P r o d u c t S t a n d a r d s f o r R e d u c i n g N i c o t i n e i n C i g a r e t t e s Eric C. Donny, Ph.D. Professor, Department of Psychology, University of Pittsburgh Director, Center for the Evaluation of Nicotine in Cigarettes Funding Research reported in this publication was supported by the National Institute on Drug Abuse and Food and Drug Administration Center for Tobacco Products (U54 DA031659). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the Food and Drug Administration.
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Product Standards for Reducing Nicotine in Cigarettes
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Product Standards for Reducing Nicotine in Cigarettes
Eric C. Donny, Ph.D.
Professor, Department of Psychology, University of Pittsburgh
Director, Center for the Evaluation of Nicotine in Cigarettes
FundingResearch reported in this publication was supported by the National Institute on Drug Abuse and Food and
Drug Administration Center for Tobacco Products (U54 DA031659). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the
• Enables FDA to set product standards for nicotine• Cannot be reduced to zero• Must consider the risks and benefits to the population as a
whole including users and nonusers
Family Smoking Prevention and Tobacco Control Act
Would a product standard requiring very low nicotine levels reduce cigarette use and improve
public health?
Two sources of data for today
Large clinical trial Rat self-administration
Donny et al., 2015
• Purpose: To determine how use of cigarettes varying in nicotine content impacts a wide range of outcomes in a large study of smokers not currently interested in quitting
• No incentive for compliance (or penalty for non-compliance) with study product
• Emphasis on honest reporting
Design
Study sites
Sample characteristics
• Age: 42• Female: 42.3%• African American: 39.7%• High school or less: 44.2%• Menthol preferred: 57%• CPD: 15.5• CO: 15.1• FTND: 5.1
Does nicotine reduction lead to reduced smoking?
Dose-dependent reduction in total CPD
Cigarettes per day
Dose-dependent reduction in total CPD
Donny E.C. et al., 2015, NEJM, 373, 1340-9
Dose-dependent reduction in total CPD
Cigarettes per day
Dose-dependent reduction in total CPD
Donny E.C. et al., 2015, NEJM, 373, 1340-9
Cigarettes per day
Donny E.C. et al., 2015, NEJM, 373, 1340-9
Cigarettes per day
Donny E.C. et al., 2015, NEJM, 373, 1340-9
Cigarettes per day
Donny E.C. et al., 2015, NEJM, 373, 1340-9
Cigarettes per day
Donny E.C. et al., 2015, NEJM, 373, 1340-9
Cigarettes per day
***
5.2 and above ↑2.4 and below ↓
*indicates significant (p<.0125) difference compared to 15.8 mg/g (controlling for BL)
*
Donny E.C. et al., 2015, NEJM, 373, 1340-9
Hypothetical CPD at $6/pack
*indicates significant (p<.0125) difference compared to 15.8 mg/g (controlling for BL)
***
*
*
Donny E.C. et al., 2015, NEJM, 373, 1340-9
Demand curve
*
0.4 mg/g15.8 mg/g
Cost 0
Take home point #1
Low nicotine content cigarettes reduce smoking relative to normal
nicotine cigarettes
CPD Elasticity of demand (hypothetical)
0.4 vs. 15.8 mg/g Reduced Reduced
Does nicotine reduction lead to compensatory smoking?
Light cigarettes have reduced nicotine yield. The content of the tobacco is the same.
With light cigarettes, smokers can and do compensate.
Machine yield Content and user exposure
These cigarettes actually contain less nicotine. It would be very difficult for smokers to adjust their
behavior to maintain nicotine levels.
Compensatory smoking
No significant differences
Compensatory smoking
Donny E.C. et al., 2015, NEJM, 373, 1340-9
Compensatory smoking
*indicates significant (p<.0125) difference compared to 15.8 mg/g (controlling for BL)
*
*
Donny E.C. et al., 2015, NEJM, 373, 1340-9
Compensatory smoking
• Other studies also fail to find compensation that lasts beyond the first few cigarettes (Benowitz et al. 2012; Hatsukami et al., 2010, 2013, 2015; Donny et al., 2007; Donny and Jones, 2009; MacQueen et al., 2012)• CPD – similar or less than controls• Carbon monoxide – similar or less than controls• Puff Volume – similar or less than controls
• It is possible some subgroups will compensate (e.g., high dependence; Bandiera et al., 2015)
Take home point #2
Minimal evidence of compensatory smoking
CPD CO Puff volume Filter analysis
0.4 vs. 15.8 mg/g Reduced Similar Reduced Underway
Does nicotine reduction lead to decreases in nicotine exposure?
***
Biomarkers of exposure
*
*indicates significant (p<.0125) difference compared to 15.8 mg/g (controlling for BL)
*
Donny E.C. et al., 2015, NEJM, 373, 1340-9
Content vs. Exposure
Nicotine exposureNicotine content
Donny E.C. et al., 2015, NEJM, 373, 1340-9
15.8
0.4↓97%
↓57%
The “Hotel Study”• 24 participants smoked only
0.4 mg/g SPECTRUM while residing at a hotel for 4 nights.
• Nicotine exposure decreased by at least 92-94%
↓94%
↓92%
Non-adherence • Self-report: Each week, 30-60% of participants
assigned to reduced nicotine cigarettes reported smoking other cigarettes. • How much? 2-4 CPD (median when non-compliant)• When? Most often first thing in morning
• Biomarkers: TNE at week 6 • Only about 25% of participants in the 0.4 mg/g groups had
TNE < 6.4 nmol/ml
Take home point #3
Low nicotine content cigarettes reduce nicotine exposure, but
people seek out other sources of nicotine
Clinical trialTNE
HotelTNE
Clinical trial UB cigs
0.4 vs. 15.8 mg/g Reduced 57% Reduced >94% Increased
Does nicotine reduction reduce dependence and/or lead to
quitting?
Dependence
**
*indicates significant (p<.0125) difference compared to 15.8 mg/g (controlling for BL)
*
Donny E.C. et al., 2015, NEJM, 373, 1340-9
Dependence
*
*indicates significant (p<.0125) difference compared to 15.8 mg/g (controlling for BL)
Donny E.C. et al., 2015, NEJM, 373, 1340-9
Quit attempts
*
*indicates significant (p<.0125) difference compared to 15.8 mg/g
*
Donny E.C. et al., 2015, NEJM, 373, 1340-9
Cigarettes per day
**
*indicates significant (p<.0125) difference compared to 15.8 mg/g (controlling for BL)
*
Donny E.C. et al., 2015, NEJM, 373, 1340-9
Take home point #4
Low nicotine content cigarettes reduce nicotine dependence and may increase the likelihood that
smokers will try to quit
FTND & WIDSM
Quit attemptsat Follow-up
CPD at Follow-up
0.4 vs. 15.8 mg/g Reduced Increased Reduced
Does nicotine reduction lead to other potentially harmful