Characterization of Nicotine Exposure and Urge-to-Smoke Following Use of Electronic and Conventional Cigarettes

Completed · Not applicable

Conditions studied: Smoking

In brief

This trial was the initial characterization of the blu™ products being studied, with the purpose of gaining an understanding of the exposure to nicotine and craving reduction attained following use of blu™ e-cigarettes by adult smokers. Two types of exposures were utilized: a single controlled administration and a short-term ad lib use. As smoking behaviors vary from smoker to smoker, a controlled administration allows for some standardization of nicotine "dose" for each of the study products to better understand their uptake characteristics as well as urge reduction achieved under controlled conditions. Further evaluation under ad lib product use conditions provides insight into product self-administration behaviors that will allow subjects to achieve acceptable levels of urge reduction. Comparisons were made to evaluate differences between blu™ formulations as well as to the market-leading conventional cigarette, Marlboro Gold King Size ("Marlboro cigarette').

Key facts

Study ID

NCT02210754

Run by

Lorillard Tobacco Company

People needed

24

Starts

2014-03-01

Expected to finish

2014-07-01

Last updated by the study team

2014-08-07

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy adult male and female smokers
• 21 to 65 years of age, inclusive, at Screening.
• Smoker for at least 12 months prior to Check-in
• Currently smoked an average of 10 or more manufactured cigarettes per day (no restriction on brand-style, king size [ approx. 83 - 85 mm] and 100s [approximately 98 - 100 mm] only)
• A history of e-cigarette use was allowed.
• Females of childbearing potential agreed to use a PI-approved method of contraception

You may not qualify if…

• Use of tobacco- or nicotine-containing products other than manufactured cigarettes and e-cigarettes (e.g., roll-your-own cigarettes, bidis, snuff, snus, tablets, inhalers, pipes, cigars, chewing tobacco, nicotine replacement therapies [e.g., gum, patches, lozenges, nasal spray, or inhalers]) within 28 days prior to Day 1 product administration or during the study.
• Use of any prescription smoking cessation treatments, including, but not limited to, varenicline (Chantix®) or buproprion (Zyban®) within 3 months prior to Day 1 product administration and throughout the study.
• Known hypersensitivity to menthol, glycerol, or propylene glycol (PG).
• Exhaled CO ≤ 10 ppm at Screening.
• Self-reported puffers (i.e., smokers who draw smoke from the cigarette into the mouth and throat but do not inhale).
• Use of medications known to interact with cytochrome P450 2A6 (including, but not limited to, amiodarone, desipramine, isoniazid, ketoconazole, miconazole, phenobarbital, rifampin, tranylcypromine, and methoxsalen) within 3 months prior to Day 1 product administration.
• History of drug or alcohol abuse within 24 months of Day 1 product administration
• Female subjects who were pregnant, lactating, or intended to become pregnant from Screening through completion of study.

Where it is running

• Celerion — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.