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| ID | Type | Description | Link |
|---|---|---|---|
| U19CA157345 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The main focus of this study is to determine the use of nicotine-containing products across the three experimental conditions. Subjects will be monitored to determine their continued use of assigned cigarettes, switching to other combusted and/or non-combusted tobacco, or cessation of all tobacco containing products.
This is a single site, single-blind, randomized trial with three experimental conditions tested for a period of 8 weeks: 1) Very low nicotine content (VLNC) cigarettes (0.07 nicotine yield) with access to combusted (except cigarettes) and non-combusted tobacco and medicinal nicotine products; 2) VLNC cigarettes with access to only non-combusted tobacco and medicinal nicotine products; and 3) conventional nicotine (CN) content experimental cigarettes (0.8 mg nicotine) with access to combusted and non-combusted products. This study will examine the use of nicotine-containing products across the three experimental conditions. Subjects will be monitored to determine their continued use of assigned cigarettes, switching to other combusted (e.g., little cigars, large cigars, pipes) and/or non-combusted tobacco products (e.g., conventional smokeless tobacco, snus for smokers, dissolvables, e-cigarettes, medicinal nicotine), or cessation of all tobacco containing products. Toxicant exposure across the three conditions will also be examined.
Eligible subjects will be provided very low nicotine content cigarettes and are told to use the product ad lib for 8 weeks. Subjects will complete questionnaires on demographics, smoking and health history, drug and alcohol use history, mood and perceptions of the study tobacco product. Biomarker samples will be analyzed for exposure levels of nicotine and tobacco-related toxicants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CN + combusted & non-combusted products | Experimental | Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time. |
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| VLNC + combusted & non-combusted products | Experimental | Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time. |
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| VLNC with non-combusted products | Experimental | Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VLNC cigarettes | Other | Modified risk tobacco product |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Days Using Alternative Products | The primary aim of the study is to determine the rate of use of alternative nicotine-containing products across the three experimental conditions. | 8 week intervetnion period |
| Number of Combusted Products Smoked | Number of combusted products smoked per day during the last two weeks of the intervention period. | At weeks 6-8 (last two weeks of intervention period) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of 24 Hour Quit Attempts | Rate of 24 hour quit attempts during the intervention period | 8 week intervention period |
| Carcinogen Exposure Biomarker: Total NNAL | Total NNAL (pmol/mg creatinine) is a measure of carcinogen exposure assessed at the end of intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dorothy K Hatsukami, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Tobacco Research Program | Minneapolis | Minnesota | 55414 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27614097 | Background | Hatsukami DK, Luo X, Dick L, Kangkum M, Allen SS, Murphy SE, Hecht SS, Shields PG, al'Absi M. Reduced nicotine content cigarettes and use of alternative nicotine products: exploratory trial. Addiction. 2017 Jan;112(1):156-167. doi: 10.1111/add.13603. Epub 2016 Nov 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CN + Combusted & Non-combusted Products | Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time. Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, . Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine. CN cigarettes: Experimental cigarettes with conventional nicotine content. |
| FG001 | VLNC + Combusted & Non-combusted Products | Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time. VLNC cigarettes: Modified risk tobacco product Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, . Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine. |
| FG002 | VLNC With Non-combusted Products | Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products. VLNC cigarettes: Modified risk tobacco product Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CN + Combusted & Non-combusted Products | Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time. Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, . Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine. CN cigarettes: Experimental cigarettes with conventional nicotine content. |
| 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 | Number of Days Using Alternative Products | The primary aim of the study is to determine the rate of use of alternative nicotine-containing products across the three experimental conditions. | Posted | Mean | Standard Deviation | Number of days | 8 week intervetnion period |
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During the 8 week intervention
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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 | CN + Combusted & Non-combusted Products | Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time. Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, . Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine. CN cigarettes: Experimental cigarettes with conventional nicotine content. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Pneumonia |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
Exploratory study due to small number of participants. Only used first generation of electronic cigarette products.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dorothy Hatsukami | University of Minnesota | 612 626-2121 | hatsu001@umn.edu |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| Combusted Products | Other | Options for combusted tobacco products include cigars, cigarillos, and little cigars, . |
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| Non-combusted products | Other | Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine. |
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| CN cigarettes | Other | Experimental cigarettes with conventional nicotine content. |
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| Week 8 (end of intervention) |
| Physician Decision |
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| BG001 | VLNC + Combusted & Non-combusted Products | Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time. VLNC cigarettes: Modified risk tobacco product Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, . Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine. |
| BG002 | VLNC With Non-combusted Products | Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products. VLNC cigarettes: Modified risk tobacco product Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine. |
| BG003 | 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 | Count of Participants | Participants |
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| OG001 | VLNC + Combusted & Non-combusted Products | Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time. VLNC cigarettes: Modified risk tobacco product Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, . Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine. |
| OG002 | VLNC With Non-combusted Products | Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products. VLNC cigarettes: Modified risk tobacco product Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine. |
|
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| Primary | Number of Combusted Products Smoked | Number of combusted products smoked per day during the last two weeks of the intervention period. | Posted | Mean | Standard Deviation | combuster products per day | At weeks 6-8 (last two weeks of intervention period) |
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| Secondary | Rate of 24 Hour Quit Attempts | Rate of 24 hour quit attempts during the intervention period | Posted | Count of Participants | Participants | 8 week intervention period |
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| Secondary | Carcinogen Exposure Biomarker: Total NNAL | Total NNAL (pmol/mg creatinine) is a measure of carcinogen exposure assessed at the end of intervention. | Posted | Mean | 95% Confidence Interval | pmol//mg creatinine | Week 8 (end of intervention) |
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| 0 |
| 27 |
| 6 |
| 27 |
| EG001 | VLNC + Combusted & Non-combusted Products | Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time. VLNC cigarettes: Modified risk tobacco product Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, . Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine. | 0 | 53 | 7 | 53 |
| EG002 | VLNC With Non-combusted Products | Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products. VLNC cigarettes: Modified risk tobacco product Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine. | 1 | 56 | 23 | 56 |
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| Headache | General disorders | Non-systematic Assessment |
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| Irritability | General disorders | Non-systematic Assessment |
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| nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Sore throat | General disorders | Non-systematic Assessment |
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| Difficulty concentrating | General disorders | Non-systematic Assessment |
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