Cigarette Packaging of Low Nicotine Cigarettes

• ClinicalTrials.gov Identifier: NCT03802019
• Recruitment Status: Recruiting
• First Posted: January 14, 2019
• Last Update Posted: May 6, 2021
• Sponsor: Andrew Strasser
• Collaborators: Food and Drug Administration (FDA); National Cancer Institute (NCI); University of Pennsylvania
• Information provided by (Responsible Party): Andrew Strasser, University of Pennsylvania

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Smoking, Cigarette	Other: LNC Cigarettes + Colored Packaging; Other: Own Brand	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 575 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 (Participant)
• Masking Description: Participants will be informed that they will be supplied with study cigarettes with a low nicotine content, but will be blinded to the exact nicotine content and unaware that all packages will contain the same type of low nicotine content cigarette.
• Primary Purpose: Other
• Official Title: The Effects of Cigarette Package Color on Smoking Behavior, Exposure and Risk Perception When Using Low Nicotine Content Cigarettes
• Actual Study Start Date: September 18, 2019
• Estimated Primary Completion Date: May 2023
• Estimated Study Completion Date: May 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Own Brand; 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).	Other: Own Brand; 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).
Experimental: LNC Cigarettes + Gray Packaging; 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).	Other: LNC Cigarettes + Colored Packaging; 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.
Experimental: LNC Cigarettes + Red Packaging; 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.	Other: LNC Cigarettes + Colored Packaging; 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.
Experimental: LNC Cigarettes + Blue Packaging; 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.	Other: LNC Cigarettes + Colored Packaging; 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.
Experimental: LNC Cigarettes + Plain Packaging; 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.	Other: LNC Cigarettes + Colored Packaging; 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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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).
5. 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).

Secondary Outcome Measures :

1. Subjective Cigarette Ratings (Visual Analog Scale [VAS] of Cigarette Characteristics) [ Time Frame: Days 0, 5, 10, 20 and 35 ]
   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.
2. Cigarette Risk Beliefs [ Time Frame: Days 0, 5, 20, and 35 ]
   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.
3. Cigarette Craving (Questionnaire on Smoking Urges [QSU]) [ Time Frame: Days 0, 5, 10, 20 and 35 ]
   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).
4. Cigarette Withdrawal (Withdrawal Symptom Checklist [WSC]) [ Time Frame: : Days 0, 5, 10, 20 and 35 ]
   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).
5. Total Puff Count [ Time Frame: Day 0 through Day 35 ]
   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.
6. Puff Duration [ Time Frame: Day 0 through Day 35 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).
• Able to use a computer or related technology (such as a smartphone or tablet).
• Own a computer or related technology (such as a smart phone or tablet) with video camera abilities, reliable internet access and willing to use the device to participate in the research study.
• Have a valid email address and willing to use email to participate in the research study. Participants without an existing email account who are willing to create one for study purposes are eligible to participate.

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.

Contacts and Locations

Contacts

Contact: Catherine Kreider; 215-746-2631; cathk@pennmedicine.upenn.edu

Contact: Valentina Souprountchouk; 215-746-3602; vsoup@pennmedicine.upenn.edu

Locations

United States, Pennsylvania

Center for Interdisciplinary Research for Nicotine Addiction; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contact: Catherine Kreider

Sponsors and Collaborators

Andrew Strasser

Food and Drug Administration (FDA)

National Cancer Institute (NCI)

University of Pennsylvania

Investigators

• Principal Investigator: Andrew Strasser, Ph.D.; University of Pennsylvania

More Information

• Responsible Party: Andrew Strasser, Associate Professor, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03802019
• Other Study ID Numbers: 832540; 1U54CA229973 ( U.S. NIH Grant/Contract )
• First Posted: January 14, 2019
• Last Update Posted: May 6, 2021
• Last Verified: April 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andrew Strasser, University of Pennsylvania:

Smoking Behavior