Young Adults and Low Nicotine Cigarettes



Status:Not yet recruiting
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 25
Updated:4/6/2019
Start Date:May 2019
End Date:September 2020
Contact:Melissa Mercincavage, PhD
Email:melmer@pennmedicine.upenn.edu
Phone:215-746-7285

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The purpose of this study is to look at the effects of investigational low nicotine
cigarettes on young adult smokers. The investigators are interested in how using these
products affects young adults' perceptions and smoking behaviors. This research may help
inform the Food and Drug Administration (FDA) how best to regulate tobacco products in the
future with the goal of improving public health.

Investigators will recruit 100 young adult cigarette smokers to a 35-day, laboratory-based
protocol. You will provide and smoke your preferred brand cigarettes for an initial 5-day
baseline period, and then will be provided with free, investigational low nicotine cigarettes
for the study duration (i.e., 30 days total). Low nicotine cigarettes will be provided in
three pack colors; each color will be used for a 10-day period, in counterbalanced order.
Primary outcomes will include smoking behaviors (daily cigarette consumption and total puff
volume), harm perceptions (i.e., beliefs about product safety), and tobacco exposure (i.e.,
carbon monoxide [CO]). You will complete in-person visits at the Center for Interdisciplinary
Research on Nicotine Addiction (CIRNA) every 5 days, for a total of eight in-person visits.

Inclusion Criteria:

- Study participants will be 100 male and female young adult smokers who:

- Are aged 18-25

- Report smoking ≥ 100 lifetime cigarettes

- Report smoking at least 1 non-menthol, filtered cigarette per day on all or most
days during the past 30 days

Exclusion Criteria:

- We will exclude those who:

- Plan to quit smoking in the next month

- Smoke menthol cigarettes > 80% of the time

- Report consuming ≥ 25 alcohol-containing drinks per week

- Report a history or current psychiatric diagnosis or severe medical condition,

- Are color-blind or have another visual impairment (e.g., partial blindness,
uncorrected cataract)

- Are pregnant and/or lactating

Additional, general reasons for exclusion include:

- Significant non-compliance with protocol and/or study design as determined by the
Principal Investigator and/or Study Physician. Subjects may be deemed ineligible at
any point throughout the study.

- Past, current, anticipated, or pending enrollment in another research program over the
study period that could potentially impact subject safety, study data, and/or the
study design as determined by the Principal Investigator and/or Study Physician.

- Any medical condition, illness, disorder, adverse event (AE), or concomitant
medication that could compromise participant safety or significantly impact study
performance as determined by the Principal Investigator and/or Study Physician.
Subjects may be deemed ineligible for any of the aforementioned reasons at any point
throughout the study, as well as during the initial telephone screen.
We found this trial at
1
site
Philadelphia, Pennsylvania 19104
Principal Investigator: Melissa Mercincavage, PhD
Phone: 215-746-7285
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mi
from
Philadelphia, PA
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