A Study of Unfiltered Cigarettes Among Committed Smokers
Condition: Cigarette Smoking; Tobacco Smoking
Study type: Interventional

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.
    

Intervention name(s): Unfiltered Cigarettes; Filtered Cigarettes
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
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)
Primary purpose: Basic Science
Keywords: Cigarette filters; Cigarette smoking; Unfiltered cigarettes