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| ID | Type | Description | Link |
|---|---|---|---|
| 1K07CA218366-01A1 | U.S. NIH Grant/Contract | View source | |
| 829101 | Other Identifier | University of Pennsylvania IRB number |
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Unable to recruit participants
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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The purpose of this study is to look at the effects of investigational low nicotine cigarettes on young adult smokers. The investigators are interested in how using these products affects young adults' perceptions and smoking behaviors. This research may help inform the Food and Drug Administration (FDA) how best to regulate tobacco products in the future with the goal of improving public health.
Investigators will recruit 100 young adult cigarette smokers to a 40-day, laboratory-based protocol. You will provide and smoke your preferred brand cigarettes for an initial 5-day baseline period, then receive your own brand free-of-charge for an additional 5-day period, and then will receive free, investigational low nicotine cigarettes for the remaining study duration (i.e., 30 days total). Low nicotine cigarettes will be provided in three varieties; each variety will be used for a 10-day period, in counterbalanced order. Primary outcomes will include smoking behaviors (daily cigarette consumption and total puff volume), harm perceptions (i.e., beliefs about product safety), and tobacco exposure (i.e., carbon monoxide [CO]). You will complete in-person visits at the Center for Interdisciplinary Research on Nicotine Addiction (CIRNA) every 5 days, for a total of nine in-person visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Purple | Experimental | Participants will receive cigarettes with intermediate or very low nicotine content in purple packaging |
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| White | Experimental | Participants will receive cigarettes with intermediate or very low nicotine content in white packaging |
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| Black | Experimental | Participants will receive cigarettes with intermediate or very low nicotine content in black packaging |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine content | Other | Study-supplied cigarettes will contain either intermediate or very low nicotine content |
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| Measure | Description | Time Frame |
|---|---|---|
| Daily cigarette consumption | Daily cigarette consumption will be assessed primarily by participant self-report and secondarily through collection of spent filters for all cigarettes smoked during the 35-day study period, and will be averaged across baseline and pack color periods. | Days 0 through 40 |
| Measure | Description | Time Frame |
|---|---|---|
| Total puff volume | Total puff volume (total smoke inhaled per cigarette) will be collected twice during laboratory visits using a handheld, portable, electronic topography device. Assessments will be averaged across study periods. | Days 0, 5, 10, 15, 20, 25, 30, 35, and 40 |
| Risk perceptions |
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Inclusion Criteria:
Study participants will be 100 male and female young adult smokers who:
Exclusion Criteria:
We will exclude those who:
Additional, general reasons for exclusion include:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Mercincavage, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Randomized, single-blind, 2 x 4 mixed factorial design laboratory-based study manipulating: (1) cigarette pack color (4-level within-subjects factor: own brand vs. white vs. purple vs. black color), and (2) nicotine content (2-level between-subjects factor: moderate vs. very low nicotine content). All participants will provide and smoke their preferred brand for an initial 5-day baseline period, receiver their own brand free-of-charge for 5-days, and then will be randomly assigned to smoke either intermediate or very low LNC cigarettes for the study duration. We will supply participants with LNC cigarettes in three pack colors; each color will be used for a 10-day period, in counter-balanced order.
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Participants will be informed that they will be supplied cigarettes with low nicotine content but will be blinded to exact nicotine content and unaware that within-subject, all packages will contain the same type of low nicotine cigarette
Perceptions of risks of using study cigarettes will be assessed at the end of own brand and pack color periods using individual items and a summary score from an 8-item, 5-point Likert scale (1 = "definitely untrue", 5 = "definitely true") stating: "Compared to your own cigarettes, the cigarettes you are currently smoking…": a) "are lower in nicotine", b) "are lower in tar", c) "are less addictive", d) "are less likely to cause cancer", e) "have fewer chemicals", f) "are healthier", g) "make smoking safer", h) "help people quit smoking." |
| Days 10, 20, 30, and 40 |
| Harm exposure | Harm exposure will be approximated by changes in expired air carbon monoxide (CO), a commonly used biochemical measure of tobacco smoke exposure that is sensitive to changes in puffing behavior. We will assess CO at the onset of each visit to represent daily exposure, as well as before and after each cigarette smoked during laboratory visits. The change in CO values resulting from smoking a cigarette will estimates smoke exposure due to smoking an individual cigarette. | Days 0, 5, 10, 15, 20, 25, 30, 35, and 40 |