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Smoking remains a leading cause of preventable disease and premature death worldwide. Approximately 1 out of every 5 deaths is associated with cigarette smoking, and roughly half of all daily smokers will die prematurely from tobacco-related illness. Reducing the nicotine in cigarettes to the point that they are rendered non-addictive can potentially be an effective public policy measure that can significantly reduce tobacco-related mortality and morbidity by decreasing the initiation of smoking and promoting cessation. The Family Smoking Prevention and Tobacco Control Act (FSPTCA) enables the FDA to establish tobacco product standards including placing limits on the allowable nicotine content of cigarettes. Currently, no reduced nicotine cigarettes are available that will allow studying the feasibility of this policy measure. The National Institute on Drug Abuse has contracted with Research Triangle Institute to assist in the development of cigarettes with varying nicotine content that can be made available to researchers. They have established a contract that will result in the manufacture of 9 million cigarettes to be distributed to the research community. Prior to full production, the palatability and nicotine intake of these cigarettes in smokers must be determined.
Phase 3: This descriptive study will use a between subjects, double blind design. This study will test 3 nicotine levels of nicotine, tar and ventilation. Subjects and research assistants will be blind to the cigarette type.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 Low Level Nicotine Cigarette | Experimental | (0.4 mg/g) |
|
| Arm 2 Intermediate Nicotine Level Cigarette | Experimental | (5.7-5.8 mg/g) |
|
| Arm 3 High Level Nicotine Cigarette | Experimental | (11.4-12.8 mg/g) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low level nicotine cigarette | Other | smoke the study cigarette exclusively for one week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in UrineTotal Nicotine Equivalent (TNE) Between Baseline and Week 1 | Two urine TNE levels are taken, one at baseline and one at week 1, to assess TNE levels for nicotine exposure. TNE is the sum of nicotine, cotinine, trans 3'-hydroxycotinine and their respective glucuronide conjugates. Values reported in nmols/ml. | Second Visit (Week 1) minus Baseline (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Responses on Modified Cigarette Evaluation Scale | Modified Cigarette Evaluation Scale [CES] is a 100 mm visual analog scale (0=not at all or very little nicotine; 100=extremely or high in nicotine) of 20 questions assessing different dimensions of responses to usual brand cigarettes (e.g., psychological reward, satisfaction and aversiveness) and includes additional 5 point likert-type questions (definitely agree to definitely disagree) on perceptions of satisfaction and willingness to use the product. Results satisfaction subscale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dorothy Hatsukami, Ph.D. | Tobacco Use Research Program, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55414 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23178320 | Result | Hatsukami DK, Heishman SJ, Vogel RI, Denlinger RL, Roper-Batker AN, Mackowick KM, Jensen J, Murphy SE, Thomas BF, Donny E. Dose-response effects of spectrum research cigarettes. Nicotine Tob Res. 2013 Jun;15(6):1113-21. doi: 10.1093/ntr/nts247. Epub 2012 Nov 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 Low Level Nicotine Cigarette | Low level nicotine cigarette: smoke the study cigarette exclusively for one week |
| FG001 | Arm 2 Intermediate Nicotine Level Cigarette | Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week |
| FG002 | Arm 3 High Level Nicotine Cigarette | High level nicotine cigarette: smoke the study cigarette exclusively for one week |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Daily cigarette smokers
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 Low Level Nicotine Cigarette | Low level nicotine cigarette (0.400 mg/g; menthol 0.405 mg/g): smoke the study cigarette exclusively for one week |
| BG001 | Arm 2 Intermediate Nicotine Level Cigarette |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change in UrineTotal Nicotine Equivalent (TNE) Between Baseline and Week 1 | Two urine TNE levels are taken, one at baseline and one at week 1, to assess TNE levels for nicotine exposure. TNE is the sum of nicotine, cotinine, trans 3'-hydroxycotinine and their respective glucuronide conjugates. Values reported in nmols/ml. | Posted | Mean | Standard Error | nmols/ml | Second Visit (Week 1) minus Baseline (Day 1) |
|
1 week
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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 | Arm 1 Low Level Nicotine Cigarette | Low level nicotine cigarette: smoke the study cigarette exclusively for one week |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dorohty Hatsukami, Ph.D. | University of Minnesota Tobacco Research Programs | 612-626-2121 | hatsu001@umn.edu |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Intermediate nicotine level cigarette | Other | smoke the study cigarette exclusively for one week |
|
| High level nicotine cigarette | Other | smoke the study cigarette exclusively for one week |
|
| Baseline usual brand cigarettes (Day 1) compared to when using study cigarettes (Week 1) |
| Change From Baseline of Perceived Health Risk Scale Response to Test Cigarettes | Questionnaire: Perceived Health Risk Scale asks subjects to rate their perception of health risks for lung cancer for the study product to which they have been randomly assigned. This is a 100 mm visual analog scale; 0=very low risk of disease, 100=very high risk of disease. | Baseline (Day 1) Compared to Second Visit (Week 1) |
| Comparison of Number of Cigarettes Smoked | Subjects were given a daily diary to collect the number of study and/or conventional cigarettes they have smoked each day. Cigarettes smoked (both usual brand and experimental) in a given week were summed over the first 7 reported days. If the number of cigarettes smoked was missing for 1 day, the average of the other days in that week was used in its place and reported as total number of cigarettes per week. | 1 week |
Intermediate nicotine level cigarette (5.86 mg/g menthol 5.87 mg/g): smoke the study cigarette exclusively for one week
| BG002 | Arm 3 High Level Nicotine Cigarette | High level nicotine cigarette (10.4 mg/g; menthol: 12.3): smoke the study cigarette exclusively for one week |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Menthol | Number | participants |
|
| Cigarettes per day | Mean | Standard Deviation | Cigarettes per day |
|
| OG002 | Arm 3 High Level Nicotine Cigarette | High level nicotine cigarette: smoke the study cigarette exclusively for one week |
|
|
| Secondary | Responses on Modified Cigarette Evaluation Scale | Modified Cigarette Evaluation Scale [CES] is a 100 mm visual analog scale (0=not at all or very little nicotine; 100=extremely or high in nicotine) of 20 questions assessing different dimensions of responses to usual brand cigarettes (e.g., psychological reward, satisfaction and aversiveness) and includes additional 5 point likert-type questions (definitely agree to definitely disagree) on perceptions of satisfaction and willingness to use the product. Results satisfaction subscale. | Posted | Mean | Standard Error | units on a scale | Baseline usual brand cigarettes (Day 1) compared to when using study cigarettes (Week 1) |
|
|
|
| Secondary | Change From Baseline of Perceived Health Risk Scale Response to Test Cigarettes | Questionnaire: Perceived Health Risk Scale asks subjects to rate their perception of health risks for lung cancer for the study product to which they have been randomly assigned. This is a 100 mm visual analog scale; 0=very low risk of disease, 100=very high risk of disease. | Posted | Mean | Standard Error | units on a scale | Baseline (Day 1) Compared to Second Visit (Week 1) |
|
|
|
| Secondary | Comparison of Number of Cigarettes Smoked | Subjects were given a daily diary to collect the number of study and/or conventional cigarettes they have smoked each day. Cigarettes smoked (both usual brand and experimental) in a given week were summed over the first 7 reported days. If the number of cigarettes smoked was missing for 1 day, the average of the other days in that week was used in its place and reported as total number of cigarettes per week. | Posted | Mean | Standard Deviation | cigarettes per week | 1 week |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Arm 2 Intermediate Nicotine Level Cigarette | Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week | 0 | 11 | 0 | 11 |
| EG002 | Arm 3 High Level Nicotine Cigarette | High level nicotine cigarette: smoke the study cigarette exclusively for one week | 0 | 12 | 0 | 12 |
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