NCT03571724

A Study to Assess Changes in Cigarette Consumption During a Switch to Very Low Nicotine Cigarettes

A Longitudinal Ambulatory Study to Assess Changes in Cigarette Consumption and Biomarkers of Exposure During a 6-week Switch to Very Low Nicotine Cigarettes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: 22nd Century Group, Inc. · Industry
• Sex: All
• Age: 26 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the impact of switching from usual brand cigarettes to very low nicotine cigarettes on cigarette consumption, smoking behavior, and biomarkers of exposure.

Detailed description

Very low nicotine (VLN) cigarettes contain a 'non-additive' level of nicotine. This study will switch smokers from their usual brand to VLN cigarettes. Periodically during the study the investigators will collect blood and measure nicotine exposure and also other biomarkers to see what effect switching has. The participants will also use a diary to record number of cigarettes smoked. Cigarette butts will also be collected.

Conditions

• Tobacco Use

Interventions

Type	Name	Description
OTHER	Non-Menthol Very Low Nicotine Cigarettes	King size non-menthol cigarettes containing 0.4mg nicotine /g tobacco
OTHER	Menthol Very Low Nicotine Cigarettes	King size menthol cigarettes containing 0.4mg nicotine /g tobacco
OTHER	Subject's UB non-mentholated filtered cigarettes	King size non-menthol cigarettes
OTHER	Subject's UB mentholated filtered cigarettes	King size menthol cigarettes

Timeline

• Start date: 2018-06-28
• Primary completion: 2019-01-25
• Completion: 2019-03-08
• First posted: 2018-06-28
• Last updated: 2020-09-16
• Results posted: 2020-09-16

Locations

2 sites across 1 country: United States