N/A
N=238
Very-Low Nicotine Cigarettes and Non-Daily Smokers
Smoking
Bottom Line
View on ClinicalTrials.gov: NCT02228824 ↗Enrolled (actual)
238
Serious AEs
1.3%
Results posted
Oct 2018
Primary outcome: Primary: Change in Cigarette Consumption — -1.6; -0.05 cigarettes per day — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Very low nicotine content cigarettes (Drug); Normal nicotine content cigarettes (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Saul Shiffman
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cigarette Consumption |
-1.6; -0.05 | <0.001 sig |
| SECONDARY Exposure Measure - Solanesol |
NA; NA | — |
| SECONDARY Exposure Measure - Smoking Topography |
501.20; 539.70 | 0.041 sig |
| SECONDARY Exposure Measure - Cotinine (Logged) |
-0.84; -0.15 | 0.016 sig |
| SECONDARY Exposure Measure - Cigarette Butt Weight |
0.58; 0.60 | 0.03 sig |
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) on how best to regulate tobacco products in the future, with the goal of improving public health.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02228824). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.