(2015 Randomized Trial of Reduced-Nicotine Standards for Cigarettes) |
Richardpruen (talk | contribs) (→Studies: Added study on illicit purchasing and ecig potentially diverting users to a safer product) |
||
| (28 intermediate revisions by 3 users not shown) | |||
| Line 1: | Line 1: | ||
[[file:VLNC.jpg|center]] | |||
<br> | |||
'''VLNC (Very Low Nicotine Cigarettes)''' | |||
For those who are new to smoking, it is hoped that with the low nicotine content people won't become addicted to them and convert to habitual smoking. For people who already habitually smoke, it is hoped that the lower level of nicotine will help them break free from smoking or if they want/need more nicotine, convert to a safer alternative. The US FDA granted the first MRTP (Modified Risk Tobacco Product) to a VLNC on December 23, 2021. | |||
*Terms: | |||
**VLN = Very Low Nicotine | |||
**VLNC = Very Low Nicotine Cigarettes | |||
**CPD = Cigarettes Per Day | |||
**RNC = Reduced Nicotine Cigarette (non-brand hypernym used in some papers) | |||
__TOC__ | __TOC__ | ||
<br> | |||
== Studies == | |||
== | === 2023: [https://pubmed.ncbi.nlm.nih.gov/37195268/ E-Cigarette price impacts legal and black-market cigarette purchasing under a hypothetical reduced-nicotine cigarette standard.] === | ||
== | * The authors looked at various conditions in a hypothetical marketplace that included VLN cigarettes, illicit cigarettes and e-cigarettes at different prices. | ||
* Some rare informative work on a reduced nicotine rule looks at choices made by users facing a market in which a nicotine rule has been imposed. This is an experimental economic study and, therefore, more closely approximates the behavioural processes involved in responding to a regulation that requires users to make economic choices (i.e. pay money to buy something they want). More so than, say, randomised controlled trials, which have very poor external validity and tell us very little beyond their high level of non-compliance. | |||
* Results: Usual-brand cigarette purchasing was greater than illicit normal-nicotine content cigarettes and less than reduced-nicotine content cigarettes. In the cross-commodity purchasing tasks, illicit cigarettes and e-cigarettes both served as economic substitutes for reduced-nicotine content cigarettes; however, when e-cigarettes were available for $4/pod, they were purchased at greater levels than illicit cigarettes and resulted in greater reductions in reduced-nicotine content cigarettes purchasing than when available for $12/pod. | |||
* Implications: E-cigarettes available at low, but not high, prices were stronger substitutes for legal, reduced-nicotine content cigarettes than illegal, normal-nicotine content cigarettes in a hypothetical reduced-nicotine tobacco market. Our findings suggest the availability of relatively inexpensive e-cigarettes may reduce illicit cigarette purchasing and combusted cigarette use under a reduced-nicotine cigarette standard. | |||
* There's an interesting and revealing [https://twitter.com/Drug_Researcher/status/1659281443040686091 Twitter thread] by senior author Matthew Johnson, Professor of Psychiatry and Behavioral Sciences at Johns Hopkins. Here are the headlines, starting with the resistance to publishing sceptical research about tobacco control Big Idea: | |||
** Had a hell of a time publishing this due to zealotry in nicotine research field. Never received money from tobacco/e-cig companies but have long recognized e-cigs as a powerful public health benefit to replace smoking. | |||
** I've long recognized the potential catastrophe of banning full nicotine cigarettes. As if a hundred years of drug prohibition of other substances has worked and as if the world isn't finally moving away from those failed policies. The cigarette black market would EXPLODE. | |||
** We need to view nicotine/tobacco in the broader context of drug policy. We need to recognize that e-cigs are inherently different than the debacle of "light" cigarettes which likely harmed public health. E-cigs poised to be far less deadly than cigarettes, esp if well regulated. | |||
* Dolan SB, Bradley MK, Johnson MW. Nicotine Tob Res. 2023 May 17:ntad067. doi: 10.1093/ntr/ntad067. Online ahead of print. PMID: 37195268 | |||
===2022: [https://academic.oup.com/ntr/advance-article-abstract/doi/10.1093/ntr/ntac010/6505261 Educating the public on the health risks of very low nicotine content cigarettes: Results from a U.S.-based convenience sample]=== | |||
*Messaging on mortality effects of VLNC cigarettes (i.e., cigarettes with 95% less nicotine are as deadly as current cigarettes) was associated with more accurate perceptions of the health risks of VLNC cigarettes than the control; however, misperceptions remained in one-third of participants. | |||
| Line 26: | Line 51: | ||
*Several participants expected, prior to trying VLNC cigarettes, to compensate for the reduced nicotine levels by smoking more cigarettes but were surprised when they did not increase their smoking. A subset of participants reported experiencing minor withdrawal symptoms, such as irritability and fatigue. Several participants reported feeling less dependent after exclusively smoking VLNC cigarettes. Most participants said they would smoke VLNC cigarettes if they were the only cigarettes available to purchase. Some also said that smoking VLNC cigarettes could help people taper down or quit smoking. | *Several participants expected, prior to trying VLNC cigarettes, to compensate for the reduced nicotine levels by smoking more cigarettes but were surprised when they did not increase their smoking. A subset of participants reported experiencing minor withdrawal symptoms, such as irritability and fatigue. Several participants reported feeling less dependent after exclusively smoking VLNC cigarettes. Most participants said they would smoke VLNC cigarettes if they were the only cigarettes available to purchase. Some also said that smoking VLNC cigarettes could help people taper down or quit smoking. | ||
===2021 [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7885770/ The Public Health Gains Had Cigarette Companies Chosen to Sell Very Low Nicotine Cigarettes]=== | |||
*Here we report that cigarette manufacturers have had the ability to voluntarily implement such a standard for decades. We use a well-validated model to demonstrate that millions of smoking attributable deaths and life-years lost would have been averted if the industry had implemented such a standard. | |||
| Line 34: | Line 62: | ||
====2020 Commentary: [https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2771865 Is Nicotine Reduction in Cigarettes Enough?]==== | ====2020 Commentary: [https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2771865 Is Nicotine Reduction in Cigarettes Enough?]==== | ||
*"Is this strong policy statement warranted by the findings in this study? We think not. The main finding—a modest within-trial reduction in cigarette consumption—does not support the objectives of the comprehensive plan for nicotine regulation at a national level. The ability of the VLNC intervention to promote smoking cessation was specifically tested at week 12 when participants were offered $100 to abstain from smoking for 24 hours, a modest goal given that most smokers who abstain for 24 hours relapse, and smokers do not get such offers in real life. The VLNC intervention did not result in smoking cessation. This raises serious questions about the conclusion that a VLNC cigarette policy alone would promote smoking cessation or reduce morbidity and mortality. The health benefits of VLNC cigarettes remain unclear. Reductions in the level of NNAL (4-[methylnitrosamino]-1-[3-pyridyl]-1-butanol), a biomarker for tobacco smoke carcinogens, were small, and 1 group (opioid users) experienced an increase in the level of NNAL." | *"Is this strong policy statement warranted by the findings in this study? We think not. The main finding—a modest within-trial reduction in cigarette consumption—does not support the objectives of the comprehensive plan for nicotine regulation at a national level. The ability of the VLNC intervention to promote smoking cessation was specifically tested at week 12 when participants were offered $100 to abstain from smoking for 24 hours, a modest goal given that most smokers who abstain for 24 hours relapse, and smokers do not get such offers in real life. The VLNC intervention did not result in smoking cessation. This raises serious questions about the conclusion that a VLNC cigarette policy alone would promote smoking cessation or reduce morbidity and mortality. The health benefits of VLNC cigarettes remain unclear. Reductions in the level of NNAL (4-[methylnitrosamino]-1-[3-pyridyl]-1-butanol), a biomarker for tobacco smoke carcinogens, were small, and 1 group (opioid users) experienced an increase in the level of NNAL." | ||
===2020 [https://www.sciencedirect.com/science/article/abs/pii/S0091743520302516 Abuse liability of cigarettes with very low nicotine content in pregnant cigarette smokers]=== | |||
*Ten pregnant smokers in Burlington, VT and Baltimore, MD participated in 2017–2018. | |||
*Reducing the nicotine content of cigarettes may decrease their abuse liability in pregnant smokers without causing untoward craving/withdrawal or compensatory smoking. Studies of extended exposure to VLNCs in pregnant women are warranted. | |||
===2020: [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7244375/ Differences in Acute Reinforcement Across Reduced Nicotine Content Cigarettes]=== | |||
*17 people completed the study. | |||
*Although replication with larger samples and longer access is needed, results indicate nicotine reduction to ≤2.3 mg/g in cigarettes would attenuate reinforcement. This choice procedure may efficiently inform future clinical trials to assess relative reinforcing effects of smoking reduced nicotine cigarettes. | |||
===2019: [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6939783/ Misperceptions of Nicotine and Nicotine Reduction: The Importance of Public Education to Maximize the Benefits of a Nicotine Reduction Standard]=== | |||
*Recent population-level data highlight that 49%–80% of US adults incorrectly believe that nicotine is responsible for most of the cancer caused by smoking | |||
*Nearly half (47%) of adult smokers believe that continued smoking of VLNC cigarettes is less likely to cause cancer than smoking their current cigarettes.This misperception is more common among smokers who are age 55+ (57%) and Black (57%). | |||
| Line 52: | Line 95: | ||
===2018: [https://jamanetwork.com/journals/jama/article-abstract/2698925 Effect of Immediate vs Gradual Reduction in Nicotine Content of Cigarettes on Biomarkers of Smoke Exposure]=== | ===2018: [https://jamanetwork.com/journals/jama/article-abstract/2698925 Effect of Immediate vs Gradual Reduction in Nicotine Content of Cigarettes on Biomarkers of Smoke Exposure]=== | ||
*In this study, compared with gradual nicotine reduction, immediate reduction was associated with lower toxicant exposure across time, smoking fewer CPD (cigarettes per day), greater reduction in dependence, and more cigarette-free days. However, the immediate reduction in nicotine caused greater withdrawal symptoms, greater use of nonstudy cigarettes, and higher drop-out rates. | *In this study, compared with gradual nicotine reduction, immediate reduction was associated with lower toxicant exposure across time, smoking fewer CPD (cigarettes per day), greater reduction in dependence, and more cigarette-free days. However, the immediate reduction in nicotine caused greater withdrawal symptoms, greater use of nonstudy cigarettes, and higher drop-out rates. | ||
===2017: [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5831363/ A review of the effects of very low nicotine content cigarettes on behavioral and cognitive performance]=== | |||
*The results from this review suggest that smoking VLNC cigarettes may fail to reverse withdrawal-induced disruptions in performance following complete smoking abstinence or reduced nicotine exposure. Of the 19 studies reviewed herein, 15 reported significant differences in performance when smokers smoked VLNC versus NNC cigarettes. All results were in the direction of performance being worse when participants smoked VLNC relative to NNC cigarettes. | |||
*It is important to underscore the evidence suggesting that combined NRT and VLNC cigarettes restore disrupted performance when smoking VLNC cigarettes alone does not. Thus, if a reduced nicotine content policy was adopted, supplemental use of NRT and likely other non-combustible forms of nicotine (e.g., e-cigarettes) would be a viable option for protecting against the type of performance disruptions revealed in this review, although a larger number of studies directly examining this matter would be helpful. | |||
| Line 60: | Line 108: | ||
===2017: [https://pubmed.ncbi.nlm.nih.gov/28214392/ Reduced nicotine content cigarette advertising: How false beliefs and subjective ratings affect smoking behavior]=== | ===2017: [https://pubmed.ncbi.nlm.nih.gov/28214392/ Reduced nicotine content cigarette advertising: How false beliefs and subjective ratings affect smoking behavior]=== | ||
*Smokers may misconstrue RNC cigarettes as less harmful than regular cigarettes. These beliefs, in conjunction with favorable subjective ratings, may increase product use. | *Smokers may misconstrue RNC cigarettes as less harmful than regular cigarettes. These beliefs, in conjunction with favorable subjective ratings, may increase product use. | ||
===2015: [https://cebp.aacrjournals.org/content/24/2/331 Biochemical Estimation of Noncompliance with Smoking of Very Low Nicotine Content Cigarettes]=== | |||
*Biomarker analysis demonstrates a high degree of noncompliance with smoking VLNC cigarettes, indicating that smokers are supplementing these with conventional cigarettes. | |||
===2015: [https://www.nejm.org/doi/full/10.1056/NEJMsa1502403 Randomized Trial of Reduced-Nicotine Standards for Cigarettes]=== | ===2015: [https://www.nejm.org/doi/full/10.1056/NEJMsa1502403 Randomized Trial of Reduced-Nicotine Standards for Cigarettes]=== | ||
*In this 6-week study, reduced-nicotine cigarettes versus standard-nicotine cigarettes reduced nicotine exposure and dependence and the number of cigarettes smoked. | *In this 6-week study, reduced-nicotine cigarettes versus standard-nicotine cigarettes reduced nicotine exposure and dependence and the number of cigarettes smoked. | ||
===2015: [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4565734/ Effect of Reducing the Nicotine Content of Cigarettes on Cigarette Smoking Behavior and Tobacco Smoke Toxicant Exposure: Two Year Follow Up]=== | |||
*During the 12 months follow-up, cotinine levels in RNC smokers rose to baseline levels and to those of control smokers. Quit rates among RNC smokers were very low (7.5% vs 3 % in controls, N.S.). | |||
*Article: [https://www.ucsf.edu/news/2015/07/131046/low-nicotine-cigarettes-fail-sway-smokers Low-Nicotine Cigarettes Fail to Sway Smokers] | |||
**Study Finds Effectiveness of Cessation Aid Slips After 6 Months | |||
<br> | |||
===2013: [https://pubmed.ncbi.nlm.nih.gov/23603206/ Reduced nicotine content cigarettes and nicotine patch]=== | ===2013: [https://pubmed.ncbi.nlm.nih.gov/23603206/ Reduced nicotine content cigarettes and nicotine patch]=== | ||
| Line 79: | Line 138: | ||
===2009: [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2573966/ | ===2009: [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2573966/ Toxicological Analysis of Low-Nicotine and Nicotine-Free Cigarettes]=== | ||
*In summary, a toxicological analysis does not indicate that low-nicotine and nicotine-free Quest® cigarettes have less adverse toxicological effects in the laboratory than conventional cigarettes. This should draw the attention of the consumers and policy makers. A more comprehensive evaluation in smokers is expected for these new products. | *In summary, a toxicological analysis does not indicate that low-nicotine and nicotine-free Quest® cigarettes have less adverse toxicological effects in the laboratory than conventional cigarettes. This should draw the attention of the consumers and policy makers. A more comprehensive evaluation in smokers is expected for these new products. | ||
==Statements, Official Comments, Testimony== | |||
===2018: [https://www.iowaattorneygeneral.gov/media/cms/Reduced_Nicotine_ANPRM_Response_180_5BB91F8E318CC.pdf ANPRM comment by Iowa AG, Tom Miller, and leading public health experts]=== | |||
*However, we all agree that there is one important requirement common to each of the perspectives above: that is the availability of low-risk non-combustible alternative tobacco or nicotine products that are sufficiently satisfying alternatives to cigarettes that smokers who choose to continue to use nicotine would be willing to switch to them. | |||
==Discussion links BLOGs, Articles, Videos, etc== | ==Discussion links BLOGs, Articles, Videos, etc== | ||
===2022: [https://tobaccoreporter.com/2022/06/21/policy-masterstroke-or-political-quagmire/ Policy masterstroke or political quagmire?]=== | |||
===2021: [https://clivebates.com/fda-spreads-confusion-about-nicotine-and-smoking/ FDA spreads confusion about nicotine and smoking]=== | |||
| Line 92: | Line 164: | ||
===2021: [https://filtermag.org/new-zealand-smokefree-prohibition/ Desperate to Win the Smokefree Race, New Zealand Resorts to Prohibition]=== | ===2021: [https://filtermag.org/new-zealand-smokefree-prohibition/ Desperate to Win the Smokefree Race, New Zealand Resorts to Prohibition]=== | ||
===2021: [https://tobaccoreporter.com/2021/02/01/a-mixed-record/ A Mixed Record]=== | |||
| Line 101: | Line 176: | ||
===2017: [https://thehill.com/opinion/healthcare/353843-feds-should-think-twice-before-trying-to-reduce-nicotine-in-cigarettes Feds should think twice before trying to reduce nicotine in cigarettes]=== | ===2017: [https://thehill.com/opinion/healthcare/353843-feds-should-think-twice-before-trying-to-reduce-nicotine-in-cigarettes Feds should think twice before trying to reduce nicotine in cigarettes]=== | ||
<br> | |||
==Suggestions to add to this page== | |||
===2021: [https://pubmed.ncbi.nlm.nih.gov/34958368/ Predicting Non-Adherence With Very Low Nicotine Content Cigarettes Among Adults With Serious Mental Illness Who Smoke]=== | |||
===2020: [https://www.ingentaconnect.com/contentone/psp/hbpr/2020/00000007/00000006/art00004 Measuring Support for Requiring Reduced Nicotine Cigarettes: Issues with Questions, Answers, and Respondents]=== | |||
===2019: [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6939783/ Misperceptions of Nicotine and Nicotine Reduction: The Importance of Public Education to Maximize the Benefits of a Nicotine Reduction Standard]=== | |||
===2019: [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6939779/ Reducing Nicotine Without Misleading the Public: Descriptions of Cigarette Nicotine Level and Accuracy of Perceptions About Nicotine Content, Addictiveness, and Risk]=== | |||
===2019: [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6939759/ The Role of Compensation in Nicotine Reduction]=== | |||
* [https://www.aacr.org/patients-caregivers/progress-against-cancer/low-nicotine-cigarette-smokers-and-compensatory-smoking/#:~:text=The%20researchers%20found%20that%20there,Smith%20said “The data from this study are important because they suggest that smokers do not engage in compensatory smoking by smoking each cigarette more intensely when switching to low-nicotine cigarettes,”] | |||
===2018: [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5986583/ Effects of reduced nicotine content cigarettes on individual withdrawal symptoms over time and during abstinence]=== | |||
===2016: [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5328980/#FN1 U.S. adults' addiction and harm beliefs about nicotine and low nicotine cigarettes]=== | |||
===[https://www.xxiicentury.com/vln-clinical-studies/published-clinical-studies-on-very-low-nicotine-content-vlnc-cigarettes Studies on 22nd Century website]=== | |||
<br> | |||
[[Category:Safety info]] | |||
[[Category:Smoking cessation]] | |||
edits