoker for at least 12 months prior to Check-in. Brief periods of non-smoking during the 90 to 14 days prior to Check-in (e.g., up to \~7 consecutive days due to illness, trying to quit, participation in a study where smoking was prohibited) will be permitted at the discretion of the Investigator.
✓. Currently smokes an average of 10 or more king size (\~83 - 85 mm) or 100s (\~98 - 100 mm) manufactured combustible cigarettes per day (any brand style).
✓. Consistent use of a single brand style for 14 days prior to Check-in.
✓. Positive urine cotinine at Screening (≥ 500 ng/mL).
✓. Exhaled CO \> 12 ppm at Screening.
✓. Female subjects of non-childbearing potential and of childbearing potential will be eligible. Examples of acceptable forms of contraception include, but are not limited to, the following.
✓. Understands the study procedures and provides voluntary consent to participate in the study documented on the signed ICF.

Exclusion criteria

What they're measuring

Biomarkers of tobacco exposure as measured in urine

Timeframe: 5 days

Biomarkers of tobacco effect as measured in urine

Timeframe: 5 days

Biomarkers of tobacco exposure as measured in blood

Timeframe: 5 days

Trial details

NCT IDNCT02385227

SponsorLorillard Tobacco Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-12

View on ClinicalTrials.gov More Cigarette Smoking trials

Plain-language summary

Who can participate

Age range21 Years – 65 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

✓. Healthy adult male and female smokers, 21 to 65 years of age, inclusive, at Screening.
✓. Combustible cigarette smoker for at least 12 months prior to Check-in. Brief periods of non-smoking during the 90 to 14 days prior to Check-in (e.g., up to \~7 consecutive days due to illness, trying to quit, participation in a study where smoking was prohibited) will be permitted at the discretion of the Investigator.
✓. Currently smokes an average of 10 or more king size (\~83 - 85 mm) or 100s (\~98 - 100 mm) manufactured combustible cigarettes per day (any brand style).
✓. Consistent use of a single brand style for 14 days prior to Check-in.
✓. Positive urine cotinine at Screening (≥ 500 ng/mL).
✓. Exhaled CO \> 12 ppm at Screening.
✓. Female subjects of non-childbearing potential and of childbearing potential will be eligible. Examples of acceptable forms of contraception include, but are not limited to, the following.
✓. Understands the study procedures and provides voluntary consent to participate in the study documented on the signed ICF.