Effects of cigarette packaging on smoking behavior with low nicotine cigarettes

The Effects of Cigarette Package Color on Smoking Behavior, Exposure and Risk Perception When Using Low Nicotine Content Cigarettes

This study is testing how different colors of cigarette packages affect the smoking habits and risk perceptions of daily smokers using low nicotine cigarettes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 575 (estimated)
• Ages: 21 Years to 65 Years
• Sex: All
• Sponsor: Abramson Cancer Center at Penn Medicine (Academic / other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT03802019 on ClinicalTrials.gov

What this trial studies

This study examines how different cigarette package colors influence smoking behaviors, harm exposure, and risk perceptions among daily smokers using low nicotine content (LNC) cigarettes. It employs a randomized, parallel-design trial involving 500 participants who will be assigned to either their preferred brand or LNC cigarettes in various packaging styles over a 30-day period. Participants will attend both in-person and remote sessions to assess their smoking habits and perceptions throughout the study. The goal is to understand how packaging can affect smoking behavior and perceptions of harm.

Who should consider this trial

Good fit: Ideal candidates are daily smokers who have been smoking at least 5 non-menthol cigarettes per day for the past year and are not currently seeking cessation treatment.

Not a fit: Patients who smoke menthol cigarettes or are planning to quit smoking during the study period may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved public health strategies for reducing smoking rates and harm associated with cigarette use.

How similar studies have performed: Other studies have explored the impact of cigarette packaging on smoking behavior, suggesting that packaging can influence perceptions and behaviors, though this specific approach with LNC cigarettes is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Philadelphia, Pennsylvania

• Center for Interdisciplinary Research for Nicotine Addiction — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Andrew Strasser, Ph.D. — University of Pennsylvania
• Study coordinator: Catherine Kreider

Conditions Smoking, Cigarette; Smoking Behavior