Characterization of Nicotine Exposure and Urge-to-Smoke Following Use of Electronic and Conventional Cigarettes
1 other identifier
interventional
24
1 country
1
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 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').
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 30, 2014
CompletedFirst Posted
Study publicly available on registry
August 7, 2014
CompletedAugust 7, 2014
August 1, 2014
2 months
July 30, 2014
August 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Profile nicotine pharmacokinetics following use of e-cigs and regular cigarettes
Measure plasma nicotine PK outcome measures such as Peak Plasma Concentration and Area under the Plasma Concentration versus time curve.
6 months
Secondary Outcomes (1)
Assess smoking urge scores on the Visual Analog Scale following use of electronic and regular cigarettes
6 months
Other Outcomes (1)
Evaluation of the Number of Participants with Adverse Effects, Vital Signs, and Concomitant Medications
6 months
Study Arms (6)
E-cigarette 1
EXPERIMENTALblu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin vehicle)
E-cigarette 2
EXPERIMENTALblu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/propylene glycol (PG) vehicle)
E-cigarette 3
EXPERIMENTALblu™ Magnificent Menthol rechargeable (2.4% nicotine, glycerin vehicle)
E-cigarette 4
EXPERIMENTALblu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin vehicle)
E-cigarette 5
EXPERIMENTALblu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin/PG vehicle)
Combustible Cigarette
ACTIVE COMPARATORMarlboro Cigarette
Interventions
electronic cigarettes
electronic cigarettes
electronic cigarettes
electronic cigarettes
electronic cigarettes
Eligibility Criteria
You may qualify if:
- Healthy adult male and female smokers
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Celerion
Lincoln, Nebraska, 68502, United States
Related Publications (1)
D'Ruiz CD, Graff DW, Yan XS. Nicotine delivery, tolerability and reduction of smoking urge in smokers following short-term use of one brand of electronic cigarettes. BMC Public Health. 2015 Sep 30;15:991. doi: 10.1186/s12889-015-2349-2.
PMID: 26424091DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael R. Gartner, MD
Celerion
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2014
First Posted
August 7, 2014
Study Start
March 1, 2014
Primary Completion
May 1, 2014
Study Completion
July 1, 2014
Last Updated
August 7, 2014
Record last verified: 2014-08