Comparison of Nicotine Plasma Concentrations and Subjective Effects for Three Electronic Cigarettes vs Combustible Cigarettes and Nicotine Gum



Status:Completed
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:21 - 60
Updated:6/6/2018
Start Date:May 2014
End Date:January 2015

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A Single-Center, Randomized, Open-Label, Crossover Study to Assess Elements of Abuse Liability for Three Electronic Cigarettes

The purpose of this study is to measure plasma nicotine uptake parameters, physiological
measures, and subjective effect measures in smokers during and following a single ad libitum
use of three electronic cigarettes versus combustible cigarettes and nicotine gum.

This study will assess various elements that may provide information regarding the potential
for electronic cigarettes (e-cigarettes) to be adopted by current smokers. These various
elements include: a) nicotine pharmacokinetics (PK), b) physiological measures of pulse rate
and blood pressure, and c) subjective effects measured by Urge to Smoke, Product Rating,
Intent to Use Product Again, and Product Effects.

Inclusion Criteria:

1. Able to read, understand, and willing to sign an informed consent form and complete
questionnaires written in English.

2. Generally healthy male or female, 21 to 60 years of age, inclusive, at Screening.

3. Expired breath carbon monoxide (ECO) level is ≥ 15 ppm and ≤ 100 ppm at the Screening
and Randomization Visits, measured between 12 p.m. and 6 p.m.

4. Cigarettes are the only tobacco product used within (≤) 30 days of Screening.

5. Smokes combustible, filtered, non-menthol cigarettes, 83 mm to 100 mm in length.

6. Agrees to smoke usual brand (UB) cigarette throughout the study period. Usual brand
cigarette is defined as the cigarette brand style currently smoked most frequently by
the subject.

7. Smokes at least 10 cigarettes per day (on average) and inhales the smoke, for at least
6 months prior to Screening. Brief periods of abstinence due to illness, quit attempt
(prior to 30 days of Screening), or clinical study participation (prior to 30 days of
Screening) will be allowed at the discretion of the Investigator.

8. Response at Screening to Fagerstrom Test for Nicotine Dependence, Question 1 ("How
soon after you wake up do you smoke your first cigarette?") is either "Within 5
minutes" or "6 - 30 minutes."

9. Willing to use UB cigarette, the study electronic cigarette brand styles and nicotine
gum during the study period.

10. Willing to abstain from tobacco and nicotine use for at least 12 hours prior to
check-in at each Test Visit.

11. Willing to not participate for 60 days post-study in donation of blood samples or in
any study that requires collection of blood samples.

12. Females of childbearing potential must be willing to use a form of contraception
acceptable to the Investigator from the time of signing informed consent until study
discharge.

Exclusion Criteria:

1. Clinically significant or unstable/uncontrolled acute or chronic medical conditions at
Screening, as determined by the Investigator, that would preclude a subject from
participating safely in the study (e.g., uncontrolled hypertension, asthma or other
lung disease, cardiac disease, neurological disease or psychiatric disorders) based on
safety assessments such as clinical laboratory tests, medical history, and
physical/oral examinations.

2. Systolic blood pressure of > 150 mmHg or a diastolic blood pressure of > 95 mmHg at
Screening, measured after being seated for at least 5 minutes.

3. Hemoglobin level is < 12 g/dL at Screening.

4. Positive test for Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen, or
Hepatitis C virus.

5. Postponing a decision to quit smoking (defined as planning a quit attempt within [≤]
30 days of Screening) to participate in this study or previous attempt within (≤) 30
days prior to Screening.

6. Employed by a tobacco company, the study site, or handles unprocessed tobacco as part
of their job.

7. Use of any medication or supplement that aids smoking cessation, including but not
limited to any nicotine replacement therapy (e.g., nicotine gum, lozenge, patch),
varenicline (Chantix), bupropion (Wellbutrin, Zyban), or lobelia extract within (≤) 30
days of Screening.

8. Females ≥ 35 years of age currently using systemic, estrogen containing contraception
or hormone replacement therapy.

9. A positive urine drug screen without disclosure of corresponding prescribed
concomitant medication(s), at Screening or Randomization Visit. A positive alcohol
result at Screening, Randomization Visit, or at any Test Visit.

10. A female who is pregnant, lactating, or intends to become pregnant during the course
of the study.
We found this trial at
1
site
Lincoln, Nebraska 68502
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from
Lincoln, NE
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