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| ID | Type | Description | Link |
|---|---|---|---|
| 1U54DA031659-01 | U.S. NIH Grant/Contract | View source | |
| U54DA031659-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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Project 2 will evaluate the impact of very low nicotine content cigarettes, e-cigarette nicotine content, and e-cigarette flavoring on cigarettes smoked per day, nicotine exposure, puff topography, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use, cardiovascular function, and perceived risk. Project 2 will also evaluate differences between conditions in compliance with product use and the ability to abstain from cigarette smoking when provided a financial incentive for abstinence from combusted tobacco. This is not a treatment program for smoking.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Nicotine Content (NNC) cigarette + moderate nicotine e-liquid + tobacco flavors | Experimental | Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors. |
|
| NNC cigarette + low nicotine e-liquid + tobacco flavors | Experimental | Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors. |
|
| NNC cigarette + moderate nicotine e-liquid + variety flavors | Experimental | Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors. |
|
| NNC cigarette + low nicotine e-liquid + variety flavors | Experimental | Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC Spectrum Cigarette | Other | Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Cigarettes Smoked Per Day | The average number of cigarettes (study and non-study, summed) smoked per day between the Week 10 and Week 12 visits (the end of the study). | Week 10 through Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of Cigarette Exposure Using Expired Carbon Monoxide (CO) | Measure of cigarette smoke exposure using data on expired breath CO. CO was captured using Covita Smokelyzer devices and standard exhalation procedures. The unit of measurement is parts per million (ppm). | Baseline - Week 12 |
| Number of Subjects With Smoke Free Days |
| Measure | Description | Time Frame |
|---|---|---|
| Minnesota Nicotine Withdrawal Scale | Measure of discomfort and dysfunction; 15-item self-reported scale to evaluate the effects of smoking cessation. Score ranges from 0 to 60 with higher score denoting more severe symptoms. | Baseline-Week 12 |
| Number of Days Using Assigned Vaping Device |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Donny, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Biotech Place | Winston-Salem | North Carolina | 27101 | United States | ||
| University of Pennsylvania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24964880 | Background | Agaku IT, King BA, Husten CG, Bunnell R, Ambrose BK, Hu SS, Holder-Hayes E, Day HR; Centers for Disease Control and Prevention (CDC). Tobacco product use among adults--United States, 2012-2013. MMWR Morb Mortal Wkly Rep. 2014 Jun 27;63(25):542-7. | |
| 25879896 | Background | Arrazola RA, Singh T, Corey CG, Husten CG, Neff LJ, Apelberg BJ, Bunnell RE, Choiniere CJ, King BA, Cox S, McAfee T, Caraballo RS; Centers for Disease Control and Prevention (CDC). Tobacco use among middle and high school students - United States, 2011-2014. MMWR Morb Mortal Wkly Rep. 2015 Apr 17;64(14):381-5. |
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Data will be available to other researchers, please contact the principal investigator for instructions.
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There were 106 screen failures.
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Nicotine Content (NNC) Cigarette + Moderate Nicotine E-liquid + Tobacco Flavors | Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors. NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks. Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline Through Week 12 |
|
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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 31, 2019 |
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|
| Very Low Nicotine Content (VLNC) cigarette + moderate nicotine e-liquid + tobacco flavor | Experimental | Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors. |
|
| VLNC cigarette + low nicotine e-liquid +tobacco flavors | Experimental | Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors. |
|
| VLNC cigarette + moderate nicotine e-liquid + variety flavors | Experimental | Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors. |
|
| VLNC cigarette + low nicotine e-liquid + variety flavors | Experimental | Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors |
|
| VLNC Spectrum Cigarette | Other | Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks |
|
| Moderate nicotine level e-liquid | Other | Participants are provided with moderate nicotine level e-liquid for 13 weeks |
|
| Low nicotine level e-liquid | Other | Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks |
|
| Tobacco Flavors | Other | Participants can choose e-liquid flavors from a selection of tobacco flavors |
|
| Tobacco and non-tobacco e-liquid flavors | Other | Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices |
|
Study team generates the smoke free days outcome by counting days where no cigarettes and no other forms of combusted tobacco products are used. Days where participants use no nicotine products and days where participants only vape are "smoke free." Percentage of smoke free days = the number days that participants reported smoking 0 cigarettes (0 study cigarettes and 0 non-study cigarettes) divided by the total number of days between their randomization and Week 12 visits. Due to the distribution of the data, statisticians grouped participants according to whether they had 0 smoke-free days or more than 0 smoke free days during the study. |
| Baseline-Week 12 |
collected through Interactive Voice Response (IVR) Review |
| Baseline-Week 12 |
| Cigarette Evaluation Scale | Assesses the extent to which the product they just sampled produced various subjective effects including satisfaction, good taste, dizziness, reduced appetite, nausea, and enjoyable sensations in the throat and chest. Score ranges from 1 to 91 with a higher score denoting more positive sensations. | Baseline-Week 12 |
| Mercapturic Acids | Measure of toxicant exposure | Baseline-Week 12 |
| Fagerstrom Nicotine Dependence Scale | Dependence Measure | Baseline-Week 12 |
| Study Cigarettes Smoked Per Day | Study cigarettes smoked per day | Baseline-Week 12 |
| IVR Review and Timeline Followback and E-liquid Accountability | Measure of vaping device use | Baseline-Week 12 |
| Number of Choices to Smoke in Preference Assessment Task | Measure of relative reinforcement | Week 00 |
| Purchase Task | Measure of relative reinforcement and substitution | Baseline, Week 12 |
| Predicted Behavior Questionnaire | Measure of hypothetical cigarette and vaping device use | Week 12 |
| IVR Review and Timeline Followback | Measure of compliance | Baseline-Week 12 |
| Drop-out Rate | Drop-out rate | Baseline-Week 12 |
| Urge to Use Questionnaire | Measure of discomfort and dysfunction | Baseline-Week 12 |
| Center for Epidemiologic Studies Depression Scale | Measure of discomfort and dysfunction | Baseline, Weeks 04, 08, 12 |
| Breath Alcohol | Alcohol use | Baseline - Week 12 |
| Urine Drug Screen | Drug use | Baseline, Week 12 |
| Alcohol Use Questionnaire | Alcohol use | Baseline-Week 12 |
| Drug Use Questionnaire | Drug use | Baseline-Week 12 |
| Weight | Weight | Baseline-Week 12 |
| Urinary Anatabine Biomarker | Measure of cigarette exposure and compliance | Baseline -Week 12 |
| Total Nicotine Equivalents | Measure of nicotine exposure | Baseline - Week 12 |
| Environmental and Social Influences on Tobacco Use Questionnaire | Measure of smoking and vaping context | Baseline-Week 12 |
| Context of Product Use Questionnaire | Measure of smoking and vaping context | Baseline-Week 12 |
| Puff Topography | Measure of smoking and vaping topography | Weeks 01 and 10 |
| Vaping Utility Questionnaire | Measure of product expectancy | Baseline, Week 12 |
| Smoking and Vaping Expectancy Questionnaires | Measure of product expectancy | Baseline-Week 12 |
| Cigarette and Product Evaluation Scale | Measure of product characteristics | Baseline-Week 12 |
| Perceived Health Risk Questionnaire | Measure of perceived personal health risk | Baseline-Week 12 |
| Penn State Smoking Dependence Questionnaire | Dependence Measure (smoking and vaping) | Baseline-Week 12 |
| Primary Subscales From Brief Wisconsin Inventory of Smoking Dependence Motive (WISDM) | Dependence Measure | Baseline-Week 12 |
| Population Assessment of Tobacco and Health (PATH) Smoking Dependence Questions | Dependence Measure (smoking and vaping) | Baseline-Week 12 |
| Stages of Change | Measure of intention to quit | Baseline-Week 12 |
| Contemplation Ladder | Measure of intention to quit | Baseline-Week 12 |
| Quit Attempts | Measure of intention to quit | Baseline-Week 12 |
| Post-intervention Changes in Tobacco Use Behavior | Measure of 30-day tobacco use post-intervention of study products | 30 Day Follow up |
| Qualitative Interview | Themes related to product use patterns, e-liquid flavor selection, non-compliance and general study feedback | 30 Day Follow up |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| 26321209 | Background | Baker H. E-cigarettes and subsequent tobacco use in adolescence. Lancet Oncol. 2015 Oct;16(13):e481. doi: 10.1016/S1470-2045(15)00272-7. Epub 2015 Aug 28. No abstract available. |
| 25555385 | Background | Bandiera FC, Ross KC, Taghavi S, Delucchi K, Tyndale RF, Benowitz NL. Nicotine Dependence, Nicotine Metabolism, and the Extent of Compensation in Response to Reduced Nicotine Content Cigarettes. Nicotine Tob Res. 2015 Sep;17(9):1167-72. doi: 10.1093/ntr/ntu337. Epub 2015 Jan 2. |
| 13688369 | Background | BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available. |
| 1935872 | Background | Biener L, Abrams DB. The Contemplation Ladder: validation of a measure of readiness to consider smoking cessation. Health Psychol. 1991;10(5):360-5. doi: 10.1037//0278-6133.10.5.360. |
| 14577978 | Background | Benowitz NL, Pomerleau OF, Pomerleau CS, Jacob P 3rd. Nicotine metabolite ratio as a predictor of cigarette consumption. Nicotine Tob Res. 2003 Oct;5(5):621-4. doi: 10.1080/1462220031000158717. |
| 7818638 | Background | Benowitz NL, Henningfield JE. Establishing a nicotine threshold for addiction. The implications for tobacco regulation. N Engl J Med. 1994 Jul 14;331(2):123-5. doi: 10.1056/NEJM199407143310212. No abstract available. |
| 19258480 | Background | Benowitz NL, Dains KM, Hall SM, Stewart S, Wilson M, Dempsey D, Jacob P 3rd. Progressive commercial cigarette yield reduction: biochemical exposure and behavioral assessment. Cancer Epidemiol Biomarkers Prev. 2009 Mar;18(3):876-83. doi: 10.1158/1055-9965.EPI-08-0731. Epub 2009 Mar 3. |
| 22354905 | Background | Benowitz NL, Dains KM, Hall SM, Stewart S, Wilson M, Dempsey D, Jacob P 3rd. Smoking behavior and exposure to tobacco toxicants during 6 months of smoking progressively reduced nicotine content cigarettes. Cancer Epidemiol Biomarkers Prev. 2012 May;21(5):761-9. doi: 10.1158/1055-9965.EPI-11-0644. Epub 2012 Feb 21. |
| 18006940 | Background | Benowitz NL, Hall SM, Stewart S, Wilson M, Dempsey D, Jacob P 3rd. Nicotine and carcinogen exposure with smoking of progressively reduced nicotine content cigarette. Cancer Epidemiol Biomarkers Prev. 2007 Nov;16(11):2479-85. doi: 10.1158/1055-9965.EPI-07-0393. |
| 26198394 | Background | Benowitz NL, Nardone N, Dains KM, Hall SM, Stewart S, Dempsey D, Jacob P 3rd. Effect of reducing the nicotine content of cigarettes on cigarette smoking behavior and tobacco smoke toxicant exposure: 2-year follow up. Addiction. 2015 Oct;110(10):1667-75. doi: 10.1111/add.12978. Epub 2015 Jul 21. |
| 19525207 | Background | Blank MD, Disharoon S, Eissenberg T. Comparison of methods for measurement of smoking behavior: mouthpiece-based computerized devices versus direct observation. Nicotine Tob Res. 2009 Jul;11(7):896-903. doi: 10.1093/ntr/ntp083. Epub 2009 Jun 11. |
| 8730526 | Background | Brauer LH, Hatsukami D, Hanson K, Shiffman S. Smoking topography in tobacco chippers and dependent smokers. Addict Behav. 1996 Mar-Apr;21(2):233-8. doi: 10.1016/0306-4603(95)00054-2. |
| 15784070 | Background | Buchhalter AR, Acosta MC, Evans SE, Breland AB, Eissenberg T. Tobacco abstinence symptom suppression: the role played by the smoking-related stimuli that are delivered by denicotinized cigarettes. Addiction. 2005 Apr;100(4):550-9. doi: 10.1111/j.1360-0443.2005.01030.x. |
| 7700960 | Background | Butschky MF, Bailey D, Henningfield JE, Pickworth WB. Smoking without nicotine delivery decreases withdrawal in 12-hour abstinent smokers. Pharmacol Biochem Behav. 1995 Jan;50(1):91-6. doi: 10.1016/0091-3057(94)00269-o. |
| 11796151 | Background | Caggiula AR, Donny EC, White AR, Chaudhri N, Booth S, Gharib MA, Hoffman A, Perkins KA, Sved AF. Cue dependency of nicotine self-administration and smoking. Pharmacol Biochem Behav. 2001 Dec;70(4):515-30. doi: 10.1016/s0091-3057(01)00676-1. |
| 12186222 | Background | Centers for Disease Control and Prevention (CDC). Cigarette smoking among adults--United States, 2000. MMWR Morb Mortal Wkly Rep. 2002 Jul 26;51(29):642-5. |
| 6668417 | Background | Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available. |
| Background | Congress (2009). Family Smoking Prevention and Tobacco Control Act. (H.R. 1256). U. S. Congress. Washington, D.C., U.S. Government Printing Office. |
| 11860387 | Background | Conklin CA, Tiffany ST. Applying extinction research and theory to cue-exposure addiction treatments. Addiction. 2002 Feb;97(2):155-67. doi: 10.1046/j.1360-0443.2002.00014.x. |
| 11260806 | Background | Cox LS, Tiffany ST, Christen AG. Evaluation of the brief questionnaire of smoking urges (QSU-brief) in laboratory and clinical settings. Nicotine Tob Res. 2001 Feb;3(1):7-16. doi: 10.1080/14622200020032051. |
| 23344557 | Background | Dawkins L, Turner J, Crowe E. Nicotine derived from the electronic cigarette improves time-based prospective memory in abstinent smokers. Psychopharmacology (Berl). 2013 Jun;227(3):377-84. doi: 10.1007/s00213-013-2983-2. Epub 2013 Jan 24. |
| 22503574 | Background | Dawkins L, Turner J, Hasna S, Soar K. The electronic-cigarette: effects on desire to smoke, withdrawal symptoms and cognition. Addict Behav. 2012 Aug;37(8):970-3. doi: 10.1016/j.addbeh.2012.03.004. Epub 2012 Mar 10. |
| 27192730 | Background | Food and Drug Administration, HHS. Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products. Final rule. Fed Regist. 2016 May 10;81(90):28973-9106. |
| 15229465 | Background | Dempsey D, Tutka P, Jacob P 3rd, Allen F, Schoedel K, Tyndale RF, Benowitz NL. Nicotine metabolite ratio as an index of cytochrome P450 2A6 metabolic activity. Clin Pharmacol Ther. 2004 Jul;76(1):64-72. doi: 10.1016/j.clpt.2004.02.011. |
| FG001 | NNC Cigarette + Low Nicotine E-liquid + Tobacco Flavors | Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors. NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks. Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors |
| FG002 | NNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors | Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors. NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks. Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices |
| FG003 | NNC Cigarette + Low Nicotine E-liquid + Variety Flavors | Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks. Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices |
| FG004 | Very Low Nicotine Content (VLNC) Cigarette + Moderate Nicotine E-liquid + Tobacco Flavor | Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors. VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors |
| FG005 | VLNC Cigarette + Low Nicotine E-liquid +Tobacco Flavors | Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors. VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors |
| FG006 | VLNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors | Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors. VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices |
| FG007 | VLNC Cigarette + Low Nicotine E-liquid + Variety Flavors | Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices |
| COMPLETED |
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| NOT COMPLETED |
|
| Week 12 Through Day 30 Follow up |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | NNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavors | Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors. NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks. Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors |
| BG001 | VLNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors | Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors. VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices |
| BG002 | VLNC Cigarette + Low Nicotine E-liquid +Tobacco Flavors | Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors. VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors |
| BG003 | VLNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavor | Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors. VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors |
| BG004 | NNC Cigarette + Low Nicotine E-liquid + Variety Flavors | Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks. Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices |
| BG005 | NNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors | Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors. NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks. Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices |
| BG006 | NNC Cigarette + Low Nicotine E-liquid + Tobacco Flavors | Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors. NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks. Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors |
| BG007 | VLNC Cigarette + Low Nicotine E-liquid + Variety Flavors | Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Total Cigarettes Smoked Per Day | The average number of cigarettes (study and non-study, summed) smoked per day between the Week 10 and Week 12 visits (the end of the study). | Posted | Mean | Standard Deviation | number of cigarettes | Week 10 through Week 12 |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Measure of Cigarette Exposure Using Expired Carbon Monoxide (CO) | Measure of cigarette smoke exposure using data on expired breath CO. CO was captured using Covita Smokelyzer devices and standard exhalation procedures. The unit of measurement is parts per million (ppm). | Posted | Mean | Standard Deviation | parts per million (ppm) | Baseline - Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Smoke Free Days | Study team generates the smoke free days outcome by counting days where no cigarettes and no other forms of combusted tobacco products are used. Days where participants use no nicotine products and days where participants only vape are "smoke free." Percentage of smoke free days = the number days that participants reported smoking 0 cigarettes (0 study cigarettes and 0 non-study cigarettes) divided by the total number of days between their randomization and Week 12 visits. Due to the distribution of the data, statisticians grouped participants according to whether they had 0 smoke-free days or more than 0 smoke free days during the study. | Posted | Number | participants | Baseline-Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Minnesota Nicotine Withdrawal Scale | Measure of discomfort and dysfunction; 15-item self-reported scale to evaluate the effects of smoking cessation. Score ranges from 0 to 60 with higher score denoting more severe symptoms. | Not Posted | Baseline-Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Days Using Assigned Vaping Device | collected through Interactive Voice Response (IVR) Review | Not Posted | Baseline-Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Cigarette Evaluation Scale | Assesses the extent to which the product they just sampled produced various subjective effects including satisfaction, good taste, dizziness, reduced appetite, nausea, and enjoyable sensations in the throat and chest. Score ranges from 1 to 91 with a higher score denoting more positive sensations. | Not Posted | Baseline-Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Mercapturic Acids | Measure of toxicant exposure | Not Posted | Baseline-Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Fagerstrom Nicotine Dependence Scale | Dependence Measure | Not Posted | Baseline-Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Study Cigarettes Smoked Per Day | Study cigarettes smoked per day | Not Posted | Baseline-Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | IVR Review and Timeline Followback and E-liquid Accountability | Measure of vaping device use | Not Posted | Baseline-Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Choices to Smoke in Preference Assessment Task | Measure of relative reinforcement | Not Posted | Week 00 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Purchase Task | Measure of relative reinforcement and substitution | Not Posted | Baseline, Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Predicted Behavior Questionnaire | Measure of hypothetical cigarette and vaping device use | Not Posted | Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | IVR Review and Timeline Followback | Measure of compliance | Not Posted | Baseline-Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Drop-out Rate | Drop-out rate | Not Posted | Baseline-Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Urge to Use Questionnaire | Measure of discomfort and dysfunction | Not Posted | Baseline-Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Center for Epidemiologic Studies Depression Scale | Measure of discomfort and dysfunction | Not Posted | Baseline, Weeks 04, 08, 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Breath Alcohol | Alcohol use | Not Posted | Baseline - Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Urine Drug Screen | Drug use | Not Posted | Baseline, Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Alcohol Use Questionnaire | Alcohol use | Not Posted | Baseline-Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Drug Use Questionnaire | Drug use | Not Posted | Baseline-Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Weight | Weight | Not Posted | Baseline-Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Urinary Anatabine Biomarker | Measure of cigarette exposure and compliance | Not Posted | Baseline -Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Total Nicotine Equivalents | Measure of nicotine exposure | Not Posted | Baseline - Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Environmental and Social Influences on Tobacco Use Questionnaire | Measure of smoking and vaping context | Not Posted | Baseline-Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Context of Product Use Questionnaire | Measure of smoking and vaping context | Not Posted | Baseline-Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Puff Topography | Measure of smoking and vaping topography | Not Posted | Weeks 01 and 10 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Vaping Utility Questionnaire | Measure of product expectancy | Not Posted | Baseline, Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Smoking and Vaping Expectancy Questionnaires | Measure of product expectancy | Not Posted | Baseline-Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Cigarette and Product Evaluation Scale | Measure of product characteristics | Not Posted | Baseline-Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Perceived Health Risk Questionnaire | Measure of perceived personal health risk | Not Posted | Baseline-Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Penn State Smoking Dependence Questionnaire | Dependence Measure (smoking and vaping) | Not Posted | Baseline-Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Primary Subscales From Brief Wisconsin Inventory of Smoking Dependence Motive (WISDM) | Dependence Measure | Not Posted | Baseline-Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Population Assessment of Tobacco and Health (PATH) Smoking Dependence Questions | Dependence Measure (smoking and vaping) | Not Posted | Baseline-Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Stages of Change | Measure of intention to quit | Not Posted | Baseline-Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Contemplation Ladder | Measure of intention to quit | Not Posted | Baseline-Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Quit Attempts | Measure of intention to quit | Not Posted | Baseline-Week 12 | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Post-intervention Changes in Tobacco Use Behavior | Measure of 30-day tobacco use post-intervention of study products | Not Posted | 30 Day Follow up | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Qualitative Interview | Themes related to product use patterns, e-liquid flavor selection, non-compliance and general study feedback | Not Posted | 30 Day Follow up | Participants |
Baseline through 12 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavors | Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors. NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks. Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors | 0 | 6 | 0 | 6 | 4 | 6 |
| EG001 | VLNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors | Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors. VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices | 0 | 7 | 0 | 7 | 6 | 7 |
| EG002 | VLNC Cigarette + Low Nicotine E-liquid +Tobacco Flavors | Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors. VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors | 0 | 6 | 0 | 6 | 6 | 6 |
| EG003 | VLNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavor | Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors. VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors | 0 | 6 | 0 | 6 | 6 | 6 |
| EG004 | NNC Cigarette + Low Nicotine E-liquid + Variety Flavors | Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks. Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices | 0 | 5 | 0 | 5 | 5 | 5 |
| EG005 | NNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors | Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors. NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks. Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices | 0 | 5 | 1 | 5 | 4 | 5 |
| EG006 | NNC Cigarette + Low Nicotine E-liquid + Tobacco Flavors | Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors. NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks. Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors | 0 | 10 | 1 | 10 | 10 | 10 |
| EG007 | VLNC Cigarette + Low Nicotine E-liquid + Variety Flavors | Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices | 0 | 5 | 0 | 5 | 4 | 5 |
| EG008 | Pre-Randomization | Participants signed consent but screen failed before randomizing into study | 0 | 106 | 0 | 106 | 14 | 106 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Infection | Infections and infestations | Systematic Assessment |
| ||
| anaphylaxis | Immune system disorders | Systematic Assessment |
| ||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymph Node, pain (swollen) | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Bradycardia (slow heart rate) | Cardiac disorders | Systematic Assessment |
| ||
| Ear Pain (ache/fullness) | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Tingling sensation left ear | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Dry Mouth | General disorders | Systematic Assessment |
| ||
| Tooth Ache | General disorders | Systematic Assessment |
| ||
| Dyspepsia (upset stomach) | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastroesophageal Reflux (GERD/heartburn/acid) | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Tooth decay | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Irritability (frustration) | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Allergic Reaction | Immune system disorders | Systematic Assessment |
| ||
| Oral Infection | Infections and infestations | Systematic Assessment |
| ||
| Sinusitis - sinus infection (incl. bacterial, fungal, viral) | Infections and infestations | Systematic Assessment |
| ||
| Skin infection | Infections and infestations | Systematic Assessment |
| ||
| Bacterial infection | Infections and infestations | Systematic Assessment |
| ||
| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Abrasion | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Sprained Ankle | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Appetite, Increase/hunger | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycemia (low blood sugar) | Endocrine disorders | Systematic Assessment |
| ||
| Myalgia (muscle aches/pain/spasms) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Arthralgia (joint aches) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Exposed Jaw Bone | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dizziness/Lightheadedness | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Headache (incl. migraine) | Vascular disorders | Systematic Assessment |
| ||
| Intracranial Vascular Event (stroke/aneurysm) | Vascular disorders | Systematic Assessment |
| ||
| Paresthesia (numbness/tingling) | Nervous system disorders | Systematic Assessment |
| ||
| Sinus Pain | General disorders | Systematic Assessment |
| ||
| Anxiety, clinical diagnosis | Psychiatric disorders | Systematic Assessment |
| ||
| Anxious (nervous) mood | Psychiatric disorders | Systematic Assessment |
| ||
| Anxiety/Panic Attack | Psychiatric disorders | Systematic Assessment |
| ||
| CES-D Score, elevated | Psychiatric disorders | Systematic Assessment |
| ||
| Depressed (sad) mood | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia (change/disturbance in sleep) | Psychiatric disorders | Systematic Assessment |
| ||
| Nightmare/terror | Psychiatric disorders | Systematic Assessment |
| ||
| Confusion | Psychiatric disorders | Systematic Assessment |
| ||
| Forgetfulness | Psychiatric disorders | Systematic Assessment |
| ||
| Worsened Kidney Disease | Renal and urinary disorders | Systematic Assessment |
| ||
| Allergic rhinitis (incl. seasonal allergies) | Immune system disorders | Systematic Assessment |
| ||
| Cough | General disorders | Systematic Assessment |
| ||
| Cough, Productive (lung 'fullness') | General disorders | Systematic Assessment |
| ||
| Nasal congestion (incl. runny nose) | General disorders | Systematic Assessment |
| ||
| Nosebleed / Dry nasal membrane | General disorders | Systematic Assessment |
| ||
| Postnasal Drip | Immune system disorders | Systematic Assessment |
| ||
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sore throat (incl. itchy/irritated throat) | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hyperhidrosis (excessive sweating) | General disorders | Systematic Assessment |
| ||
| Stress | Psychiatric disorders | Systematic Assessment |
| ||
| Hypertension (high BP) | Cardiac disorders | Systematic Assessment |
| ||
| methicillin-resistant Staphylococcus aureus | Infections and infestations | Systematic Assessment |
| ||
| vaginal infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
| ||
| Cut/Abrasion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| torn hamstring tendon | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| stiffness thumb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| elevated potassium (hyperkalemia) | Renal and urinary disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Donny, PhD | Wake Forest School of Medicine | 336-713-1520 | edonny@wakehealth.edu |
| Apr 14, 2021 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 14, 2020 | Apr 14, 2021 | ICF_002.pdf |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D062789 | Tobacco Products |
| ID | Term |
|---|---|
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
Not provided
Not provided
| Male |
|
| Prefer not to answer |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black |
|
| More than One Race |
|
| Other |
|
| Unknown/Prefer Not to Answer |
|
| OG002 | VLNC Cigarette + Low Nicotine E-liquid +Tobacco Flavors | Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors. VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors |
| OG003 | VLNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavor | Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors. VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors |
| OG004 | NNC Cigarette + Low Nicotine E-liquid + Variety Flavors | Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks. Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices |
| OG005 | NNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors | Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors. NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks. Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices |
| OG006 | NNC Cigarette + Low Nicotine E-liquid + Tobacco Flavors | Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors. NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks. Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors |
| OG007 | VLNC Cigarette + Low Nicotine E-liquid + Variety Flavors | Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices |
|
|
| OG002 | VLNC Cigarette + Low Nicotine E-liquid +Tobacco Flavors | Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors. VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors |
| OG003 | VLNC Cigarette + Moderate Nicotine E-liquid + Tobacco Flavor | Participants are provided with very low nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors. VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors |
| OG004 | NNC Cigarette + Low Nicotine E-liquid + Variety Flavors | Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low or nicotine-free nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks. Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices |
| OG005 | NNC Cigarette + Moderate Nicotine E-liquid + Variety Flavors | Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with moderate nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors. NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks. Moderate nicotine level e-liquid: Participants are provided with moderate nicotine level e-liquid for 13 weeks Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices |
| OG006 | NNC Cigarette + Low Nicotine E-liquid + Tobacco Flavors | Participants are provided with normal nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco e-liquid flavors. NNC Spectrum Cigarette: Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks. Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks Tobacco Flavors: Participants can choose e-liquid flavors from a selection of tobacco flavors |
| OG007 | VLNC Cigarette + Low Nicotine E-liquid + Variety Flavors | Participants are provided with very low or nicotine-free nicotine content tobacco Spectrum Cigarettes along with very low nicotine level e-liquid cartridges and can choose from tobacco and non-tobacco e-liquid flavors VLNC Spectrum Cigarette: Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks Low nicotine level e-liquid: Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks Tobacco and non-tobacco e-liquid flavors: Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices |
|
|