CENIC2 P1 (Nicotine Use) - Clinical Trial

What is the Purpose of this Study?

If you choose to join this study, you will:
- Complete three study phases, including 14 study visits that last from 1-2.5 hours each 
-- Phase 1: Two weekly baseline assessment periods where you will continue to smoke your usual brand cigarette  
-- Phase 2: Two weekly visits during which you will be introduced to our web-based marketplace (online store) where you will be given vouchers to exchange for your usual brand cigarettes and/or other nicotine or tobacco products (e.g. nicotine replacement therapy, e-cigarettes, snuff, or snus)  
-- Phase 3: You will be randomized (like a flip of a coin) to either very low nicotine content cigarettes or normal nicotine content cigarettes and have 8 clinic visits over 12 weeks.
---- You will continue to access our marketplace for 12 weeks during which you can exchange vouchers for your study cigarette and/or the other nicotine or tobacco products.  

What is the Condition Being Studied?

Cigarette smoking

Who Can Participate in the Study?

Adults who smoke daily and:
- Have no unstable health conditions or unstable use of medication(s)
- Don't have a positive drug screen (except for marijuana)
- Aren't pregnant or nursing

Age Group

What is Involved?

We are doing this study to understand how smoking a very low nicotine content (VLNC) cigarette compared to smoking a cigarette with nicotine levels about the same as your usual brand may affect your tobacco use and health.

This study looks at whether you choose to use nicotine products, like nicotine gum or patch, e-cigarettes, or other tobacco products while you are assigned to the study cigarettes. 

Study Details

Full Title
Impact of Very Low Nicotine Content Cigarettes in a Complex Marketplace
Principal Investigator
Francis McClernon
Protocol Number
IRB: PRO00086465
NCT: NCT03272685
Phase III
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center