Abuse Liability of Reduced Nicotine Content Cigarettes in the Context of Concurrent E-Cigarette Use



Status:Not yet recruiting
Conditions:Smoking Cessation, Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:10/4/2017
Start Date:January 2018
End Date:June 2019
Contact:Tanaia Loeback
Email:tanaia.loeback@roseresearchcenter.com
Phone:9193282345

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Three hundred-twenty (320) adult smokers of menthol or non-menthol combustible cigarettes
will be recruited and randomly assigned to one of five groups (n=64/group), who will be asked
to switch for 12 weeks to ad libitum use of combustible cigarettes (matched to subjects'
menthol preference) containing either 0.4, 1.4, 2.5, 5.6 or 16.9 mg nicotine (standardized
nicotine yields ranging from 0.02-0.80 mg/cigarette), respectively. Each group will include
32 heavy, long-time smokers (≥ 10 cigarettes/day for ≥ 10 years), and 32 light smokers with a
shorter smoking history (<10 cigarettes/day for <10 years), who are hypothesized to be more
sensitive to nicotine's reinforcing effects. Participants will also have free access to
nicotine-containing e-cigarettes (15 mg/ml) throughout the 12-week period. Abuse liability of
combustible cigarettes will be assessed by behavioral (cigarettes/day, time to first
cigarettes), self-report (rewarding effects, withdrawal symptoms) and biochemical indices
(expired air carbon monoxide, cotinine blood sampling).


Inclusion Criteria:

1. Subject is healthy as judged by the Investigator based on all available assessments
from the Screening Period (e.g., safety laboratory, vital signs, physical examination,
ECG, concomitant medications and medical history).

2. Subject smokes on average four days a week for the last 12 months.

3. Subject has no intention of quitting smoking within the next 90 days.

4. Owns a smart phone with text message and data capabilities.

5. Willingness to use and ability to operate e-cigarettes.

6. Willingness to smoke Research Cigarettes.

Exclusion Criteria:

1. Any medical or psychiatric condition (or associated symptoms or medications)
determined by a medical professional to be severe enough to be disruptive to the
study.

2. Severe or uncontrolled psychiatric disease with the exception of anxiety disorders,
obsessive-compulsive disorder (OCD) and attention deficit hyperactivity disorder
(ADHD);

3. Pregnant or nursing (by self-report) or positive pregnancy test;

4. Daily use of:

1. Experimental (investigational) drugs that are unknown to subject;

2. Smokeless tobacco (chewing tobacco, snuff), cigars, pipes and hookah;

3. e-cigarettes;

5. Use in the past 30 days of nicotine replacement therapy or other smoking cessation
product

6. Positive drug screen for cocaine
We found this trial at
2
sites
Charlotte, North Carolina 28262
Principal Investigator: Jed E Rose, Ph.D.
Phone: 704-350-2999
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Charlotte, NC
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Raleigh, North Carolina 27617
Principal Investigator: Jed E Rose, Ph.D.
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Raleigh, NC
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