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| ID | Type | Description | Link |
|---|---|---|---|
| P01CA217806-S2 | Other Grant/Funding Number | NCI Trial ID | |
| P01CA217806 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Ohio State University | OTHER |
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The goals of this project are to determine the effects of varying degrees of cigarette filter ventilation on biomarkers of toxicant exposure and smoking behavior and on subjective responses to the cigarette.
The primary aim of this study is to examine the effects of unventilated vs ventilated filter cigarettes on urinary biomarkers of toxicant exposure and smoking behavior (e.g., cigarettes per day, intensity of smoking). The secondary objectives are 1) to examine the effects of cigarette filter ventilation on subjective measures such as cigarette dependence and responses to study cigarettes.
This randomized controlled multi-site study will assess the effect of cigarettes with unventilated vs. ventilated filters on smoking behavior and biomarkers of tobacco toxicant exposure. The study, using telehealth and brief visits, will also examine the feasibility of remote collection of multiple biological samples.
Subjects (N=164; N=82 in each group) will be randomly assigned to: 1) Ventilated cigarettes; or 2) Unventilated cigarettes. Smokers will undergo an in person screening and then a 9 week experimental trial; 1 week of usual brand cigarettes; 2 weeks of ventilated study cigarettes and 6 weeks on either the ventilated or unventilated study cigarettes.
Subjective measures, alveolar carbon monoxide, blood pressure and cigarettes per day will be collected remotely. Biological samples collected at home will be dropped off at the clinic where the study cigarettes will be dispensed.
Biomarker samples will be assessed for total nicotine equivalents, tobacco specific nitrosamines and volatile organic compound.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ventilated Cigarette Filter | Experimental | Filters with approximately 24-32% filter ventilation |
|
| Unventilated Cigarette Filter | Experimental | Filters with approximately 0-5.0% filter ventilation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ventilated Cigarette Filter | Other | Ventilated Cigarette Filter |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total NNAL: 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol [ng/g Creatinine] | Absolute change from baseline level of total NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) at the week 6 visit (ng/g creatinine) measured in urine using liquid chromatography-tandem mass spectrometry (LC-MS/MS). | 6 weeks randomized intervention |
| Change in Cigarettes Per Day (CPD) | Change in cigarettes per day, daily diary reviewed data. | 7 days prior to week 0 visit and 7 days prior to week 6 visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dorothy K Hatsukami, Ph.D | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Tobacco Research Program | Minneapolis | Minnesota | 55414 | United States | ||
| Ohio State University Comprehensive Cancer Center |
Intend to share findings from this research through publications and presentations. Institutions and individuals wishing to access any resources or data must contact the Principal Investigator (Hatsukami). Data will be available in two formats. One will be a summary of the data, with graphs and tables, posted as pdf files and as raw individual-level data for analysis. Data generated by this grant will be made to outside investigators, according to NIH Guidance. When data are shared, there will be no limits placed on how the data will be used. Users will agree, however, that the recipient must not transfer the data to other users and that the data are only to be used for research purposes. A record of transfer of data and a copy of the dataset that was distributed will be kept by University of Minnesota.
Data will not be available until primary and secondary papers are accepted for publication
Persons requesting data must do so in writing, identifying their affiliation and how the data will be used. Upon review, access will be determined.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ventilated Cigarette Filter | Filters with approximately 24-32% filter ventilation Ventilated Cigarette Filter: Ventilated Cigarette Filter |
| FG001 | Unventilated Cigarette Filter | Filters with approximately 0-5.0% filter ventilation Unventilated Cigarette Filter: Unventilated Cigarette Filter |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ventilated Cigarette Filter | Filters with approximately 24-32% filter ventilation Ventilated Cigarette Filter: Ventilated Cigarette Filter |
| BG001 | Unventilated Cigarette Filter |
| 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 Total NNAL: 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol [ng/g Creatinine] | Absolute change from baseline level of total NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) at the week 6 visit (ng/g creatinine) measured in urine using liquid chromatography-tandem mass spectrometry (LC-MS/MS). | Posted | Median | Inter-Quartile Range | ng/g creatinine | 6 weeks randomized intervention |
|
6 months
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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 | Ventilated Cigarette Filter | Filters with approximately 24-32% filter ventilation Ventilated Cigarette Filter: Ventilated Cigarette Filter |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Superficial blood clot in lower leg | Vascular disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasal congestion (incl. runny nose) | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dorothy Hatsukami | Masonic Cancer Center | 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 | Dec 8, 2022 | May 6, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 5, 2021 | Mar 28, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
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Phase III randomized, single blind, multi-center study assessing the impact of filter ventilation
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Single blind
| Unventilated Cigarette Filter |
| Other |
Unventilated Cigarette Filter |
|
| Columbus |
| Ohio |
| 43210 |
| United States |
| Physician Decision |
|
Filters with approximately 0-5.0% filter ventilation
Unventilated Cigarette Filter: Unventilated Cigarette Filter
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
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| Primary | Change in Cigarettes Per Day (CPD) | Change in cigarettes per day, daily diary reviewed data. | Posted | Mean | Standard Deviation | Cigarettes per day | 7 days prior to week 0 visit and 7 days prior to week 6 visit |
|
|
|
| 0 |
| 80 |
| 1 |
| 80 |
| 73 |
| 80 |
| EG001 | Unventilated Cigarette Filter | Filters with approximately 0-5.0% filter ventilation Unventilated Cigarette Filter: Unventilated Cigarette Filter | 0 | 84 | 0 | 84 | 74 | 84 |
| Headache (incl. migraine) | Nervous system disorders | CTCAE | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Sore/itchy/irritated throat | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | CTCAE | Non-systematic Assessment |
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| Fatigue | General disorders | CTCAE | Non-systematic Assessment |
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| Myalgia (muscle aches/pain/spasms) | Musculoskeletal and connective tissue disorders | CTCAE | Non-systematic Assessment |
|
| Cough, Productive (lung 'fullness') | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
|
| Allergic rhinitis (incl. seasonal allergies) | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
| Depressed (sad) mood | Psychiatric disorders | CTCAE | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
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| Hypertension / Elevated BP | Vascular disorders | CTCAE | Non-systematic Assessment |
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| Pain (other) | General disorders | CTCAE | Non-systematic Assessment |
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| Anxious (nervous) mood | Psychiatric disorders | CTCAE | Non-systematic Assessment |
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| Fever | General disorders | CTCAE | Non-systematic Assessment |
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| Ear Pain (ache/fullness) | Ear and labyrinth disorders | CTCAE | Non-systematic Assessment |
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| Chills | General disorders | CTCAE | Non-systematic Assessment |
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| Infections and Infestations - Other, Specify | Infections and infestations | CTCAE | Non-systematic Assessment |
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| Tachycardia / Fast heart rate | Cardiac disorders | CTCAE | Non-systematic Assessment |
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| Oral dysesthesia (burning/tingling/numbness/pain) | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
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| Sinus Pain | Nervous system disorders | CTCAE | Non-systematic Assessment |
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| Surgical and medical procedures, Other, Specify | Surgical and medical procedures | CTCAE | Non-systematic Assessment |
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| Dysgeusia (change in taste/smell) | Nervous system disorders | CTCAE | Non-systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE | Non-systematic Assessment |
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| Influenza (PCP dx; cough/lung sx separately) | Infections and infestations | CTCAE | Non-systematic Assessment |
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| Bruising | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
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| Sinusitis - sinus infection (incl. bacterial, fungal, viral) | Infections and infestations | CTCAE | Non-systematic Assessment |
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| Neuralgia / Neuropathy (nerve pain) | Nervous system disorders | CTCAE | Non-systematic Assessment |
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| Stomach Pain | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
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| Investigations - Other abnormal lab, low blood oxygen | Investigations | CTCAE | Non-systematic Assessment |
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| Gastroesophageal Reflux (GERD/heartburn/acid) | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | CTCAE | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | CTCAE | Non-systematic Assessment |
|
| Hypotension / Low BP | Vascular disorders | CTCAE | Non-systematic Assessment |
|
| Sprained joint | Injury, poisoning and procedural complications | CTCAE | Non-systematic Assessment |
|
| Phlegm, increase in | Respiratory, thoracic and mediastinal disorders | CTCAE | Non-systematic Assessment |
|
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