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| ID | Type | Description | Link |
|---|---|---|---|
| 5U19CA157345 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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Cigarette smokers who are eligible will enter a Camel Snus sampling phase. Smokers interested in continuing with the study after the sampling phase will undergo a 2 week baseline assessment phase and will then be randomized to one of the three experimental conditions for 8 weeks. Tobacco use patterns, subjective responses to product, and nicotine and toxicant exposure will be assessed.
Baseline smoking period: Subjects will be required to attend 2 baseline clinic visits where baseline assessments will be captured including a record of their cigarette or other tobacco intake on a daily basis using an interactive voice response system (IVR).
Experimental Period: After the baseline assessment, subjects will be randomized to one of five experimental conditions: 1) smoking usual brand cigarette controls, who after 8-weeks will be offered Camel Snus to use as they will for 8 more weeks; 2) complete substitution (i.e., no smoking) and use snus instead ; 3) partial substitution - use of both snus and cigarettes as you like. Snus, but not cigarettes, will be provided to subjects at the clinic visits. Subjects will attend clinic visits over the next 8 weeks where tobacco use patterns and biomarker data will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Brand Cigarette | Experimental | Smoking usual brand cigarette controls, who after 8-weeks will be offered Camel Snus and instructed for partial or complete substitution of cigarettes (subject's choice); |
|
| Complete Substitution | Experimental | Use snus in place of cigarettes |
|
| Partial Substitution (Snus and Cigarettes) | Experimental | Use snus and cigarettes how ever you like |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cigarettes | Other | Smoke their usual brand of cigarettes and follow their normal patterns of use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Smoke-free Days | Number of days subjects smoked no cigarettes during the intervention was compared between groups. | 8 weeks (56 (+/-5) days) |
| Measure | Description | Time Frame |
|---|---|---|
| CEMA (2-cyanoethylmercapturic Acid) | 2-cyanoethylmercapturic acid (CEMA) is a biomarker for exposure to acrylonitrile, a volatile organic compound, and is sensitive to changes in cigarette smoke exposure. | 8 weeks |
| Total Nicotine Exposure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dorothy Hatsukami, M.D. | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota | 55455 | United States | ||
| Roswell Park Cancer Center |
After 1 week, participants returned to the clinic with snus tins and unused snus pouches. Tobacco use over the past week was assessed and participants completed self-report questionnaires. Participants who used at least seven snus pouches (based on potential use of one pouch per day) and continued to smoke were eligible to enter the clinical trial. These criteria were withheld from participants to ensure an unbiased willingness to use snus.
Smokers were recruited from Minneapolis, Minnesota; Columbus and Coshocton, Ohio, and Buffalo, New York between May 2013 and August 2016. Internet and local media advertisements read: "Smokers who want to try a new oral tobacco product are needed for a research study that may reduce their exposure to harmful tobacco smoke."
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| ID | Title | Description |
|---|---|---|
| FG000 | Complete Substitution | Use snus in place of cigarettes Snus: Winterchill or Robust flavors |
| FG001 | Partial Substitution (Snus and Cigarettes) | Use snus and cigarettes how ever you like Cigarettes: Smoke their usual brand of cigarettes and follow their normal patterns of use. Snus: Winterchill or Robust flavors |
| FG002 | Usual Brand Cigarette | Smoking usual brand cigarette controls, who after 8-weeks will be offered Camel Snus and instructed for partial or complete substitution of cigarettes (subject's choice); Cigarettes: Smoke their usual brand of cigarettes and follow their normal patterns of use. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Complete Substitution | Use snus in place of cigarettes Snus: Winterchill or Robust flavors |
| BG001 | Partial Substitution (Snus and Cigarettes) | Use snus and cigarettes how ever you like Cigarettes: Smoke their usual brand of cigarettes and follow their normal patterns of use. Snus: Winterchill or Robust flavors |
| 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 | Smoke-free Days | Number of days subjects smoked no cigarettes during the intervention was compared between groups. | Posted | Median | Full Range | days | 8 weeks (56 (+/-5) days) |
|
Adverse events related to study product reported over 8 weeks of snus product use.
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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 | Complete Substitution | Substitute snus in place of all cigarettes Snus: Winterchill or Robust flavors |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Injury, poisoning and procedural complications | Systematic Assessment | Auto accident unrelated to study product |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hearburn/reflux | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dorothy Hatsukami, PhD | University of Minnesota | 612-626-2121 | hatsu001@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 17, 2013 | May 4, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 15, 2013 | May 4, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D062789 | Tobacco Products |
| D014030 | Tobacco, Smokeless |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| Snus | Other | Winterchill or Robust flavors |
|
|
Urinary total nicotine equivalents, the molar sum of nicotine and six metabolites, accounts for more than 90% of a nicotine dose
| 8 weeks |
| Urinary Total NNAL | Urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides (total NNAL) is a metabolite of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), one of the group of chemicals termed tobacco-specific N-nitrosamines (TSNA) | 8 weeks |
| Buffalo |
| New York |
| 14263 |
| United States |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| BG002 | Usual Brand Cigarette | Smoking usual brand cigarette controls, who after 8-weeks will be offered Camel Snus and instructed for partial or complete substitution of cigarettes (subject's choice); Cigarettes: Smoke their usual brand of cigarettes and follow their normal patterns of use. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Mean cigarettes per day (CPD) | Mean | Full Range | Cigarettes Per Day |
|
| Fagerstrom Test for Nicotine Dependence (FTND) | The FTND is a self-report measure of nicotine dependency. Scores range from 0-8 with higher scores indicating more dependency. | Mean | Full Range | units on a scale |
|
| Total Nicotine Equivalents (TNE) | Median | Full Range | nmol/mg |
|
Smoking usual brand cigarette controls, who after 8-weeks will be offered Camel Snus and instructed for partial or complete substitution of cigarettes (subject's choice); Cigarettes: Smoke their usual brand of cigarettes and follow their normal patterns of use. |
|
|
| Secondary | CEMA (2-cyanoethylmercapturic Acid) | 2-cyanoethylmercapturic acid (CEMA) is a biomarker for exposure to acrylonitrile, a volatile organic compound, and is sensitive to changes in cigarette smoke exposure. | Posted | Geometric Mean | 95% Confidence Interval | pmol/mg per creatinine | 8 weeks |
|
|
|
| Secondary | Total Nicotine Exposure | Urinary total nicotine equivalents, the molar sum of nicotine and six metabolites, accounts for more than 90% of a nicotine dose | Posted | Geometric Mean | 95% Confidence Interval | nmol/mg | 8 weeks |
|
|
|
| Secondary | Urinary Total NNAL | Urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides (total NNAL) is a metabolite of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), one of the group of chemicals termed tobacco-specific N-nitrosamines (TSNA) | Posted | Geometric Mean | 95% Confidence Interval | pmol/mg creatinine | 8 weeks |
|
|
|
| 0 |
| 64 |
| 1 |
| 64 |
| 5 |
| 64 |
| EG001 | Partial Substitution (Snus and Cigarettes) | Substitute snus for cigarettes ad libitum Cigarettes: Smoke their usual brand of cigarettes and follow their normal patterns of use. Snus: Winterchill or Robust flavors | 0 | 60 | 0 | 60 | 1 | 60 |
| EG002 | Usual Brand Cigarette | Smoking usual brand cigarette controls Cigarettes: Smoke their usual brand of cigarettes and follow their normal patterns of use. | 0 | 26 | 0 | 26 | 0 | 26 |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Gum sensitivity | Gastrointestinal disorders | Systematic Assessment |
|
| Irritability | Psychiatric disorders | Systematic Assessment |
|
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