Project 2 Cigarette and E-cigarette Nicotine Content and E-liquid Flavors
NCT ID: NCT03185546
Last Updated: 2021-05-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
156 participants
INTERVENTIONAL
2018-08-06
2020-03-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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
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
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
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
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
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
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
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
Interventions
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NNC Spectrum Cigarette
Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
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
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
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
Eligibility Criteria
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Inclusion Criteria
* Generally good health.
Exclusion Criteria
* Planning to quit smoking.
18 Years
ALL
Yes
Sponsors
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University of Pennsylvania
OTHER
National Institute on Drug Abuse (NIDA)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Eric Donny, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest Biotech Place
Winston-Salem, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Congress (2009). Family Smoking Prevention and Tobacco Control Act. (H.R. 1256). U. S. Congress. Washington, D.C., U.S. Government Printing Office.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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