Clinical Trials Logo
  1. Home
  2. Tobacco Use
  3. NCT03715491

Filter Ventilation — COMET2P1  

Tobacco Use Clinical Trial

Official title:
Clinical Trial to Assess the Removal of Filter Ventilation on Smoking Behavior and Biomarkers

Clinical Trial Summary

The goal of this study is to determine the biomarkers of exposure and harm as well as the pattern of product purchase when ventilated vs. unventilated cigarettes are available in the marketplace with and without alternative nicotine delivery systems (ANDS).

The primary aim of this study is to examine the effects of cigarette filter ventilation on biomarkers of toxicant exposure and toxicity and smoking behavior (cigs/day), with or without the availability of ANDS.

Clinical Trial Description

This randomized, open label, controlled multi-site study will simulate a "real world" tobacco environment by providing access to an experimental marketplace where they will be given vouchers that can be exchanged for assigned study cigarettes (either ventilated or unventilated) and two of the groups will also have access to non-combusted tobacco/nicotine products.

Subjects (N=550; N=125 in each group) will be randomly assigned to: 1) Ventilated cigarettes only; or 2) Unventilated cigarettes only; 3) Ventilated cigarettes + alternative nicotine delivery systems (ANDS); 4) Unventilated cigarettes + ANDS.

Smokers will undergo an in person screening and then a 10 week experimental trial with one week of baseline; 2 weeks of usual brand cigarettes in the marketplace and 8 weeks on the study cigarettes in the marketplace. The experimental period will simulate a "real world" environment by providing participants with vouchers for a specified number of points that can be exchanged for study cigarettes and/or ANDS. At the end of the study they can exchange unspent points for money.

Biomarker samples (total nicotine equivalents, tobacco specific nitrosamines, volatile organic compound and inflammation markers), smoking topography and inhalation measures are taken at baseline and end of trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03715491
Study type Interventional
Source University of Minnesota - Clinical and Translational Science Institute
Contact Joni Jensen, MPH
Phone 612-6245178
Email jense010@umn.edu
Status Recruiting
Phase Phase 3
Start date October 25, 2018
Completion date September 30, 2022
View Details
See also
  Status Clinical Trial Phase
Completed NCT04043728 - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study N/A
Recruiting NCT06033599 - Motivational Interviewing and Mindfulness-Oriented Recovery Enhancement Phase 3
Enrolling by invitation NCT05415371 - Persistent Poverty Counties Pregnant Women With Medicaid N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Completed NCT06105424 - BRP1602: Evaluation of Technical and Logistical Feasibility to Measure Lung Permeability N/A
Completed NCT01311830 - Enhancing Smoker Utilization of the Minnesota Quitline Through Support Persons N/A
Completed NCT04566198 - Smoking in the Paris Fire Brigade and Comparison According to the Type of Service (Permanent or On-call)
Completed NCT04107779 - Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to JUUL ENDS N/A
Completed NCT05092919 - The Effect of Sweet Flavoring on the Rewarding and Reinforcing Value of Cigarillo Use Among Young Adults Early Phase 1
Terminated NCT05274217 - Journey of Transformation Curriculum for Native American Adolescents N/A
Enrolling by invitation NCT06042361 - Enhancing Equity in Smoke-free Housing N/A
Recruiting NCT05380765 - Developing a Positive Approach to Substance Use Prevention in North American Indian Adolescents N/A
Withdrawn NCT03352635 - Mechanisms of Ethnic/Racial Differences in Lung Cancer Due to Cigarette Smoking Clinical and Biomarkers Core N/A
Completed NCT03235713 - EMA for Tobacco Control Policy Research
Completed NCT03151421 - Air Quality Feedback to Reduce Second-hand Smoke (SHS) Exposure in the Home N/A
Completed NCT03446170 - Effect of Cigarette Pack Warnings and Packaging Among Young Adult Smokers N/A
Completed NCT04104152 - CSD190203: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting N/A
Not yet recruiting NCT05999383 - Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration Phase 2
Recruiting NCT04429568 - THC Crossover Study N/A
Completed NCT04632030 - Shrinking the Size of the Tobacco Power Wall N/A