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

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ClinicalTrials.gov Identifier: NCT02210754
Recruitment Status : Completed
First Posted : August 7, 2014
Last Update Posted : August 7, 2014
Sponsor:
Information provided by (Responsible Party):
Lorillard Tobacco Company

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').

Condition or disease Intervention/treatment Phase
Smoking Other: blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin vehicle) Other: blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/PG vehicle) Other: blu™ Magnificent Menthol rechargeable (2.4% nicotine, glycerin vehicle) Other: blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin vehicle) Other: blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin/PG vehicle) Other: Marlboro Cigarette Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Official Title: Characterization of Nicotine Exposure and Urge-to-Smoke Following a Single Controlled Administration and Short-Term Ad Lib Use of Electronic Cigarettes and Conventional Cigarettes in Adult Smokers
Study Start Date : March 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes Smoking

Arm Intervention/treatment
Experimental: E-cigarette 1
blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin vehicle)
Other: blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/PG vehicle)
electronic cigarettes

Other: Marlboro Cigarette
cigarettes

Experimental: E-cigarette 2
blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/propylene glycol (PG) vehicle)
Other: blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin vehicle)
electronic cigarettes

Other: blu™ Magnificent Menthol rechargeable (2.4% nicotine, glycerin vehicle)
electronic cigarettes

Other: blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin/PG vehicle)
electronic cigarettes

Other: Marlboro Cigarette
cigarettes

Experimental: E-cigarette 3
blu™ Magnificent Menthol rechargeable (2.4% nicotine, glycerin vehicle)
Other: blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/PG vehicle)
electronic cigarettes

Other: Marlboro Cigarette
cigarettes

Experimental: E-cigarette 4
blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin vehicle)
Other: blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin/PG vehicle)
electronic cigarettes

Other: Marlboro Cigarette
cigarettes

Experimental: E-cigarette 5
blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin/PG vehicle)
Other: blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/PG vehicle)
electronic cigarettes

Other: blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin vehicle)
electronic cigarettes

Other: Marlboro Cigarette
cigarettes

Active Comparator: Combustible Cigarette
Marlboro Cigarette
Other: blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin vehicle)
electronic cigarettes

Other: blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/PG vehicle)
electronic cigarettes

Other: blu™ Magnificent Menthol rechargeable (2.4% nicotine, glycerin vehicle)
electronic cigarettes

Other: blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin vehicle)
electronic cigarettes

Other: blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin/PG vehicle)
electronic cigarettes




Primary Outcome Measures :
  1. Profile nicotine pharmacokinetics following use of e-cigs and regular cigarettes [ Time Frame: 6 months ]
    Measure plasma nicotine PK outcome measures such as Peak Plasma Concentration and Area under the Plasma Concentration versus time curve.


Secondary Outcome Measures :
  1. Assess smoking urge scores on the Visual Analog Scale following use of electronic and regular cigarettes [ Time Frame: 6 months ]
    Smoking urge was assessed using a 100 mm visual analog scale (VAS). Assessments occurred within 1 minute prior to the -10 (pre-product administration), 5, 15, 25, 30, 60, and 90-minute PK blood draws on Days 1, 3, 5, 7, 9, and 11. The 30-minute assessment was intended to coincide with the start of the ad lib product use. The following non-compartmental pharmacodynamic parameters were calculated from the smoking urge change-from-baseline data: Maximum smoking urge reduction and change-from-baseline from time zero to 30 minutes, area under the effect curve (smoking urge change-from-baseline) from time 0 to 30 minutes and 30 to 90 minutes,time of the maximum (positive or negative) smoking urge change-from-baseline from time 0 to 30 minutes and Observed smoking urge change-from-baseline at 90 minutes.


Other Outcome Measures:
  1. Evaluation of the Number of Participants with Adverse Effects, Vital Signs, and Concomitant Medications [ Time Frame: 6 months ]
    AE seriousness, severity, and relationship to study product were assessed.



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210754


Locations
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United States, Nebraska
Celerion
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Lorillard Tobacco Company
Investigators
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Principal Investigator: Michael R. Gartner, MD Celerion

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lorillard Tobacco Company
ClinicalTrials.gov Identifier: NCT02210754     History of Changes
Other Study ID Numbers: Galileo
First Posted: August 7, 2014    Key Record Dates
Last Update Posted: August 7, 2014
Last Verified: August 2014

Keywords provided by Lorillard Tobacco Company:
Nicotine
Pharmacokinetics
Pharmacodynamics
blu e-cigs
Tolerability
Safety
Smoke urge

Additional relevant MeSH terms:
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Nicotine
Menthol
Glycerol
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents
Cryoprotective Agents
Protective Agents