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| ID | Type | Description | Link |
|---|---|---|---|
| 1SC3GM122628 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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This study compares effects among Latino and African American cigarette smokers who use e-cigarettes with those who continue smoking as usual.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-Cigarette | Experimental | 6 weeks of JUUL electronic cigarettes |
|
| Assessment Only | Active Comparator | 6 weeks of smoking as usual |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-Cigarette Vs. Smoking as Usual | Other | 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual |
|
| Measure | Description | Time Frame |
|---|---|---|
| Toxicant Exposure | Urinary NNAL at week 6. Urinary NNAL measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Carbon Monoxide | Carbon monoxide at week 6. Breath test (PPM) | 6 weeks |
| Respiratory Symptoms | Respiratory symptoms at week 6. American Thoracic Society Questionnaire total score ranges from 0-32; higher scores reflect worse outcomes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim Pulvers, PhD, MPH | Associate Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California State University San Marcos | San Marcos | California | 92096 | United States | ||
| Swope Health Central |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35351805 | Derived | Nollen NL, Leavens ELS, Ahluwalia JS, Rice M, Mayo MS, Pulvers K. Menthol versus non-menthol flavouring and switching to e-cigarettes in black and Latinx adult menthol combustible cigarette smokers: secondary analyses from a randomised clinical trial. Tob Control. 2023 Nov;32(6):786-789. doi: 10.1136/tobaccocontrol-2021-057180. Epub 2022 Mar 29. | |
| 34530834 | Derived | Pulvers K, Rice M, Ahluwalia JS, Arnold MJ, Marez C, Nollen NL. "It is the One Thing that has Worked": facilitators and barriers to switching to nicotine salt pod system e-cigarettes among African American and Latinx people who smoke: a content analysis. Harm Reduct J. 2021 Sep 16;18(1):98. doi: 10.1186/s12954-021-00543-y. |
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| ID | Title | Description |
|---|---|---|
| FG000 | E-Cigarette | 6 weeks of JUUL electronic cigarettes E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual |
| FG001 | Assessment Only | 6 weeks of smoking as usual E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
One post-randomization exclusion from analyses due to not meeting race/ethnicity inclusion criteria
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| ID | Title | Description |
|---|---|---|
| BG000 | E-Cigarette | 6 weeks of JUUL electronic cigarettes E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual |
| BG001 | Assessment Only | 6 weeks of smoking as usual E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual |
| 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 | Toxicant Exposure | Urinary NNAL at week 6. Urinary NNAL measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS) | Of the 115 participants enrolled in the treatment group, one was excluded post-randomization due to not meeting race/ethnicity inclusion criteria. Total number analyzed in treatment group was 114. | Posted | Median | Inter-Quartile Range | pg/ml | 6 weeks |
|
6 weeks
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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 | E-Cigarette | 6 weeks of JUUL electronic cigarettes E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Mouth/Throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kim Pulvers | California State University San Marcos | 760 750 4127 | kpulvers@csusm.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 23, 2018 | Aug 2, 2021 | Prot_000.pdf |
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| 6 weeks |
| Lung Function | FEF 25%-75%, L/s at week 6 measured by spirometer | 6 weeks |
| Systolic Blood Pressure | Systolic blood pressure at week 6 | 6 weeks |
| Diastolic Blood Pressure | Diastolic blood pressure at week 6 | 6 weeks |
| Tobacco Dependence | Tobacco dependence at week 6. Validated questions from PATH; total score ranges from 15-76, higher scores reflect worse outcomes | 6 weeks |
| Self-efficacy to Resist Smoking | Self-efficacy to resist smoking at week 6. Brief Self Efficacy to Resist Smoking Cigarettes Scale; total score ranges from 0-60, higher score reflects better outcome | 6 weeks |
| Kansas City |
| Missouri |
| 64130 |
| United States |
| 33837422 | Derived | Arnold MJ, Nollen NL, Mayo MS, Ahluwalia JS, Leavens EL, Zhang G, Rice M, Pulvers K. Harm Reduction Associated with Dual Use of Cigarettes and e-Cigarettes in Black and Latino Smokers: Secondary Analyses from a Randomized Controlled e-Cigarette Switching Trial. Nicotine Tob Res. 2021 Oct 7;23(11):1972-1976. doi: 10.1093/ntr/ntab069. |
| 33206193 | Derived | Pulvers K, Nollen NL, Rice M, Schmid CH, Qu K, Benowitz NL, Ahluwalia JS. Effect of Pod e-Cigarettes vs Cigarettes on Carcinogen Exposure Among African American and Latinx Smokers: A Randomized Clinical Trial. JAMA Netw Open. 2020 Nov 2;3(11):e2026324. doi: 10.1001/jamanetworkopen.2020.26324. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| High school education or less | Count of Participants | Participants |
|
| 200% federal poverty level or lower | Count of Participants | Participants |
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| Never married | Count of Participants | Participants |
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| Menthol smoker | Count of Participants | Participants |
|
| Duration smoking in years | Mean | Standard Deviation | years |
|
| Time to first cigarette 30 minutes or less | Participants were asked how soon after waking they typically smoked first cigarette of the day. Response options included within 30 minutes of waking or after 30 minutes of waking. | Count of Participants | Participants |
|
| Days smoked in past 7 days | Mean | Standard Deviation | days |
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| Cigarettes per day in past 7 days | Mean | Standard Deviation | cigarettes per day |
|
| Days used e-cigarettes in past 7 days | Mean | Standard Deviation | days |
|
| E-cigarette uses in past 7 days | Mean | Standard Deviation | uses per day |
|
| History of chronic obstructive pulmonary disorder | Count of Participants | Participants |
|
| History of asthma | Count of Participants | Participants |
|
| History of mental health diagnosis | Count of Participants | Participants |
|
| History of substance abuse | Count of Participants | Participants |
|
| Urine cotinine, ng/mL | Median | Inter-Quartile Range | ng/mL |
|
| Urine NNAL, pg/mL | Median | Inter-Quartile Range | pg/mL |
|
| Carbon monoxide, ppm | Median | Inter-Quartile Range | ppm |
|
| Lung function, FEF 25%-75%, L/s | Median | Inter-Quartile Range | L/s |
|
| Respiratory symptoms, number | American Thoracic Society Questionnaire total score ranges from 0-32; higher scores reflect worse outcomes | Median | Inter-Quartile Range | units on a scale |
|
| Systolic blood pressure | Median | Inter-Quartile Range | mm Hg |
|
| Diastolic blood pressure | Median | Inter-Quartile Range | mm Hg |
|
|
|
| Secondary | Carbon Monoxide | Carbon monoxide at week 6. Breath test (PPM) | Of the 115 participants enrolled in the treatment group, one was excluded post-randomization due to not meeting race/ethnicity inclusion criteria. Total number analyzed in treatment group was 114. | Posted | Median | Inter-Quartile Range | ppm | 6 weeks |
|
|
|
| Secondary | Respiratory Symptoms | Respiratory symptoms at week 6. American Thoracic Society Questionnaire total score ranges from 0-32; higher scores reflect worse outcomes | Of the 115 participants enrolled in the treatment group, one was excluded post-randomization due to not meeting race/ethnicity inclusion criteria. Total number analyzed in treatment group was 114. | Posted | Median | Inter-Quartile Range | score on a scale | 6 weeks |
|
|
|
| Secondary | Lung Function | FEF 25%-75%, L/s at week 6 measured by spirometer | Of the 115 participants enrolled in the treatment group, one was excluded post-randomization due to not meeting race/ethnicity inclusion criteria. Total number analyzed in treatment group was 114. | Posted | Median | Inter-Quartile Range | L/sec | 6 weeks |
|
|
|
| Secondary | Systolic Blood Pressure | Systolic blood pressure at week 6 | Of the 115 participants enrolled in the treatment group, one was excluded post-randomization due to not meeting race/ethnicity inclusion criteria. Total number analyzed in treatment group was 114. | Posted | Median | Inter-Quartile Range | mmHg | 6 weeks |
|
|
|
| Secondary | Diastolic Blood Pressure | Diastolic blood pressure at week 6 | Of the 115 participants enrolled in the treatment group, one was excluded post-randomization due to not meeting race/ethnicity inclusion criteria. Total number analyzed in treatment group was 114. | Posted | Median | Inter-Quartile Range | mmHg | 6 weeks |
|
|
|
| Secondary | Tobacco Dependence | Tobacco dependence at week 6. Validated questions from PATH; total score ranges from 15-76, higher scores reflect worse outcomes | Of the 115 participants enrolled in the treatment group, one was excluded post-randomization due to not meeting race/ethnicity inclusion criteria. Total number analyzed in treatment group was 114. | Posted | Median | Inter-Quartile Range | score on a scale | 6 weeks |
|
|
|
| Secondary | Self-efficacy to Resist Smoking | Self-efficacy to resist smoking at week 6. Brief Self Efficacy to Resist Smoking Cigarettes Scale; total score ranges from 0-60, higher score reflects better outcome | Of the 115 participants enrolled in the treatment group, one was excluded post-randomization due to not meeting race/ethnicity inclusion criteria. Total number analyzed in treatment group was 114. | Posted | Median | Inter-Quartile Range | score on a scale | 6 weeks |
|
|
|
| 0 |
| 114 |
| 0 |
| 114 |
| 46 |
| 114 |
| EG001 | Assessment Only | 6 weeks of smoking as usual E-Cigarette Vs. Smoking as Usual: 6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual | 0 | 54 | 0 | 54 | 22 | 54 |
| Irritated Mouth/Throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nauseau and/or Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Rapid Heart Rate | Cardiac disorders | Systematic Assessment |
|
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