Completed

SKY PilotAcute Effects of Cigarette Packaging and Charcoal Filtration on Perceptions, Use Behaviors, and Harm Exposure

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What is being tested

Charcoal-filtered cigarette

+ Non-charcoal filtered cigarette

Other
Who is being recruted

From 21 to 60 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: March 2022
See protocol details

Summary

Principal SponsorAbramson Cancer Center at Penn Medicine
Last updated: December 13, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: March 10, 2022

Actual date on which the first participant was enrolled.

We will recruit 40 adult daily, non-menthol smokers to a single 2-hr laboratory study where they will smoke two study-provided \[commercially available\] cigarettes, each for a 10-min ad lib period, and then complete product perception and use measures. Smoking sessions will be video recorded and scored to capture puffing behavior, and carbon monoxide (CO) assessments will be collected before and after smoking to assess changes in acute smoke exposure. We will use a 2 x 2 mixed factorial design to manipulate the study-provided cigarette's packaging (between subject factor: light colored 'Sky' package vs. black NAS package; both industry-made) and filter type (within-subject factor: charcoal filter vs. non-charcoal filter; cigarettes will appear identical despite differences in filter composition). Primary outcomes will be product perceptions (risk perceptions, subjective ratings), use behaviors (puffing behavior and purchase task), and acute toxicant exposure (changes in CO).

Official TitleAcute Effects of Cigarette Packaging and Charcoal Filtration on Perceptions, Use Behaviors, and Harm Exposure 
NCT05157048
Principal SponsorAbramson Cancer Center at Penn Medicine
Last updated: December 13, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

42 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: * Male and female smokers who are between 21 and 60 years of age and self-report smoking at least 5 cigarettes per day for at least the past 12 months. * Smokers of primarily non-menthol cigarettes. * Not currently undergoing smoking cessation treatment or trying to quit. * Able to communicate fluently in English (speaking, writing, and reading). * Capable of giving written informed consent. Exclusion Criteria: Subjects who self-report and/or present with the following criteria will not be eligible to participate in the study: Smoking Behavior 1. Use of menthol cigarettes as preferred/regular brand (defined as using \>20% of the time). 2. Use of research cigarettes in the past 6 months (i.e., past 6-month participation in applicable previous CIRNA studies). 3. Enrollment or plans to enroll in a smoking cessation program in the next month. 4. Provide an initial Carbon Monoxide (CO) reading \< 5 parts per million (ppm). Alcohol/Drugs 1. History of substance abuse (other than nicotine) in the past 12 months and/or currently receiving medical treatment for substance abuse. 2. Current alcohol consumption that exceeds 25 standard drinks/week. Medical 1. Women who are pregnant, planning a pregnancy, and/or lactating. 2. Any impairment including, but not limited to, visual, physical, and/or neurological impairments preventing the completion of procedures included within this protocol. Notable impairments will be evaluated by the PI and eligibility will be determined on a case-by-case basis. 3. Color blindness. 4. Serious or unstable disease within the past 12 months (e.g. heart disease, cancer). Applicable conditions will be evaluated by the Principal Investigator and eligibility will be determined on a case-by-case basis. Psychiatric As determined by self-report: 1. Lifetime history or current diagnosis of psychosis, bipolar disorder, and/or schizophrenia. 2. Current diagnosis of major depression. Subjects with a history of major depression, in remission for 6 months or longer, are considered eligible. Other Additionally, participants may be deemed ineligible for any of the following general reasons at any point throughout the study, as well as during the initial telephone screen, at the discretion of the PI: * Significant non-compliance with protocol and/or study design. * Past, current, anticipated, or pending enrollment in another research program over the study period that could potentially impact study data. * Any medical condition, illness, disorder, adverse event (AE), or concomitant medication that could compromise participant safety or significantly impact study performance.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will be randomized to one of two pack color conditions: light or dark. Those in the dark pack color condition will be given Natural American Spirit Black packs.

Group II

Experimental
Participants will be randomized to one of two pack color conditions: light or dark. Those in the light pack color condition will be given Natural American Spirit Sky packs.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania

Philadelphia, United StatesSee the location
CompletedOne Study Center