Cigarette Packaging of Low Nicotine Cigarettes | NCT03802019

NCT03802019

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
1U54CA229973	U.S. NIH Grant/Contract		View source
832540	Other Identifier	University of Pennsylvania IRB number

Status Module

Name	Class
Food and Drug Administration (FDA)	FED
National Cancer Institute (NCI)	NIH
University of Pennsylvania	OTHER

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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).	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).	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.	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.	Other: LNC Cigarettes + Colored Packaging
LNC Cigarettes + Plain Packaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LNC Cigarettes + Colored Packaging	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	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.	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).	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).	Days 5 and 35

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

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.

ID	Term
D000073865	Cigarette Smoking
D012907	Smoking

ID	Term
D000073869	Tobacco Smoking
D001519	Behavior
D064424	Tobacco Use