Cigarette SmokingNCT03749876
A Study of Unfiltered Cigarettes Among Committed Smokers
A study testing Unfiltered Cigarettes and Filtered Cigarettes in people with Cigarette Smoking and Tobacco Smoking, run by San Diego State University at 1 site in United States.
Trial summary
This study is an open-label, randomized, 9-week, two-sequence, two-treatment, cross-over clinical trial of 40 adult filtered cigarette smokers who switch to unfiltered cigarettes There will be a 1-week baseline period, 2 weeks of smoking filtered or unfiltered cigarettes (determined at time of randomization), and a… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking, Tobacco Smoking
- What is being tested?
- Unfiltered Cigarettes and Filtered Cigarettes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are non-institutionalized, and
- 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
Show all 13Show fewer
- 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
Who cannot join
- Do not meet one or more of the above inclusion criteria, or
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
California State University San Marcos
San Marcos, California, 92096
About this study
Official title: A Randomized Cross-over Clinical Trial of Unfiltered Cigarettes
This study is an open-label, randomized, 9-week, two-sequence, two-treatment, cross-over clinical trial of 40 adult filtered cigarette smokers who switch to unfiltered cigarettes There will be a 1-week baseline period, 2 weeks of smoking filtered or unfiltered cigarettes (determined at time of randomization), and a 3-week washout period, followed by post-washout baseline week, and a crossover to 2 weeks of smoking the opposite condition.
Read the detailed description
This innovative research project will assess the acceptability among committed smokers of switching to unfiltered cigarettes from filtered cigarettes and compare the measurement of exposure to nicotine and carcinogens after such a switch from filtered to unfiltered cigarettes. Such research will inform regulatory policy regarding the possibility of banning filters from the U.S. cigarette market. This high-impact pilot project is a randomized, cross-over clinical trial among smokers to measure changes in their puffing behavior, carcinogen exposures, nicotine exposure, and attitudes toward smoking unfiltered cigarettes if they were to no longer able to buy filtered cigarettes. The overall objective for this pilot trial is to collect preliminary data to inform design of a larger clinical trial in assessing changes in attitudes toward smoking unfiltered cigarettes; smoking topography; and urinary cotinine, urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), and volatile organic compound (VOC) excretion resulting from switching from filtered to unfiltered cigarettes among a sample of committed smokers.
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
- Cigarette Smoking, Tobacco Smoking
- Being tested
- Unfiltered Cigarettes, Filtered Cigarettes
- Keywords
- Cigarette filters, Cigarette smoking, Unfiltered cigarettes
- Medical subject headings
- Cigarette Smoking, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unfiltered CigarettesOther
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 CigarettesOther
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 | Role | What they receive |
|---|---|---|
| Study Group 1 | Active comparator | 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. Receives: Other: Unfiltered Cigarettes; Other: Filtered Cigarettes |
| Study Group 2 | Experimental | 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. Receives: Other: Unfiltered Cigarettes; Other: Filtered Cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean flow rate (mL/s)
Mean flow rate, in mL per second, measures the flow of air through the CReSS as participants smoke cigarettes.
Measured: 9 weeks
Change in number of puffs per cigarette
Measured by the CReSS device as participants smoke cigarettes
Measured: 9 weeks
Change in duration of each cigarette puff (in seconds)
Measured by the CReSS device as participants smoke cigarettes
Measured: 9 weeks
Change in inter-puff interval in seconds
The time between puffs on the cigarette, measured by the CReSS device as participants smoke cigarettes
Measured: 9 weeks
Change in volume of each puff (mL)
Measured by the CReSS device as participants smoke cigarettes
Measured: 9 weeks
Change in total smoke intake (mL)
Measured by the CReSS device as participants smoke cigarettes
Measured: 9 weeks
Secondary outcomes (5)
Urinary biomarker measurements
Target analytes are creatinine (the main proximate metabolite of nicotine), total (free + conjugated) 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (tNNAL, a carcinogenic tobacco-specific n-nitrosamine metabolite specific to tobacco smoke exposure), and a set of eight volatile organic compounds (VOCs, potentially toxic by-products of tobacco combustion). VOC concentrations will be measured at baseline in this study to account for possible additional sources of VOC exposure (assuming subjects' additional exposure remains consistent). VOCs will be measured as their urinary metabolites; i.e., mercapturic acid derivatives. The target parent VOCs are ethylene oxide, 1,3 butadiene, crotonaldehyde, acrolein, benzene, acrylamide, acrylonitrile, and propylene oxide. The biomarkers' urine concentration will be normalized to creatinine. Baseline midstream urine samples of at least 30 mL will be collected at baseline, post-washout, and at the end of each study cigarette period.
Measured: 9 weeks
Cigarette satisfaction: mCEQ
Satisfaction with test cigarettes will be assessed using the 12-item modified Cigarette Evaluation Scale (mCEQ). This validated tool uses visual analog scales to assess subjective ratings: general acceptability ("bad" to "very good"), smoking need ("not at all" to "very strong"), smoking satisfaction ("not at all" to "very good"), harshness ("not at all" to "very strong") and pleasantness of smoke taste ("not tasty at all" to "very tasty"). Open-ended questions will also be asked regarding subject's experience smoking unfiltered cigarettes.
Measured: 9 weeks
Change in answers to Stanford Perceptions Survey of Youth questions
Qualitative questions assessing knowledge abut cigarette filters, behaviors if filtered cigarettes were no longer available, and support for policy related to filtered cigarettes.
Measured: 9 weeks
Change in perceptions of cigarette harshness
As measured by a visual analog scale of 0 (not harsh at all) to 100 (extremely harsh)
Measured: 9 weeks
Change in perceptions of cigarette draw
As measured by a visual analog scale of 0 (very hard to draw smoke) to 100 (very easy to draw smoke)
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start17 Jan 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (49)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants receive one of two alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- California State University, San Marcos, Tobacco Related Disease Research Program
- Responsible party
- Principal investigator, Eyal Oren, San Diego State University
- Investigators
- Eyal Oren, Ph.D., Principal investigator, San Diego State University School of Public HealthKimberly Pulvers, Ph.D., Study director, California State University, San Marcos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749876
- Sponsor's protocol ID
- TRDRP Award #580582
- Status last verified
- Oct 2020
- First submitted
- 17 Nov 2018
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD), including a data dictionary, will be shared with the study's Data Safety and Monitoring Board (DSMB), or potentially with other collaborators in the future. It is not yet determined if there will be a plan to make the IPD available.
Publications
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.
PubMed 11347536Ito 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.
PubMed 20589676Brooks 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.
PubMed 15767332Song 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.
PubMed 28525914Novotny 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.
PubMed 25152862Slaughter 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.
PubMed 21504921Thun 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.
PubMed 23343064Connolly 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.
PubMed 23485704Harris B. The intractable cigarette 'filter problem'. Tob Control. 2011 May;20 Suppl 1(Suppl_1):i10-6. doi: 10.1136/tc.2010.040113.
PubMed 21504917Czoli 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.
PubMed 24012064Samet 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.
PubMed 28525913Djordjevic 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.
PubMed 10639511Pauly 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.
PubMed 11893815Novotny 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.
PubMed 21504918Oren 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.
PubMed 28293431
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Cross-over Clinical Trial of Unfiltered Cigarettes
- ClinicalTrials.gov ID
- NCT03749876
- Acronym / sponsor ID
- TRDRP Award #580582
- Conditions
- Cigarette Smoking, Tobacco Smoking
- Keywords
- Cigarette filters, Cigarette smoking, Unfiltered cigarettes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- California State University, San Marcos, Tobacco Related Disease Research Program
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 21 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open-label, randomized, 9-week, two-sequence, two-treatment, cross-over clinical trial of 40 adult filtered cigarette smokers who switch to unfiltered cigarettes There will be a 1-week baseline period, 2 weeks of smoking filtered or unfiltered cigarettes (determined at time of randomization), and a 3-week washout period, followed by post-washout baseline week, and a crossover to 2 weeks of smoking the opposite condition.
Detailed description
This innovative research project will assess the acceptability among committed smokers of switching to unfiltered cigarettes from filtered cigarettes and compare the measurement of exposure to nicotine and carcinogens after such a switch from filtered to unfiltered cigarettes. Such research will inform regulatory policy regarding the possibility of banning filters from the U.S. cigarette market. This high-impact pilot project is a randomized, cross-over clinical trial among smokers to measure changes in their puffing behavior, carcinogen exposures, nicotine exposure, and attitudes toward smoking unfiltered cigarettes if they were to no longer able to buy filtered cigarettes. The overall objective for this pilot trial is to collect preliminary data to inform design of a larger clinical trial in assessing changes in attitudes toward smoking unfiltered cigarettes; smoking topography; and urinary cotinine, urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), and volatile organic compound (VOC) excretion resulting from switching from filtered to unfiltered cigarettes among a sample of committed smokers.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants receive one of two alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study.
| Arm | Type | Receives |
|---|---|---|
| Study Group 1 | Active comparator | Other: Unfiltered Cigarettes, Other: Filtered CigarettesStudy 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. |
| Study Group 2 | Experimental | Other: Unfiltered Cigarettes, Other: Filtered CigarettesStudy 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Are non-institutionalized, and
- 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
Key exclusion criteria (11 listed)
- Do not meet one or more of the above inclusion criteria, or
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unfiltered CigarettesParticipants 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. | Other | Study Group 1, Study Group 2 |
| Filtered CigarettesParticipants 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. | Other | Study Group 1, Study Group 2 |
Primary outcome
Change in mean flow rate (mL/s)
Time frame: 9 weeks
Mean flow rate, in mL per second, measures the flow of air through the CReSS as participants smoke cigarettes.
Change in number of puffs per cigarette
Time frame: 9 weeks
Measured by the CReSS device as participants smoke cigarettes
Change in duration of each cigarette puff (in seconds)
Time frame: 9 weeks
Measured by the CReSS device as participants smoke cigarettes
Change in inter-puff interval in seconds
Time frame: 9 weeks
The time between puffs on the cigarette, measured by the CReSS device as participants smoke cigarettes
Change in volume of each puff (mL)
Time frame: 9 weeks
Measured by the CReSS device as participants smoke cigarettes
Change in total smoke intake (mL)
Time frame: 9 weeks
Measured by the CReSS device as participants smoke cigarettes
5 secondary outcomes
Urinary biomarker measurements
Time frame: 9 weeks
Cigarette satisfaction: mCEQ
Time frame: 9 weeks
Change in answers to Stanford Perceptions Survey of Youth questions
Time frame: 9 weeks
Change in perceptions of cigarette harshness
Time frame: 9 weeks
Change in perceptions of cigarette draw
Time frame: 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Background: PubMed 11347536Hastrup 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.
- Background: PubMed 20589676Ito 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.
- Background: PubMed 15767332Brooks 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.
- Background: PubMed 28525914Song 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.
- Background: PubMed 25152862Novotny 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.
- Background: PubMed 21504921Slaughter 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.
- Background: PubMed 23343064Thun 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.
- Background: PubMed 23485704Connolly 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.
- Background: PubMed 21504917Harris B. The intractable cigarette 'filter problem'. Tob Control. 2011 May;20 Suppl 1(Suppl_1):i10-6. doi: 10.1136/tc.2010.040113.
- Background: PubMed 24012064Czoli 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.
- Background: PubMed 28525913Samet 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.
- Background: PubMed 10639511Djordjevic 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD), including a data dictionary, will be shared with the study's Data Safety and Monitoring Board (DSMB), or potentially with other collaborators in the future. It is not yet determined if there will be a plan to make the IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eyal Oren, Ph.D. principal investigator
San Diego State University School of Public Health
Kimberly Pulvers, Ph.D. study director
California State University, San Marcos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unfiltered Cigarettes and Filtered Cigarettes in people with Cigarette Smoking and Tobacco Smoking, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean flow rate (mL/s) (time frame: 9 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03749876, which also lists 49 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.