Characterization of Biomarkers of Tobacco Exposure, Urge-to-Smoke Following Exclusive and Dual Ad… (NCT02385227) | Clinical Trial Compass
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 range
21 Years – 65 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Biomarkers of tobacco exposure as measured in urine
Timeframe: 5 days
2
Biomarkers of tobacco effect as measured in urine
Timeframe: 5 days
3
Biomarkers of tobacco exposure as measured in blood
. 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
. History or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, pulmonary (especially bronchospastic diseases), immunologic, psychiatric, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
. Clinically significant abnormal findings on the physical examination, medical history, ECG, or clinical laboratory results at Screening or Check-in, in the opinion of the Investigator.
. Positive test for HIV, HbsAg, or HCV.
. An acute illness (e.g., upper respiratory infection, viral infection) requiring treatment within 2 weeks prior to Check-in.
. Fever (\>100.2F) at Screening or at Check-in.
. Systolic blood pressure \>150 mmHg, diastolic blood pressure \>95 mmHg, or pulse rate \>99 bpm at Screening.
. BMI \<18 kg/m2 or \>40 kg/m2 at Screening.
. Female subjects who are pregnant, lactating, or intend to become pregnant from Screening through completion of study.