NCT02139930

Project 2: Strategies for Reducing Nicotine Content in Cigarettes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,250 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main goal of this project is to compare two different approaches to reducing levels of nicotine in cigarettes: an immediate reduction in nicotine content in cigarettes to non-addictive levels or a gradual reduction in nicotine content in cigarettes to non-addictive levels. These two approaches will then be contrasted to a group that continues to smoke cigarettes with nicotine content similar to conventional cigarettes.

Detailed description

This project will be conducted to compare product use patterns and biomarkers of exposure between smokers who are assigned to a) gradual reduction in reduced nicotine content (RNC) cigarettes; b) immediate reduction to very low nicotine content (VLNC) cigarettes or c) normal nicotine content (NNC) cigarettes. The outcomes from this study will provide information on different approaches to reducing levels of nicotine in cigarettes and will determine the approach with the most optimal outcomes taking into account the balance between overall risk reduction (possibly maximized by abrupt switching) and compliance and acceptability (possibly maximized by gradual reduction of RNC cigarettes).

Conditions

• Nicotine Dependence
• Tobacco Smoking

Interventions

Type	Name	Description
BEHAVIORAL	Normal Nicotine Control Group	Participants will smoke experimental cigarettes for a period of 20-weeks.
BEHAVIORAL	Immediate Nicotine Reduction Group	Participants will smoke experimental cigarettes for a period of 20-weeks.
BEHAVIORAL	Gradual Nicotine Reduction Group	Participants will smoke experimental cigarettes for a period of 20-weeks.

Timeline

• Start date: 2014-09-01
• Primary completion: 2017-03-01
• Completion: 2017-03-14
• First posted: 2014-05-16
• Last updated: 2018-08-15

Locations

10 sites across 1 country: United States