Status:
COMPLETED
Very-Low Nicotine Cigarettes and Non-Daily Smokers
Lead Sponsor:
Saul Shiffman
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Smoking
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this research study is to investigate the impact of different nicotine levels in cigarettes among non-daily smokers. This research may help inform the Food and Drug Administration (FDA)...
Detailed Description
The overall goal of the study is to assess the effects of switching to Very-Low-Nicotine-Content cigarettes (VLNCCs) among non-daily, or intermittent smokers (ITS). This is a two-arm randomized study ...
Eligibility Criteria
Inclusion
- age 18 years or older, and smoking cigarettes for at least 3 years
- smoking, on average, 4-27 days per month
- smoking at current rate for at least the previous 3 months
- willingness to try novel cigarettes
Exclusion
- active plans to quit or actively seeking smoking cessation treatment in the next 3 months
- severe psychiatric disorders that may interfere with study procedures
- current, regular (i.e., monthly or more) use of nicotine replacement or other tobacco products, by self-report
- exclusive use of roll-your-own cigarettes (since the study uses manufactured cigarettes)
- \[for female participants\] being pregnant or breastfeeding, or planning to become pregnant, by self-report
- current use of medications such as Chantix (varenicline), Zyban, Wellbutrin, or bupropion for any purpose, including stopping smoking
- occurrence of heart attack, stroke, or angina in the past 3 months
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2017
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT02228824
Start Date
June 1 2015
End Date
July 31 2017
Last Update
October 31 2018
Active Locations (1)
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1
Smoking Research Group, University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213