Status:
COMPLETED
Cigarette Packaging of Low Nicotine Cigarettes
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Collaborating Sponsors:
Food and Drug Administration (FDA)
National Cancer Institute (NCI)
Conditions:
Smoking, Cigarette
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
The purpose of this study is to examine the effect of changes in cigarette package color on smoking behaviors, harm exposure, and risk perceptions when using low nicotine content (LNC) cigarettes.
Detailed Description
This project will utilize a randomized, parallel-design trial to examine the effects of low nicotine content (LNC) cigarette packaging on smoking behaviors, harm exposure, risk perceptions, and subjec...
Eligibility Criteria
Inclusion
- Self-report smoking at least 5 non-menthol, filtered cigarettes per day for at least the last 12 months.
- Not currently undergoing smoking cessation treatment or planning to quit over the duration of the study (\~5 weeks).
- Plan to live in the area for the duration of the study.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form.
- Able to communicate fluently in English (i.e., speaking, writing, and reading).
Exclusion
- Smoke menthol cigarettes greater than 20% of the time.
- Smoke cigarettes of non-standard circumference (e.g., wides, slim, capri, etc.)
- Use of any nicotine containing products other than cigarettes. Participants reporting isolated use of other nicotine containing products less than 5 times per month are eligible to participate.
- Attempt to quit smoking over the duration of the study period.
- Provide a Carbon Monoxide (CO) reading less than 5 parts per million (ppm) at Session 1 (D0).
- History of substance abuse (other than nicotine) in the past 12 months and/or currently receiving medical treatment for substance abuse. Attendance at alcoholics anonymous or narcotics anonymous meetings will not be considered medical treatment for the purposes of this protocol.
- Current alcohol consumption that exceeds 25 standard drinks/week.
- Women, including all individuals assigned as "female" at birth, who are pregnant, breast feeding, or planning a pregnancy over the duration of the study period.
- Any impairment including, but not limited to, visual, physical, and/or neurological impairments preventing the proper completion of the study procedures. Notable impairments will be evaluated on a case-by-case basis by the Principal Investigator and/or the Study Physician.
- Color blindness.
- Serious or unstable medical condition. Applicable conditions will be evaluated on a case-by-case basis by the Principal Investigator and/or the Study Physician.
- Lifetime history of schizophrenia, psychosis, and/or bipolar disorder.
- Current diagnosis of active major depression. Participants who maintain a diagnosis of major depression who have not experienced any major depressive episodes in the past 6 months and are stable on antidepressant medication(s) are eligible to participate.
- Additional, general reasons for exclusion include:
- 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 circumstance, 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. Participants may be withdrawn for any of the aforementioned reasons at any point throughout the study.
- Significant non-compliance with protocol and/or study design as determined by the Principal Investigator and/or Study Physician. Participants may be withdrawn at any point throughout the study.
Key Trial Info
Start Date :
September 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2025
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT03802019
Start Date
September 18 2019
End Date
August 27 2025
Last Update
October 14 2025
Active Locations (1)
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1
Center for Interdisciplinary Research for Nicotine Addiction
Philadelphia, Pennsylvania, United States, 19104