Smoking, CigaretteNCT03802019
Cigarette Packaging of Low Nicotine Cigarettes
A study testing LNC Cigarettes + Colored Packaging and Own Brand in people with Smoking, Cigarette, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Smoking, Cigarette
- What is being tested?
- LNC Cigarettes + Colored Packaging and Own Brand
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2019to 27 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Interdisciplinary Research for Nicotine Addiction
Philadelphia, Pennsylvania, 19104
About this study
Official title: The Effects of Cigarette Package Color on Smoking Behavior, Exposure and Risk Perception When Using Low Nicotine Content Cigarettes
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.
Read the 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 subjective ratings of cigarettes. The investigators will aim to recruit and randomize 500 daily smokers (~250 male, ~250 female) in a 35-day protocol. After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive either their own preferred brand (control), or LNC cigarettes in one of four types of packaging: standard investigational (gray packaging); red, or blue (tobacco industry strategy); or plain packaging (tobacco control strategy). Participants will be asked to attend 5 in-person sessions at the Center for Interdisciplinary Research on Nicotine Addiction (CIRNA) on Days 0, 5, 10, 20 \& 35. At Intake and Days 15, 25 and 30 participants will complete sessions with research staff remotely (i.e. by video call). Sessions will occur every 4-6 days, for a total of 5 in-person and 4 remote sessions across 35 days.
- Conditions
- Smoking, Cigarette
- Being tested
- LNC Cigarettes + Colored Packaging, Own Brand
- Keywords
- Smoking Behavior
- Medical subject headings
- Cigarette Smoking, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LNC Cigarettes + Colored PackagingOther
After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive low nicotine content cigarettes in one of four types of packaging: gray, red, blue, or plain.
Own BrandOther
After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive their own preferred brand of cigarette (i.e., control).
| Study group | Role | What they receive |
|---|---|---|
| Own Brand | Experimental | After completing a 5-day baseline period of smoking their own brand, participants will complete a 30-day experimental period when they will continue to receive their own preferred brand of cigarettes (i.e., control group). Receives: Other: Own Brand |
| LNC Cigarettes + Gray Packaging | Experimental | After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive low nicotine content cigarettes in standard investigational packaging (gray). Receives: Other: LNC Cigarettes + Colored Packaging |
| LNC Cigarettes + Red Packaging | Experimental | After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive low nicotine content cigarettes in red packaging. Receives: Other: LNC Cigarettes + Colored Packaging |
| LNC Cigarettes + Blue Packaging | Experimental | After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive low nicotine content cigarettes in blue packaging. Receives: Other: LNC Cigarettes + Colored Packaging |
| LNC Cigarettes + Plain Packaging | Experimental | After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive low nicotine content cigarettes in plain packaging. Receives: Other: LNC Cigarettes + Colored Packaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Cigarette Consumption
Daily cigarette consumption will be assessed by participant self-report and verified through collection of spent filters for all cigarettes smoked throughout the entire 35-day study.
Measured: Day 0 through Day 35
Total Puff Volume/Puff Duration
Total puff volume/puff duration (the sum of all puff volumes/duration per cigarette) will be collected for each cigarette smoked during each laboratory session using a standardized video scoring procedure. Total puff volume will be assessed for each cigarette smoked at in-person and remote sessions throughout the entire 35-day study.
Measured: Day 0 through Day 35
Carbon Monoxide (CO)
The investigators will assess CO (measured in parts per million [ppm]), a measure of toxicant exposure, at the onset of each session, as well as before and after each cigarette smoked during each in-person laboratory session. CO collected at the onset of each session represents daily exposure, while CO boost - the change in CO values before and after smoking a cigarette - estimates smoke exposure due to smoking an individual cigarette.
Measured: Days 0, 5, 10, 20 and 35
Total Nicotine Equivalents
Urine collected at Day 5 and Day 35 will be assessed for changes in total nicotine equivalents, nicotine plus its primary metabolites, across the experimental study period (Days 5-35). Total nicotine equivalents will be measured in nanograms per milliliter (ng per mL).
Measured: Days 5 and 35
Total NNAL
Urine collected at D5 and D35 will be assessed for changes in NNAL, a biomarker of carcinogen exposure, across the experimental study period (Days 5-35). Total NNAL will be measured in nanograms per milliliter (ng per mL).
Measured: Days 5 and 35
Secondary outcomes (6)
Subjective Cigarette Ratings (Visual Analog Scale [VAS] of Cigarette Characteristics)
Participants will provide subjective ratings of each cigarette smoked during each in-person laboratory session using a 14-item, 100 mm visual analog scale (VAS) of cigarette characteristics. Anchors are item-specific (e.g., taste: 0 = "very bad," 100 = "very good"), with lower scores indicating less favorable ratings.
Measured: Days 0, 5, 10, 20 and 35
Cigarette Risk Beliefs
To assess risk beliefs about the assigned cigarettes, the investigators will use an 8-item, 5-point scale (1 = definitely untrue; 5 = definitely true) including previously validated items (i.e., "Compared to your own cigarettes, the cigarettes you are currently smoking: are lower in nicotine"). The Cigarette Risk Beliefs questionnaire will be administered at Session 1 (Day 0) before the lab cigarette (18-item baseline version), Session 2 (Day 5) before lab cigarette 1 and 2, Session 5 (Day 20) before the lab cigarette, and Session 8 (Day 35) before the lab cigarette.
Measured: Days 0, 5, 20, and 35
Cigarette Craving (Questionnaire on Smoking Urges [QSU])
Participants will report cigarette craving at the onset of each in-person session. Craving will be assessed using a summary score and two factor subscales (i.e., desire to smoke and craving due to anticipation of negative affect relief) from a 32-item Questionnaire on Smoking Urges (QSU). Participants will respond to each item along a 7-point scale (1=Strongly disagree; 7=Strongly agree).
Measured: Days 0, 5, 10, 20 and 35
Cigarette Withdrawal (Withdrawal Symptom Checklist [WSC])
Participants will report cigarette withdrawal at the onset of each in-person session. Withdrawal will be assessed using a summary score from the 20-item (21 items at Session 1 [Day 0]) revised version of the Withdrawal Symptom Checklist with a one-week frame of reference (WSC-W). Specifically, participants will respond regarding to how they felt in regards to each potential withdrawal symptom along a 4-point scale (0=Not Present; 3=Severe).
Measured: : Days 0, 5, 10, 20 and 35
Total Puff Count
Participants will be video recorded while smoking each lab cigarette in order to collect smoking topography data. During remote sessions, participants will be asked to record a video of their smoking to collect smoking topography data. We have previously used a procedure where we score digital files (video recorded) smoking sessions that has good reliability and consistency (ICCs >.55) for number of puffs taken, interpuff interval, total time lit, and amount smoked (by mass and length), and propose to quantify cigarette smoking behavior using the same procedures.
Measured: Day 0 through Day 35
Puff Duration
Participants will be video recorded while smoking each lab cigarette in order to collect smoking topography data. During remote sessions, participants will be asked to record a video of their smoking to collect smoking topography data. We have previously used a procedure where we score digital files (video recorded) smoking sessions that has good reliability and consistency (ICCs >.55) for number of puffs taken, interpuff interval, total time lit, and amount smoked (by mass and length), and propose to quantify cigarette smoking behavior using the same procedures.
Measured: Day 0 through Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start18 Sep 2019
- Primary completion27 Aug 2025
- Study completion27 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking, CigaretteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This project will recruit current, daily cigarette smokers to a 35-day, randomized, controlled, parallel design protocol. After a 5-day period of smoking their own preferred brand cigarettes, participants will be randomized to a 30-day experimental period when they will receive either their own preferred brand (control group), or LNC cigarettes in one of four types of packaging: standard investigational (current gray packaging); red, or blue (tobacco industry strategy); or plain packaging (tobacco control strategy), for 30 days.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA), National Cancer Institute (NCI), University of Pennsylvania
- Responsible party
- Sponsor
- Investigators
- Andrew Strasser, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802019
- Sponsor's protocol ID
- UPCC 13019
- Other IDs
- 1U54CA229973, 832540
- Status last verified
- Feb 2026
- First submitted
- 4 Jan 2019
- Last updated
- 23 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cigarette Package Color on Smoking Behavior, Exposure and Risk Perception When Using Low Nicotine Content Cigarettes
- ClinicalTrials.gov ID
- NCT03802019
- Acronym / sponsor ID
- UPCC 13019
- Conditions
- Smoking, Cigarette
- Keywords
- Smoking Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA), National Cancer Institute (NCI), University of Pennsylvania
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 27 Aug 2025 (actual)
- Study completion
- 27 Aug 2025 (actual)
- First posted
- 14 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 subjective ratings of cigarettes. The investigators will aim to recruit and randomize 500 daily smokers (~250 male, ~250 female) in a 35-day protocol. After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive either their own preferred brand (control), or LNC cigarettes in one of four types of packaging: standard investigational (gray packaging); red, or blue (tobacco industry strategy); or plain packaging (tobacco control strategy). Participants will be asked to attend 5 in-person sessions at the Center for Interdisciplinary Research on Nicotine Addiction (CIRNA) on Days 0, 5, 10, 20 \& 35. At Intake and Days 15, 25 and 30 participants will complete sessions with research staff remotely (i.e. by video call). Sessions will occur every 4-6 days, for a total of 5 in-person and 4 remote sessions across 35 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
- Model description
- This project will recruit current, daily cigarette smokers to a 35-day, randomized, controlled, parallel design protocol. After a 5-day period of smoking their own preferred brand cigarettes, participants will be randomized to a 30-day experimental period when they will receive either their own preferred brand (control group), or LNC cigarettes in one of four types of packaging: standard investigational (current gray packaging); red, or blue (tobacco industry strategy); or plain packaging (tobacco control strategy), for 30 days.
| Arm | Type | Receives |
|---|---|---|
| Own Brand | Experimental | Other: Own BrandAfter completing a 5-day baseline period of smoking their own brand, participants will complete a 30-day experimental period when they will continue to receive their own preferred brand of cigarettes (i.e., control group). |
| LNC Cigarettes + Gray Packaging | Experimental | Other: LNC Cigarettes + Colored PackagingAfter completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive low nicotine content cigarettes in standard investigational packaging (gray). |
| LNC Cigarettes + Red Packaging | Experimental | Other: LNC Cigarettes + Colored PackagingAfter completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive low nicotine content cigarettes in red packaging. |
| LNC Cigarettes + Blue Packaging | Experimental | Other: LNC Cigarettes + Colored PackagingAfter completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive low nicotine content cigarettes in blue packaging. |
| LNC Cigarettes + Plain Packaging | Experimental | Other: LNC Cigarettes + Colored PackagingAfter completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive low nicotine content cigarettes in plain packaging. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LNC Cigarettes + Colored PackagingAfter completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive low nicotine content cigarettes in one of four types of packaging: gray, red, blue, or plain. | Other | LNC Cigarettes + Blue Packaging, LNC Cigarettes + Gray Packaging, LNC Cigarettes + Plain Packaging, LNC Cigarettes + Red Packaging |
| Own BrandAfter completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive their own preferred brand of cigarette (i.e., control). | Other | Own Brand |
Primary outcome
Daily Cigarette Consumption
Time frame: Day 0 through Day 35
Daily cigarette consumption will be assessed by participant self-report and verified through collection of spent filters for all cigarettes smoked throughout the entire 35-day study.
Total Puff Volume/Puff Duration
Time frame: Day 0 through Day 35
Total puff volume/puff duration (the sum of all puff volumes/duration per cigarette) will be collected for each cigarette smoked during each laboratory session using a standardized video scoring procedure. Total puff volume will be assessed for each cigarette smoked at in-person and remote sessions throughout the entire 35-day study.
Carbon Monoxide (CO)
Time frame: Days 0, 5, 10, 20 and 35
The investigators will assess CO (measured in parts per million [ppm]), a measure of toxicant exposure, at the onset of each session, as well as before and after each cigarette smoked during each in-person laboratory session. CO collected at the onset of each session represents daily exposure, while CO boost - the change in CO values before and after smoking a cigarette - estimates smoke exposure due to smoking an individual cigarette.
Total Nicotine Equivalents
Time frame: Days 5 and 35
Urine collected at Day 5 and Day 35 will be assessed for changes in total nicotine equivalents, nicotine plus its primary metabolites, across the experimental study period (Days 5-35). Total nicotine equivalents will be measured in nanograms per milliliter (ng per mL).
Total NNAL
Time frame: Days 5 and 35
Urine collected at D5 and D35 will be assessed for changes in NNAL, a biomarker of carcinogen exposure, across the experimental study period (Days 5-35). Total NNAL will be measured in nanograms per milliliter (ng per mL).
6 secondary outcomes
Subjective Cigarette Ratings (Visual Analog Scale [VAS] of Cigarette Characteristics)
Time frame: Days 0, 5, 10, 20 and 35
Cigarette Risk Beliefs
Time frame: Days 0, 5, 20, and 35
Cigarette Craving (Questionnaire on Smoking Urges [QSU])
Time frame: Days 0, 5, 10, 20 and 35
Cigarette Withdrawal (Withdrawal Symptom Checklist [WSC])
Time frame: : Days 0, 5, 10, 20 and 35
Total Puff Count
Time frame: Day 0 through Day 35
Puff Duration
Time frame: Day 0 through Day 35
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Strasser, Ph.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LNC Cigarettes + Colored Packaging and Own Brand in people with Smoking, Cigarette, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Cigarette Consumption (time frame: Day 0 through Day 35). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026; AzTrials last refreshed its copy on 30 Oct 2026.