Status:
COMPLETED
Characterization of Nicotine Exposure and Urge-to-Smoke Following Use of Electronic and Conventional Cigarettes
Lead Sponsor:
Lorillard Tobacco Company
Conditions:
Smoking
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
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...
Detailed Description
This was a randomized, partially single-blinded, 6-period crossover study of 24 subjects. The primary objectives of this study were to: 1. characterize the rate and extent of nicotine exposure follo...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02210754
Start Date
March 1 2014
End Date
July 1 2014
Last Update
August 7 2014
Active Locations (1)
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1
Celerion
Lincoln, Nebraska, United States, 68502