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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA154992 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This nationwide telephone and mail- based research study will recruit 1,400 cigarette smokers who are not motivated to quit to test the effects of a marketed oral, non-combustible smokeless tobacco product on cigarette smoking behaviors. It will also track the participants' usage patterns of the smokeless tobacco product.
Half of the participants will receive a new, potentially safer tobacco product during the first six weeks of the study, and half will not. During this six-week period, each participant will complete three brief phone interviews. After this first six week period, participants will complete 6 other brief follow-up interviews, where they will answer questionnaires about their smoking habits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PREP (Potentially Reduced Exposure Product) Group | Experimental |
| |
| cigarette group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product | Drug | The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her. |
| Measure | Description | Time Frame |
|---|---|---|
| Quit Attempts and Abstinence | % of study participants making a quit attempt or staying abstinent from smoking during the study Notes: Floating abstinence: Any 7-day period of non-smoking, ever within study. PPA: point-prevalence abstinence | From study enrollment through end of one-year follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew J. Carpenter, Ph.D. | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27071730 | Derived | Carpenter MJ, Wahlquist AE, Burris JL, Gray KM, Garrett-Mayer E, Cummings KM, Alberg AJ. Snus undermines quit attempts but not abstinence: a randomised clinical trial among US smokers. Tob Control. 2017 Mar;26(2):202-209. doi: 10.1136/tobaccocontrol-2015-052783. Epub 2016 Apr 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PREP (Potentially Reduced Exposure Product) Group | Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her. |
| FG001 | Cigarette Group | This group will smoke their normal cigarettes as much or as little as they want to. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PREP (Potentially Reduced Exposure Product) Group | Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Quit Attempts and Abstinence | % of study participants making a quit attempt or staying abstinent from smoking during the study Notes: Floating abstinence: Any 7-day period of non-smoking, ever within study. PPA: point-prevalence abstinence | Posted | Number | percentage of participants | From study enrollment through end of one-year follow up |
|
Adverse events were asked to both groups at all 8 follow-up interviews (weeks 3, 6, 10, 14, 18, 32, 46, and 58). Numbers below are cumulative of all adverse events reported at all 8 follow-up interviews.
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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 | PREP (Potentially Reduced Exposure Product) Group | Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Matthew J. Carpenter | Medical University of South Carolina | 843-876-2436 | carpente@musc.edu |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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|
| BG001 | Cigarette Group | This group will smoke their normal cigarettes as much or as little as they want to. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Intend to quit smoking, next month | 0 - 10 scale, where 0 is no intent to quit and 10 is the most intent to quit smoking in the next 30 days | Mean | Standard Deviation | units on a scale |
|
| Confidence to quit smoking | 0 -10 scale, where 0 is no confidence to quit smoking and 10 is the most confidence to quit smoking, in the next 30 days | Mean | Standard Deviation | units on a scale |
|
| Cigarettes per day | Mean | Standard Deviation | average cigarettes per day at baseline |
|
| OG001 | Cigarette Group | This group will smoke their normal cigarettes as much or as little as they want to. |
|
|
| 3 |
| 626 |
| 458 |
| 626 |
| EG001 | Cigarette Group | This group will smoke their normal cigarettes as much or as little as they want to. | 3 | 610 | 414 | 610 |
| headache | General disorders | Systematic Assessment |
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| heartburn | Gastrointestinal disorders | Systematic Assessment |
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| mouth soreness | Gastrointestinal disorders | Systematic Assessment |
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| dizziness or lightheadnedness | General disorders | Systematic Assessment |
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| dry mouth | General disorders | Systematic Assessment |
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| sore jaw | General disorders | Systematic Assessment |
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| excessive salivation | General disorders | Systematic Assessment |
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| insomnia | General disorders | Systematic Assessment |
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| hiccups | Gastrointestinal disorders | Systematic Assessment |
|
| burning in throat/mouth | Gastrointestinal disorders | Systematic Assessment |
|
| other | General disorders | Systematic Assessment |
|
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