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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA120594 | U.S. NIH Grant/Contract | View source | |
| R01CA130961 | U.S. NIH Grant/Contract | View source | |
| P30ES013508 | U.S. NIH Grant/Contract | View source | |
| P50CA143187 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
| National Institute of Environmental Health Sciences (NIEHS) | NIH |
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This study will examine how menthol affects smoking when menthol smokers switch to non-menthol cigarettes. Participants will smoke their preferred brand (control) or Camel Crush cigarettes, which have the ability to be menthol or non-menthol. Participants given Camel Crush cigarettes will smoke them as menthol, then non-menthol cigarettes for 15 days each. Participants will provide breath and urine samples, track cigarette usage and complete smoking topography assessments of smoking behavior.
This study will examine how menthol affects smoking behaviors and biomarker level when menthol smokers switch to non-menthol cigarettes. Participants will initially smoke their preferred brand (control) cigarettes, followed by smoking Camel Crush cigarettes, which have the ability to be menthol or non-menthol. Participants given Camel Crush cigarettes will smoke them as menthol, then non-menthol cigarettes for 15 days each. Participants will provide breath and urine samples to measure smoke exposures, track cigarette usage to establish changes in daily cigarette consumption and complete smoking topography assessments of smoking behavior, such as puff volume.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nonmenthol | Experimental | Participants switch from menthol to non-menthol cigarettes. |
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| Menthol | No Intervention | Participants smoke own brand of menthol cigarettes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Menthol to non-menthol | Other | Switch from smoking menthol to non-menthol cigarettes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Topography- Puff Volume | The total puff volume for a single subject is the sum of puff volumes for a subject's cigarette smoked during the study session. The mean puff volume for the subjects will be used to examine the effect of cigarette menthol on smoking topography. The values provided are the average of subjects at study Day 5 (completion of baseline smoking own cigarettes), Day 20 and Day 35. | over 35 day study period |
| Smoking Topography- Carbon Monoxide Boost | Carbon monoxide content in exhaled breath samples is measured before and after each cigarette smoked during study sessions. CO boost is the amount in parts per million that the subject's CO increases. | Measured before and after each cigarette smoked at study sessions |
| Nicotine Levels | Urine nicotine levels will be measured to examine the effect of cigarette menthol on harm exposure measures. Participants provided samples on the final day of each period. NNK and 1-hop were not analyzed, total nicotine metabolites were assayed. | 35 days |
| Subjective Rating of Cigarettes | Subjects completed a visual analog scale rating each cigarette smoked at each session. Subjects rated characteristics of the cigarette on a scale represented as a continuous horizontal line 10 cm long. Subjects drew an intersecting line to represent their rating. The rating reported is for the taste of the cigarette at the end of the period averaged across subjects in the group. A rating of 0 corresponds to Very Bad and a rating of 100 to Very Good for taste. There is no better or worse outcome for higher or lower ratings for taste. | Immediately after a cigarette smoked at the study session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew A Strasser, Ph.D. | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23334588 | Background | Strasser AA, Ashare RL, Kaufman M, Tang KZ, Mesaros AC, Blair IA. The effect of menthol on cigarette smoking behaviors, biomarkers and subjective responses. Cancer Epidemiol Biomarkers Prev. 2013 Mar;22(3):382-9. doi: 10.1158/1055-9965.EPI-12-1097. Epub 2013 Jan 18. |
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Subjects were required to complete a 5 day baseline assessment of smoking their own brand cigarette. Participants who did this were given study cigarettes. 87 participants signed consents at the first session, 3 did not finish the session. 60 subjects did the 5 day baseline smoking, returned on Day 5, were randomized and included for analysis.
Participants were recruited from the local Philadelphia area via newspaper and internet advertising. Former study participants who had agreed to be contacted for future studies were also contacted. Recruitment began October 2010 and was completed November 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Control group: continued to smoke same, own brand cigarette. |
| FG001 | Experimental | Menthol to non-menthol : Switch from smoking menthol to non-menthol cigarettes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | Group switched from menthol cigarette to non-menthol cigarette |
| BG001 | Control | Participants smoked their own menthol brand cigarette throughout the study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Smoking Topography- Puff Volume | The total puff volume for a single subject is the sum of puff volumes for a subject's cigarette smoked during the study session. The mean puff volume for the subjects will be used to examine the effect of cigarette menthol on smoking topography. The values provided are the average of subjects at study Day 5 (completion of baseline smoking own cigarettes), Day 20 and Day 35. | Those completing Study session 2 at Day 5. | Posted | Mean | Standard Error | mL | over 35 day study period |
|
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Because this was a cigarette brand switching study there was no systematic assessment tool.
Participants were asked about withdrawal symptoms due to the possibility of not smoking as many cigarettes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Control group: continued to smoke same, own brand cigarette. |
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Attrition rate over 35 day protocol of brand switching cigarette.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Strasser | University of Pennsylvania | 2157465788 | strasse3@mail.med.upenn.edu |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Control group smoked their own brand cigarette for entire duration of study.
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| Primary | Smoking Topography- Carbon Monoxide Boost | Carbon monoxide content in exhaled breath samples is measured before and after each cigarette smoked during study sessions. CO boost is the amount in parts per million that the subject's CO increases. | Posted | Mean | Standard Error | parts per million | Measured before and after each cigarette smoked at study sessions |
|
|
|
| Primary | Nicotine Levels | Urine nicotine levels will be measured to examine the effect of cigarette menthol on harm exposure measures. Participants provided samples on the final day of each period. NNK and 1-hop were not analyzed, total nicotine metabolites were assayed. | Those completing Day 5, returning sample for assay | Posted | Mean | Standard Error | micrograms/mL | 35 days |
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|
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| Primary | Subjective Rating of Cigarettes | Subjects completed a visual analog scale rating each cigarette smoked at each session. Subjects rated characteristics of the cigarette on a scale represented as a continuous horizontal line 10 cm long. Subjects drew an intersecting line to represent their rating. The rating reported is for the taste of the cigarette at the end of the period averaged across subjects in the group. A rating of 0 corresponds to Very Bad and a rating of 100 to Very Good for taste. There is no better or worse outcome for higher or lower ratings for taste. | Completed measure | Posted | Mean | Standard Error | units on a scale | Immediately after a cigarette smoked at the study session |
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| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Experimental | Menthol to non-menthol : Switch from smoking menthol to non-menthol cigarettes. | 0 | 45 | 0 | 15 |
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| Period 3 Own cigarette or CCrush non-menthol |
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| Period 3 Own cigarette or CCrush non-menthol |
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| Period 3 Own cigarette or CCrush non-menthol |
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