Clinical Trials Logo

Clinical 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 3-week washout period, followed by post-washout baseline week, and a crossover to 2 weeks of smoking the opposite condition.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03749876
Study type Interventional
Source San Diego State University
Contact
Status Completed
Phase N/A
Start date January 17, 2019
Completion date June 30, 2020

See also
  Status Clinical Trial Phase
Completed NCT04043728 - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Active, not recruiting NCT02643914 - Control Systems Approach to Predicting Individualized Dynamics of Nicotine Cravings N/A
Recruiting NCT02422914 - Benefits of Tobacco Free Cigarette N/A
Active, not recruiting NCT02629679 - Sports, Education and Consumption of Substances in Adolescents N/A
Completed NCT02385227 - Characterization of Biomarkers of Tobacco Exposure, Urge-to-Smoke Following Exclusive and Dual Ad Lib Use of Electronic Cigarettes N/A
Completed NCT02218281 - Developing a Smartphone App With Mindfulness Training for Teen Smoking Cessation N/A
Completed NCT01199380 - Behavioral Activation Intervention for Smoking Cessation in Smokers With Depressive Symptoms Phase 2
Completed NCT01692353 - Cardiovascular Disease Biomarkers in Smokers and Moist Snuff Consumers N/A
Completed NCT00756704 - The Effectiveness of Smoking Cessation Guidelines in the Emergency Department N/A
Completed NCT01081119 - Brief Voluntary Alcohol and Drug Intervention for Middle School Youth Phase 2
Completed NCT00802919 - Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors Phase 4
Completed NCT00682474 - School Nurse-Delivered Smoking Cessation Intervention Phase 2/Phase 3
Completed NCT05520775 - Semaglutide for Alcohol Use Disorder Phase 2
Completed NCT03743532 - E-Cigarettes and Financial Incentives to Promote Tobacco Harm Reduction Among Adults Accessing Shelter Services N/A
Terminated NCT03840694 - Nicotine Withdrawal and Reward Processing: Connecting Neurobiology to Real-world Behavior N/A
Completed NCT06032793 - Effects of Deep Breathing Exercise on Pulmonary Function, Perceived Stress and Physical Fitness. N/A
Terminated NCT03326128 - High Dose Bupropion for Smoking Cessation - Pilot Study Phase 2
Recruiting NCT03218670 - Your Health in On Click N/A
Completed NCT02538042 - Strengthening Instrumental Extinction to Prevent Smoking Relapse (VLNCCue) N/A