Nicotine Reduction: Harm Reduction not Prohibition

Transcription

1 Nicotine Reduction: Harm Reduction not Prohibition Eric C. Donny, Ph.D. Endowed Professor, Departments of Physiology & Pharmacology and Social Sciences & Health Policy Director, Center for the Evaluation of Nicotine in Cigarettes Wake Forest University School of Medicine 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.

2 The science of nicotine reduction Key observations

3 Key observations Reduced smoking Donny et al., 2015

4 Key observations Reduced but persistent smoking 15 CPD Donny et al., 2015

5 Key observations Reduced but persistent smoking Little evidence of compensation Donny et al., 2015

6 Key observations Reduced but persistent smoking Little evidence of compensation Reduced dependence * * Donny et al., 2015

7 Key observations Reduced but persistent smoking Little evidence of compensation Reduced dependence Increased quit attempts and abstinence Donny et al., 2015 Hatsukami, unpublished observations

8 Key observations Reduced but persistent smoking Little evidence of compensation Reduced dependence Increased quit attempts and abstinence Non-compliance is common Nardone et al., 2016, Addiction 111:

9 Key observations Reduced but persistent smoking Little evidence of compensation Reduced dependence Increased quit attempts and abstinence Non-compliance is common Reduced smoking satisfaction mceq Satisfaction Usual Brand 12.0 mg/g 5.7 mg/g 0.4 mg/g Hatsukami et al., 2013, NTR 15:

10 Key observations Reduced but persistent smoking Little evidence of compensation Reduced dependence Increased quit attempts and abstinence Non-compliance is common Reduced smoking satisfaction Increased withdrawal

11 Least harmful Key observations Reduced but persistent smoking Little evidence of compensation Reduced dependence Increased quit attempts and abstinence Non-compliance is common Reduced smoking satisfaction Increased withdrawal Reducing nicotine will facilitate behavior change Abstinence Medicinal Nicotine Electronic Products Smokeless Illicit Cigarettes Low Nicotine Cigarettes Little Cigars Cigarillos harmful Most

12 The Role of Alternative Nicotine Delivery Systems

13 The Role of Alternative Nicotine Delivery Systems Transdermal nicotine Small effect on smoking of VLNC cigarettes (Donny et al., 2009; Hatsukami et al., 2013)

14 The Role of Alternative Nicotine Delivery Systems Transdermal nicotine Small effect on smoking of VLNC cigarettes (Donny et al., 2009; Hatsukami et al., 2013) Decrease in non-compliance, but not to control levels

15 The Role of Alternative Nicotine Delivery Systems Range of alternatives Hatsukami et al. Addiction Jan;112(1): doi: /add.13603

16 Proportion of participants using alternative products The Role of Alternative Nicotine Delivery Systems (w/ combusted and non-combusted) Use of alternative products was associated with increased number of days abstinent from cigarettes (w/ non-combusted only) Very Low Nicotine Cigarettes Alternative Nicotine Delivery Systems Nicotine reduction was associated with an increase in days using alternative products (most commonly e-cigarettes) Hatsukami et al. Addiction Jan;112(1): doi: /add.13603

17 Is nicotine reduction necessary?

18 Is nicotine reduction necessary? The promise of ANDS Help some smokers reduce use and/or quit (Farsalinos et al., 2016) May be contributing to decline in youth smoking (Jamal et al., 2017) New products (e.g., HNB) may produce greater effect on smoking (Fojtik, 2017) Potential pitfalls Many smokers are yet to try ANDS (Farsalinos et al., 2016) Of those that have tried e-cigarettes, most find them unsatisfying, stop vaping, and continue to smoke (Pechacek et al., 2016; ASH, 2017) Misperceptions of harm relative to cigarettes persist and may be growing (ASH, 2017) Concerns about potential gateway effect (NASEM, 2018) Uncertainty about health effects of long term use (NASEM, 2018) Smith et al., 2018, Prev Med

19 Is nicotine reduction necessary? The biggest potential pitfall Cigarettes have a massive advantage Virtual monopoly on nicotine use for over 100 years Deeply embedded in personal history and culture with extensive expectations about the benefits of use (Harrell et al., 2015) Decades of product development designed to maximize nicotine delivery, product appeal, and addictiveness (Proctor, 2011) Smokers are addicted to specific product not just nicotine (Fagerstrom and Eissenberg, 2012) Relative to the immediate reward of cigarettes, smokers are likely to discount the potential benefits of switching to safer alternatives because those benefits are delayed in time (Bickel and Marsch, 2001) Cigarettes are the default for smokers (Loewenstein et al., 2007) Smith et al., 2018, Prev Med

20 Need for public health campaign about risk Pacek et al., 2017 Key messages Reducing nicotine in cigarettes is intended to prevent youth from smoking and to enable current smokers to quit Cigarettes with less nicotine are NOT safer cigarettes If you want to use nicotine, switching from cigarettes to other products could reduce your risk of disease

21 Conclusions Reducing nicotine in cigarettes Reduces but does not abolish smoking Does not lead to compensatory smoking Reduces dependence and increases quit attempts and abstinence Increases use of non-study cigarettes (i.e., non-compliance) which may be indicative of persistent demand for nicotine related to reduced smoking satisfaction and increased withdrawal Transdermal nicotine may further reduce smoking and reduce the demand for nicotine, but other alternative nicotine delivery systems are likely to have a greater effect. Public health messages should emphasize that nicotine is the major determinant of addiction but a minor determinant of harm The impact of ANDS in the absence of standards reducing nicotine in cigarettes could be limited. Reducing nicotine in combusted products will likely accelerate the shift in the products people use.

22 Reducing nicotine in cigarettes and providing appealing but safer substitutes may be complimentary approaches for rapidly reducing the harms associated with combusted tobacco use Thank you for listening