NCT02432729

A Smoking Cessation Study to Understand the Biological and Functional Changes After One Year of Smoking Cessation

A Multi-center, Multi-region Smoking Cessation Study to Understand the Biological and Functional Changes Related to Smoking Cessation in Healthy Smokers Who Are Continuously Abstinent From Smoking for One Year

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,184 (actual)
• Sponsor: Philip Morris Products S.A. · Industry
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to understand the biological and functional changes after one year of smoking cessation and to collect data on a broad range of biomarkers of exposure (BoExp) and biomarkers of effect (BoE).

Detailed description

This was a 12 month, multi-region, multi-center, ambulatory study conducted in the US, Japan and Europe. Smokers who were willing to quit smoking within the next 30 days at the Screening Visit were enrolled to reach approximately 950 subjects continuously abstinent from smoking from Actual Quit Date (AQD) onwards at week 2, in order to achieve at least 190 successful quitters expected to complete the study. Once approximately 950 subjects reached week 2, screening and enrollment were stopped. Compliance with smoking abstinence was verified by self-reporting, CO breath tests, and urine cotinine tests. Smokers who were not continuously abstinent from smoking \[i.e., free from tobacco product use (e.g., CC, pipes, cigars, snus) or any nicotine-containing product (including electronic cigarettes) other than nicotine replacement therapy (NRT)\] from their AQD onwards were discontinued from the study. At the end of the study, 358 subjects were verified as continuously abstinent from their AQD.

Conditions

• Cigarette Smoking

Timeline

• Start date: 2015-05-05
• Primary completion: 2017-05-31
• Completion: 2018-04-27
• First posted: 2015-05-04
• Last updated: 2023-01-30
• Results posted: 2019-08-26

Locations

5 sites across 5 countries: United States, Germany, Japan, Poland, United Kingdom