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A Study of Unfiltered Cigarettes Among Committed Smokers

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ClinicalTrials.gov Identifier: NCT03749876
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : September 18, 2019
Sponsor:
Collaborators:
California State University, San Marcos
Tobacco Related Disease Research Program
Information provided by (Responsible Party):
Eyal Oren, San Diego State University

Tracking Information
First Submitted Date  ICMJE November 17, 2018
First Posted Date  ICMJE November 21, 2018
Last Update Posted Date September 18, 2019
Actual Study Start Date  ICMJE January 17, 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2018)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2018)
  • Urinary biomarker measurements [ Time Frame: 9 weeks ]
    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.
  • Cigarette satisfaction: mCEQ [ Time Frame: 9 weeks ]
    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.
  • Change in answers to Stanford Perceptions Survey of Youth questions [ Time Frame: 9 weeks ]
    Qualitative questions assessing knowledge abut cigarette filters, behaviors if filtered cigarettes were no longer available, and support for policy related to filtered cigarettes.
  • Change in perceptions of cigarette harshness [ Time Frame: 9 weeks ]
    As measured by a visual analog scale of 0 (not harsh at all) to 100 (extremely harsh)
  • Change in perceptions of cigarette draw [ Time Frame: 9 weeks ]
    As measured by a visual analog scale of 0 (very hard to draw smoke) to 100 (very easy to draw smoke)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Unfiltered Cigarettes Among Committed Smokers
Official Title  ICMJE A Randomized Cross-over Clinical Trial of Unfiltered Cigarettes
Brief 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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 (Investigator, Outcomes Assessor)
Masking Description:
The research staff performing the statistical analyses of the outcomes of interest will be masked from knowing the individuals' randomized treatment assignments, as will the principal investigator.
Primary Purpose: Basic Science
Condition  ICMJE
  • Cigarette Smoking
  • Tobacco Smoking
Intervention  ICMJE
  • Other: 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.
  • Other: 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 Arms  ICMJE
  • Active Comparator: 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.
    Interventions:
    • Other: Unfiltered Cigarettes
    • Other: Filtered Cigarettes
  • Experimental: 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.
    Interventions:
    • Other: Unfiltered Cigarettes
    • Other: Filtered Cigarettes
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 19, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Study Coordinator 619-839-9630 filterstudy.csusm.sdsu@gmail.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03749876
Other Study ID Numbers  ICMJE TRDRP Award #580582
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: 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.
Responsible Party Eyal Oren, San Diego State University
Study Sponsor  ICMJE San Diego State University
Collaborators  ICMJE
  • California State University, San Marcos
  • Tobacco Related Disease Research Program
Investigators  ICMJE
Principal Investigator: Eyal Oren, Ph.D. San Diego State University School of Public Health
Study Director: Kimberly Pulvers, Ph.D. California State University, San Marcos
PRS Account San Diego State University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP