A Study of Unfiltered Cigarettes Among Committed Smokers
NCT ID: NCT03749876
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
37 participants
INTERVENTIONAL
2019-01-17
2020-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cigarette Filter Study
NCT07348679
Investigate the Exposure to Selected Smoke Constituents in Smokers Switching to Distillation Based Smoking Article
NCT00812279
Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors
NCT02000921
Feasibility Study - Filter Ventilation
NCT04514471
A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco
NCT01509586
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Aim 1. Determine smokers' satisfaction, and attitudes towards smoking cigarettes if they were to switch from smoking filtered to unfiltered cigarettes. The investigators hypothesize that smokers who smoke unfiltered cigarettes will have less satisfaction with their smoking compared with smoking filtered cigarettes.
Aim 2. Measure changes in smoking topography and cigarettes smoked per day among smokers who change to unfiltered cigarettes for two weeks compared with these measures while smoking filtered cigarettes. The investigators hypothesize that smokers who smoke unfiltered cigarettes for two weeks will change their topography such that they will inhale less deeply and frequently and will smoke fewer cigarettes per day.
Aim 3. Measure changes in urinary cotinine, NNAL, and VOC excretion among smokers who smoke unfiltered cigarettes for two weeks compared to smoking filtered cigarettes.
The investigators hypothesize that smokers who smoke unfiltered cigarettes for two weeks will have lower urinary cotinine, NNAL, and VOC excretion compared with filtered cigarettes.
The results from this trial can inform a larger clinical trial that can be submitted to the National Institutes of Health/Food and Drug Administration to develop evidence on the potentially positive impact of removing plastic filters from commercial cigarettes. It will allow us to develop sound scientific methods to assess the topography of smoking and excretion of cotinine, tobacco-specific nitrosamines, and VOCs by smokers who smoke cigarettes with and without filters. This new knowledge may lead the Food and Drug Administration or specific states to consider banning the sale of filtered cigarettes because filters make it easier for young people to start smoking, unjustifiably discourage smokers from quitting, and contaminate the environment with non-biodegradable, toxic waste.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Study Group 1
Study Group 1 will begin the first treatment period with the provided Unfiltered Cigarettes intervention for two weeks, followed by a three-week wash-out period, before switching to the provided Filtered Cigarette intervention for two weeks.
Unfiltered Cigarettes
Participants will be given unfiltered Pall Mall or Camel cigarettes to smoke for two weeks according to the brand they smoked prior to the start of the study. They will agree to smoke the cigarettes using a monitoring device (CReSS) that measures puffing behavior on five (5) days during each of the two weeks. They will also collect their cigarette butts on all days as a measure of smoking behaviors.
Filtered Cigarettes
Participants will be given filtered Pall Mall or Camel cigarettes to smoke for two weeks according to the brand they smoked prior to the start of the study. They will agree to smoke the cigarettes using a monitoring device (CReSS) that measures puffing behavior on five (5) days during each of the two weeks. They will also collect their cigarette butts on all days as a measure of smoking behaviors.
Study Group 2
Study Group 2 will begin the first treatment period with the provided Filtered Cigarettes intervention for two weeks, followed by a three-week wash-out period, before switching to the provided Unfiltered Cigarette intervention for two weeks.
Unfiltered Cigarettes
Participants will be given unfiltered Pall Mall or Camel cigarettes to smoke for two weeks according to the brand they smoked prior to the start of the study. They will agree to smoke the cigarettes using a monitoring device (CReSS) that measures puffing behavior on five (5) days during each of the two weeks. They will also collect their cigarette butts on all days as a measure of smoking behaviors.
Filtered Cigarettes
Participants will be given filtered Pall Mall or Camel cigarettes to smoke for two weeks according to the brand they smoked prior to the start of the study. They will agree to smoke the cigarettes using a monitoring device (CReSS) that measures puffing behavior on five (5) days during each of the two weeks. They will also collect their cigarette butts on all days as a measure of smoking behaviors.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Unfiltered Cigarettes
Participants will be given unfiltered Pall Mall or Camel cigarettes to smoke for two weeks according to the brand they smoked prior to the start of the study. They will agree to smoke the cigarettes using a monitoring device (CReSS) that measures puffing behavior on five (5) days during each of the two weeks. They will also collect their cigarette butts on all days as a measure of smoking behaviors.
Filtered Cigarettes
Participants will be given filtered Pall Mall or Camel cigarettes to smoke for two weeks according to the brand they smoked prior to the start of the study. They will agree to smoke the cigarettes using a monitoring device (CReSS) that measures puffing behavior on five (5) days during each of the two weeks. They will also collect their cigarette butts on all days as a measure of smoking behaviors.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Able to provide informed consent, and
* Are ages 21 to 65, and
* Smoke at least 25 days per month, and
* Smoke at least 5 cigarettes per day on the days they smoke, and
* Have been smoking cigarettes for at least 1 year, and
* Have smoked exclusively Camel or Pall Mall cigarettes over the past two weeks, or are willing to do so for the two weeks prior to, and for seven weeks during, the study, and
* Are fluent in English, and
* Have regular access to a telephone, and
* Have smoked only filtered cigarettes for the past year, and
* Have access to transportation to California State University, San Marcos (CSUSM), and
* Report primary (≥50% of the time) smoking of cigarettes, allowing for secondary use of other tobacco products, and
* Agree to the terms of the trial
* Self-report uncontrolled diabetes (i.e., diagnosed with diabetes, and it is not being managed by a physician), or
* Present to the enrollment visit with a systolic blood pressure greater than 160 mm Hg or a diastolic blood pressure greater than 105 mm Hg, or
* Self-report involvement in another clinical trial, or
* Self-report hospitalization for psychiatric issues or had a heart-related event (e.g. heart attack) at enrollment or within the past 30 days, or
* Self-report attempts to quit or cut down on smoking in past 30 days, or
* Self-report use of pharmacotherapy to aid smoking cessation within the past 30 days, or
* Are breastfeeding, pregnant, or may become pregnant during the next six months, or
* Are planning to move out of San Diego in the next 9 weeks, or
* Do not meet expected expired carbon monoxide (CO) measurements of smokers (Expired CO measurements\>10 parts per million (ppm) will confirm status as a current smoker of at \>5 cigarettes/day on the initial visit), or
* Are deemed mentally unstable (i.e., psychotic, under influence of drugs or alcohol, or unable to comprehend the call or meeting) or physically unfit (i.e, physically unwell) to participate in the study based on the researcher's determination at the enrollment visit
21 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
California State University, San Marcos
OTHER
Tobacco Related Disease Research Program
OTHER
San Diego State University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Eyal Oren
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Eyal Oren, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
San Diego State University School of Public Health
Kimberly Pulvers, Ph.D.
Role: STUDY_DIRECTOR
California State University, San Marcos
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
California State University San Marcos
San Marcos, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hastrup JL, Cummings KM, Swedrock T, Hyland A, Pauly JL. Consumers' knowledge and beliefs about the safety of cigarette filters. Tob Control. 2001 Mar;10(1):84. doi: 10.1136/tc.10.1.84. No abstract available.
Ito H, Matsuo K, Tanaka H, Koestler DC, Ombao H, Fulton J, Shibata A, Fujita M, Sugiyama H, Soda M, Sobue T, Mor V. Nonfilter and filter cigarette consumption and the incidence of lung cancer by histological type in Japan and the United States: analysis of 30-year data from population-based cancer registries. Int J Cancer. 2011 Apr 15;128(8):1918-28. doi: 10.1002/ijc.25531.
Brooks DR, Austin JH, Heelan RT, Ginsberg MS, Shin V, Olson SH, Muscat JE, Stellman SD. Influence of type of cigarette on peripheral versus central lung cancer. Cancer Epidemiol Biomarkers Prev. 2005 Mar;14(3):576-81. doi: 10.1158/1055-9965.EPI-04-0468.
Song MA, Benowitz NL, Berman M, Brasky TM, Cummings KM, Hatsukami DK, Marian C, O'Connor R, Rees VW, Woroszylo C, Shields PG. Cigarette Filter Ventilation and its Relationship to Increasing Rates of Lung Adenocarcinoma. J Natl Cancer Inst. 2017 Dec 1;109(12):djx075. doi: 10.1093/jnci/djx075.
Novotny TE, Slaughter E. Tobacco Product Waste: An Environmental Approach to Reduce Tobacco Consumption. Curr Environ Health Rep. 2014 May 6;1(3):208-216. doi: 10.1007/s40572-014-0016-x. eCollection 2014.
Slaughter E, Gersberg RM, Watanabe K, Rudolph J, Stransky C, Novotny TE. Toxicity of cigarette butts, and their chemical components, to marine and freshwater fish. Tob Control. 2011 May;20 Suppl 1(Suppl_1):i25-9. doi: 10.1136/tc.2010.040170.
Thun MJ, Carter BD, Feskanich D, Freedman ND, Prentice R, Lopez AD, Hartge P, Gapstur SM. 50-year trends in smoking-related mortality in the United States. N Engl J Med. 2013 Jan 24;368(4):351-64. doi: 10.1056/NEJMsa1211127.
Connolly GN, Alpert HR. Has the tobacco industry evaded the FDA's ban on 'Light' cigarette descriptors? Tob Control. 2014 Mar;23(2):140-5. doi: 10.1136/tobaccocontrol-2012-050746. Epub 2013 Mar 13.
Harris B. The intractable cigarette 'filter problem'. Tob Control. 2011 May;20 Suppl 1(Suppl_1):i10-6. doi: 10.1136/tc.2010.040113.
Czoli CD, Hammond D. Cigarette packaging: Youth perceptions of "natural" cigarettes, filter references, and contraband tobacco. J Adolesc Health. 2014 Jan;54(1):33-9. doi: 10.1016/j.jadohealth.2013.07.016. Epub 2013 Sep 4.
Samet JM, Aladadyan L. Should the FDA Ban Cigarette Filter Ventilation? J Natl Cancer Inst. 2017 Dec 1;109(12):djx073. doi: 10.1093/jnci/djx073. No abstract available.
Djordjevic MV, Stellman SD, Zang E. Doses of nicotine and lung carcinogens delivered to cigarette smokers. J Natl Cancer Inst. 2000 Jan 19;92(2):106-11. doi: 10.1093/jnci/92.2.106.
Pauly JL, Mepani AB, Lesses JD, Cummings KM, Streck RJ. Cigarettes with defective filters marketed for 40 years: what Philip Morris never told smokers. Tob Control. 2002 Mar;11 Suppl 1(Suppl 1):I51-61. doi: 10.1136/tc.11.suppl_1.i51.
Novotny TE, Hardin SN, Hovda LR, Novotny DJ, McLean MK, Khan S. Tobacco and cigarette butt consumption in humans and animals. Tob Control. 2011 May;20 Suppl 1(Suppl_1):i17-20. doi: 10.1136/tc.2011.043489.
Oren E, Bell ML, Garcia F, Perez-Velez C, Gerald LB. Promoting adherence to treatment for latent TB infection through mobile phone text messaging: study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2017 Mar 13;3:15. doi: 10.1186/s40814-017-0128-9. eCollection 2017.
Horne DJ, Campo M, Ortiz JR, Oren E, Arentz M, Crothers K, Narita M. Association between smoking and latent tuberculosis in the U.S. population: an analysis of the National Health and Nutrition Examination Survey. PLoS One. 2012;7(11):e49050. doi: 10.1371/journal.pone.0049050. Epub 2012 Nov 8.
Oren E, Rothers J, Stern DA, Morgan WJ, Halonen M, Wright AL. Cough during infancy and subsequent childhood asthma. Clin Exp Allergy. 2015 Sep;45(9):1439-46. doi: 10.1111/cea.12573.
Matt GE, Quintana PJE, Zakarian JM, Hoh E, Hovell MF, Mahabee-Gittens M, Watanabe K, Datuin K, Vue C, Chatfield DA. When smokers quit: exposure to nicotine and carcinogens persists from thirdhand smoke pollution. Tob Control. 2016 Sep;26(5):548-556. doi: 10.1136/tobaccocontrol-2016-053119. Epub 2016 Sep 21.
Matt GE, Quintana PJE, Hoh E, Zakarian JM, Chowdhury Z, Hovell MF, Jacob P, Watanabe K, Theweny TS, Flores V, Nguyen A, Dhaliwal N, Hayward G. A Casino goes smoke free: a longitudinal study of secondhand and thirdhand smoke pollution and exposure. Tob Control. 2018 Nov;27(6):643-649. doi: 10.1136/tobaccocontrol-2017-054052. Epub 2018 Feb 8.
Matt GE, Quintana PJ, Fortmann AL, Zakarian JM, Galaviz VE, Chatfield DA, Hoh E, Hovell MF, Winston C. Thirdhand smoke and exposure in California hotels: non-smoking rooms fail to protect non-smoking hotel guests from tobacco smoke exposure. Tob Control. 2014 May;23(3):264-72. doi: 10.1136/tobaccocontrol-2012-050824. Epub 2013 May 13.
Pulvers K, Hood A, Limas EF, Thomas MD. Female smokers show lower pain tolerance in a physical distress task. Addict Behav. 2012 Oct;37(10):1167-70. doi: 10.1016/j.addbeh.2012.05.002. Epub 2012 May 22.
Pulvers K, Emami AS, Nollen NL, Romero DR, Strong DR, Benowitz NL, Ahluwalia JS. Tobacco Consumption and Toxicant Exposure of Cigarette Smokers Using Electronic Cigarettes. Nicotine Tob Res. 2018 Jan 5;20(2):206-214. doi: 10.1093/ntr/ntw333.
Morabia A, Bernstein MS, Curtin F, Berode M. Validation of self-reported smoking status by simultaneous measurement of carbon monoxide and salivary thiocyanate. Prev Med. 2001 Jan;32(1):82-8. doi: 10.1006/pmed.2000.0779.
Ripoll J, Girauta H, Ramos M, Medina-Bombardo D, Pastor A, Alvarez-Ossorio C, Gorreto L, Esteva M, Garcia E, Urendez A, Buades A, Torres E. Clinical trial on the efficacy of exhaled carbon monoxide measurement in smoking cessation in primary health care. BMC Public Health. 2012 Jul 4;12:322. doi: 10.1186/1471-2458-12-322.
Javors MA, Hatch JP, Lamb RJ. Cut-off levels for breath carbon monoxide as a marker for cigarette smoking. Addiction. 2005 Feb;100(2):159-67. doi: 10.1111/j.1360-0443.2004.00957.x.
Zhu SH, Pulvers K, Zhuang Y, Baezconde-Garbanati L. Most Latino smokers in California are low-frequency smokers. Addiction. 2007 Oct;102 Suppl 2:104-11. doi: 10.1111/j.1360-0443.2007.01961.x.
Rahmanian SD, Diaz PT, Wewers ME. Tobacco use and cessation among women: research and treatment-related issues. J Womens Health (Larchmt). 2011 Mar;20(3):349-57. doi: 10.1089/jwh.2010.2173.
Cubbin C, Soobader MJ, LeClere FB. The intersection of gender and race/ethnicity in smoking behaviors among menthol and non-menthol smokers in the United States. Addiction. 2010 Dec;105 Suppl 1:32-8. doi: 10.1111/j.1360-0443.2010.03191.x.
Weinberger AH, McKee SA. Mood and smoking behavior: the role of expectancy accessibility and gender. Addict Behav. 2012 Dec;37(12):1349-52. doi: 10.1016/j.addbeh.2012.07.010. Epub 2012 Jul 28.
Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.
Hammond D, Fong GT, Cummings KM, O'Connor RJ, Giovino GA, McNeill A. Cigarette yields and human exposure: a comparison of alternative testing regimens. Cancer Epidemiol Biomarkers Prev. 2006 Aug;15(8):1495-501. doi: 10.1158/1055-9965.EPI-06-0047.
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.
Gust SW, Pickens RW. Does cigarette nicotine yield affect puff volume? Clin Pharmacol Ther. 1982 Oct;32(4):418-22. doi: 10.1038/clpt.1982.182. No abstract available.
Zacny JP, Stitzer ML. Effects of smoke deprivation interval on puff topography. Clin Pharmacol Ther. 1985 Jul;38(1):109-15. doi: 10.1038/clpt.1985.143.
Lee EM, Malson JL, Waters AJ, Moolchan ET, Pickworth WB. Smoking topography: reliability and validity in dependent smokers. Nicotine Tob Res. 2003 Oct;5(5):673-9. doi: 10.1080/1462220031000158645.
Blank MD, Breland AB, Enlow PT, Duncan C, Metzger A, Cobb CO. Measurement of smoking behavior: Comparison of self-reports, returned cigarette butts, and toxicant levels. Exp Clin Psychopharmacol. 2016 Oct;24(5):348-355. doi: 10.1037/pha0000083. Epub 2016 Jun 27.
Clark PI, Gautam SP, Hlaing WM, Gerson LW. Response error in self-reported current smoking frequency by black and white established smokers. Ann Epidemiol. 1996 Nov;6(6):483-9. doi: 10.1016/s1047-2797(96)00049-x.
Wye P, Gow LB, Constable J, Bowman J, Lawn S, Wiggers J. Observation of the extent of smoking in a mental health inpatient facility with a smoke-free policy. BMC Psychiatry. 2014 Mar 29;14:94. doi: 10.1186/1471-244X-14-94.
Goniewicz ML, Havel CM, Peng MW, Jacob P 3rd, Dempsey D, Yu L, Zielinska-Danch W, Koszowski B, Czogala J, Sobczak A, Benowitz NL. Elimination kinetics of the tobacco-specific biomarker and lung carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol. Cancer Epidemiol Biomarkers Prev. 2009 Dec;18(12):3421-5. doi: 10.1158/1055-9965.EPI-09-0874.
Jacob P 3rd, Havel C, Lee DH, Yu L, Eisner MD, Benowitz NL. Subpicogram per milliliter determination of the tobacco-specific carcinogen metabolite 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol in human urine using liquid chromatography-tandem mass spectrometry. Anal Chem. 2008 Nov 1;80(21):8115-21. doi: 10.1021/ac8009005. Epub 2008 Oct 8.
Jain RB. Levels of selected urinary metabolites of volatile organic compounds among children aged 6-11 years. Environ Res. 2015 Oct;142:461-70. doi: 10.1016/j.envres.2015.07.023. Epub 2015 Aug 7.
Goniewicz ML, Gawron M, Smith DM, Peng M, Jacob P 3rd, Benowitz NL. Exposure to Nicotine and Selected Toxicants in Cigarette Smokers Who Switched to Electronic Cigarettes: A Longitudinal Within-Subjects Observational Study. Nicotine Tob Res. 2017 Feb;19(2):160-167. doi: 10.1093/ntr/ntw160. Epub 2016 Aug 17.
Dodder NG, Tai SS, Sniegoski LT, Zhang NF, Welch MJ. Certification of creatinine in a human serum reference material by GC-MS and LC-MS. Clin Chem. 2007 Sep;53(9):1694-9. doi: 10.1373/clinchem.2007.090027. Epub 2007 Jul 27.
Tonstad S, Gustavsson G, Kruse E, Walmsley JM, Westin A. Symptoms of nicotine toxicity in subjects achieving high cotinine levels during nicotine replacement therapy. Nicotine Tob Res. 2014 Sep;16(9):1266-71. doi: 10.1093/ntr/ntu076. Epub 2014 May 22.
Jacob P 3rd, Yu L, Duan M, Ramos L, Yturralde O, Benowitz NL. Determination of the nicotine metabolites cotinine and trans-3'-hydroxycotinine in biologic fluids of smokers and non-smokers using liquid chromatography-tandem mass spectrometry: biomarkers for tobacco smoke exposure and for phenotyping cytochrome P450 2A6 activity. J Chromatogr B Analyt Technol Biomed Life Sci. 2011 Feb 1;879(3-4):267-76. doi: 10.1016/j.jchromb.2010.12.012. Epub 2010 Dec 21.
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, 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.
Pulvers K, Tracy L, Novotny TE, Satybaldiyeva N, Hunn A, Romero DR, Dodder NG, Magraner J, Oren E. Switching people who smoke to unfiltered cigarettes: perceptions, addiction and behavioural effects in a cross-over randomised controlled trial. Tob Control. 2023 Jul;32(4):520-523. doi: 10.1136/tobaccocontrol-2021-056815. Epub 2021 Nov 19.
Oren E, Pulvers K, Romero DR, Barber C, Carter E, Tracy LA, Novotny TE. Effects of Unfiltered Cigarettes on Smoking Behavior and Toxicant Exposure: Protocol for a Randomized Crossover Clinical Trial. JMIR Res Protoc. 2020 Dec 8;9(12):e19603. doi: 10.2196/19603.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TRDRP Award #580582
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.