NCT04979013

BRP1802 Smoking Abstinence Study

BRP1802 Changes in Biomarkers of Potential Harm Over Two Weeks of Smoking Abstinence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: RAI Services Company · Industry
• Sex: All
• Age: 24 Years – 60 Years
• Healthy volunteers: Accepted

Summary

A single-center study designed to evaluate changes in short-term biomarkers of potential harm (BoPH) in healthy adult cigarette smokers of two age groups (Group A: 24-34 years; Group B: 35-60 years) during 14 days of smoking abstinence.

Detailed description

The overall goal of the smoking abstinence study is to discover and assess biomarkers that respond rapidly to smoking abstinence and explore whether the smokers' age influences the responsiveness of biomarkers to changes in smoking status. The study is a single-center, parallel cohort, in which generally healthy adult male and female smokers participated. Smokers of 10-30 cigarettes per day for at least 5 years prior to screening were recruited. Plasma and urine (24h and spot urine) samples and other biological specimens will be collected at the baseline and at specified timepoints during the course of the study. The study will include two primary study cohorts, smokers ages 24-34 years and 35-60 years, to determine whether age could be a confounder in the qualification of biomarkers. Starting on Day -2, eligible smokers will be confined at the clinical site for 17 days. Biological samples will be collected on Days -2 and -1 for baseline study endpoints. On Day 1, smokers will be switched to smoking abstinence for 14 days. Samples will be collected for endpoint analysis throughout the 14-day abstinence period.

Conditions

• Smoking
• Smoking Cessation
• Tobacco Use

Interventions

Type	Name	Description
OTHER	Smoking Abstinence	Smokers will be switched to smoking abstinence for 14 days

Timeline

• Start date: 2019-05-30
• Primary completion: 2019-12-05
• Completion: 2019-12-05
• First posted: 2021-07-27
• Last updated: 2021-07-27

Locations

1 site across 1 country: United States