Neal L Benowitz’s research while affiliated with University of California, San Francisco and other places

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Publications (975)


Differences in Combustible Cigarette Smoking-Related Biomarkers by Hormonal Contraceptive Use: An Exploratory Study
  • Article

January 2025

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5 Reads

Nicotine & Tobacco Research

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Qing Cao

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Lori G Stayer

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[...]

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Introduction Hormonal contraceptives (HCs), which contain synthetic forms of estrogen (i.e., ethinyl estradiol) and/or progesterone (i.e., progestin), are commonly used by women who smoke combustible cigarettes. Prior research has demonstrated that HCs containing ethinyl estradiol influence nicotine metabolism, though less is known about the role of progestins. We sought to examine the association between HC use and smoking-related biomarkers. Methods This exploratory secondary-data analysis included females, ages of 18-45, who currently smoked classified into three groups based on current HC use: (1) combination HCs (C-HC; contains ethinyl estradiol and progestin), (2) progestin-only HCs (P-HC; contains progestin only with no ethinyl estradiol), and (3) no use of hormonal contraceptives (no-HC; no current use of ethinyl estradiol nor progestins). Group differences in expired carbon monoxide, urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) (NNAL), nicotine metabolite ratio (NMR), total nicotine equivalent (TNE), and the ratio of TNE to cigarettes/day were assessed. Results The C-HC (n=22), P-HC (n=67), and no-HC (n=59) groups did not vary by age or race. Smoking-related biomarkers did not vary between the P-HC and no-HC groups. In adjusted analyses, the C-HC group had a lower TNE level (median=41.22, interquartile range [IQR]: 32.10, 60.93) versus the P-HC group (median=59.70, IQR=44.89, 83.19; adjusted p-value=0.006) and the no-HC group (median=65.90, IQR=57.55, 85.92; adjusted p-value=0.010). Conclusion Smoking-related biomarkers were comparable between those who used progestin-only hormonal contraceptives to those who did not use any hormonal contraceptive. In contrast, TNE varied in those who used hormonal contraceptives with ethinyl estradiol. Additional research is needed to replicate these observations. Implications This exploratory study is the first to examine combustible cigarette smoking-related biomarkers by use of hormonal contraceptives with and without ethinyl estradiol as compared to no hormonal contraceptive use. In brief, biomarkers in those using hormonal contraceptives without ethinyl estradiol (i.e., progestin-only) were comparable to biomarkers in those not using any hormonal contraceptives. In contrast, those using hormonal contraceptives with ethinyl estradiol had significantly lower total nicotine equivalent even after adjusting for race. These observations indicate that progestin-only hormonal contraceptives use may not alter smoking-related biomarkers whereas hormonal contraceptives with ethinyl estradiol may influence these biomarkers.


Nicotine levels in flavoured hookah (waterpipe) tobacco products: discrepancies between labelled and measured levels

January 2025

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5 Reads

Tobacco Control

Background Hookah tobacco smoking is prevalent among youth and young adults. While health warning labels play a critical role in communicating the health risks of tobacco product use to consumers, compliance with US Federal Regulation’s nicotine warning requirements on hookah tobacco packaging is low. Some labelling suggests that consumers are exposed to ‘only 0.05% nicotine’. Here, this study sought to evaluate the accuracy of nicotine levels advertised on flavoured hookah tobacco packaging. Methods We measured nicotine content of commercial hookah tobacco in a total of 15 flavours purchased from five different manufactures, that were selected based on their popularity in the USA and UK markets. Concentrations of nicotine were determined by gas–liquid chromatography with nitrogen phosphorus detection, using 5-methyl nicotine as an internal standard. Nicotine content was expressed as a percentage of tobacco weight. Results Out of the 15 flavours tested and as compared with nicotine levels advertised on product packaging (0.05% nicotine), 12 (80%) had higher nicotine levels. Of these 12 flavours, actual nicotine levels ranged between 20% and 160% higher (0.08±0.01% vs 0.05%; mean±SE) than advertised levels. Estimates of determined levels of nicotine ranged from 0.05% to 0.13%. Conclusion Nicotine levels cited by leading hookah tobacco manufacturers are misleading. The advertised levels of nicotine do not reflect the quantified dose of nicotine available to consumers of hookah tobacco products. Findings highlight the need for the development of hookah tobacco product regulations and labelling standards, similar to other tobacco products, to avoid misleading vulnerable consumers, including youth and young adults.


Impact of Smokeless Oral Nicotine Products on Cardiovascular Disease: Implications for Policy, Prevention, and Treatment: A Policy Statement From the American Heart Association

December 2024

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17 Reads

Circulation

Smokeless oral nicotine products are addictive, and their use has potential adverse effects on some but not all biomarkers of cardiovascular risk. The use of some types of these products, for instance, is associated with an increased mortality risk in those with ischemic heart or cerebrovascular disease. Similarly, smokeless tobacco has the potential to increase the risk of oral cancer, but the risks depend on the chemical composition of the product. The market of smokeless oral nicotine products has transformed since the last American Heart Association smokeless tobacco policy statement. Several varieties of tobacco-free oral nicotine products—including oral nicotine pouches; nontherapeutic nicotine gums, lozenges, and tablets; and nicotine gummies—have rapidly proliferated. The sales of oral nicotine pouches, in particular, have increased substantially; however, no data are available on their cardiovascular or health risks. In addition, synthetic (compared with tobacco-derived) nicotine has been used in some brands of oral nicotine products, but its cardiovascular and health effects have been inadequately studied. Robust public policy levers are identified to support ending addiction to all commercial tobacco products. Critical components and policy initiatives include clinicians emphasizing the prevention of tobacco product initiation and supporting cessation with established pharmacological and behavioral tobacco dependence treatment therapies as primary goals for achieving an end to commercial tobacco and nicotine addiction.


Overview of currently available nicotine products.
E-cigarettes, synthetic nicotine, heated-tobacco and smokeless nicotine delivery products: the nicotine landscape beyond combustible cigarettes
  • Literature Review
  • Full-text available

November 2024

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28 Reads

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1 Citation

Swiss medical weekly: official journal of the Swiss Society of Infectious Diseases, the Swiss Society of Internal Medicine, the Swiss Society of Pneumology

Cigarette smoking remains an enormous public health problem causing millions of preventable deaths annually worldwide. Although safe and efficient smoking cessation pharmacotherapies such as nicotine replacement products and the medications varenicline and bupropion are available, long-term abstinence rates remain low and new approaches to help smokers successfully quit smoking are needed. In recent years, electronic nicotine delivery systems such as e-cigarettes and heated-tobacco products, and novel smokeless nicotine delivery products like nicotine pouches have gained widespread popularity. These products can deliver nicotine without combustion of tobacco and might thus present an alternative to the currently available smoking cessation methods if they prove able to help smokers quit smoking conventional cigarettes while decreasing their exposure to toxicants. In this narrative review, we provide a summary of the characteristics of these novel nicotine delivery products and the available data regarding their efficacy as smoking cessation tools and safety profile with a focus on the current situation in Switzerland.

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Tobacco Biomarkers by Latino Heritage and Race, U.S., 2007-2014 National Health and Nutrition Examination Survey

September 2024

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5 Reads

Cancer Epidemiology Biomarkers & Prevention

Background Tobacco biomarkers reflect smoking intensity and are used to assess cessation status. No study has evaluated variation by Latino heritage. Methods Data from the 2007 to 2014 National Health and Nutrition Examination Survey were used to evaluate geometric mean concentrations of serum cotinine and urinary total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), stratified by smoking status and race and ethnicity, and ROC curves estimated values to distinguish smokers from nonsmokers by race and ethnicity and Latino heritage. Results The sample (n = 18,597) was 50.1% female, 16.6% Latino (58.6% Mexican, 10.4% Central American, 9.1% South American, 7.3% Puerto Rican, 3.5% Dominican, 2.7% Cuban, and 8.4% other Latinos, overall), 12.7% Black, and 70.7% White. Black nonsmokers and smokers had the highest cotinine concentrations (0.1 and 177.1 ng/mL), and among nonsmokers, Black individuals had the highest NNAL concentrations (1.4 pg/mL). Latino smokers had the lowest cotinine (32.7 ng/mL) and NNAL (63.9 pg/mL) concentrations. Among Latino smokers, Puerto Rican individuals had higher concentrations of cotinine (100.0 ng/mL) and NNAL (136.4 pg/mL). Cotinine levels defining smoking (Black: 9.1 ng/mL; Latino: 0.9 ng/mL; White: 3.8 ng/mL) and NNAL (Black: 24.1 pg/mL; Latino: 5.7 pg/mL; White: 15.5 pg/mL) varied. Puerto Rican adults (cotinine: 8.5 ng/mL; NNAL: 17.2 pg/mL) had higher levels than Central American (cotinine: 1.0 ng/mL, NNAL: 5.5 pg/mL) and Mexican (cotinine: 0.9 ng/mL, NNAL: 6.0 pg/mL) adults. Conclusions Cotinine and NNAL concentrations that define smoking differed by race and ethnicity and by heritage among Latinos, showing meaningful differences. Impact Cessation interventions with biomarker validation need to consider Latino heritage.




Reduced nicotine in cigarettes in a marketplace with alternative nicotine systems: randomized clinical trial

June 2024

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40 Reads

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6 Citations

The Lancet Regional Health - Americas

Background Reducing cigarette addictiveness has the potential to avert millions of yearly tobacco-related deaths worldwide. Substantially reducing nicotine in cigarettes decreases cigarette consumption, but no large clinical trial has determined the effects of reduced-nicotine cigarettes when other nicotine-containing products are available. The aim of this study was to examine the effects of reduced-nicotine cigarettes in the context of the availability of alternative nicotine delivery systems. Methods In a U.S. six-site, open-label, parallel-arm study, smokers were randomized for twelve weeks to an experimental marketplace containing cigarettes with either 0.4 mg or 15.8 mg nicotine per gram of tobacco; all had access to non-combusted alternative nicotine delivery systems (e.g., e-cigarettes; medicinal nicotine). Group differences in the primary outcomes (cigarettes per day, number of smoke-free days) were examined using linear and negative binomial regression, respectively (Trial Registration: NCT03272685). Findings Among 438 randomized participants (mean [standard deviation (SD), range] age, 44.5 [11.9, 20–73] years, 225 [51.4%] women, 282 [64.4%] White and 339 [77.4%] trial completers), those in the 0.4 mg vs. 15.8 mg nicotine cigarette condition experienced significantly lower cigarettes per day at the end of intervention (mean [SD], 7.05 [7.88] vs. 12.95 [9.07], adjusted mean difference, −6.21 [95% CI, −7.66 to −4.75], P < 0.0001) and greater smoke-free days during intervention (mean [SD], 18.59 [27.97] vs. 5.06 [13.77], adjusted rate ratio, 4.25 [95% CI, 2.58–6.98], P < 0.0001). Interpretation A reduced-nicotine cigarette standard in the context of access to other non-combusted nicotine products has the potential to benefit public health. Funding U.S. NIH/FDA U54DA03165.


Biochemically Confirmed Continuous E-Cigarette Abstinence by Treatment Group
Cytisinicline for Vaping Cessation in Adults Using Nicotine E-Cigarettes: The ORCA-V1 Randomized Clinical Trial

May 2024

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35 Reads

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11 Citations

JAMA Internal Medicine

Importance The prevalence of e-cigarette use among US adults, especially young adults, is rising. Many would like to quit vaping nicotine but are unable to do so. Cytisinicline, a plant-based alkaloid, targets nicotinic acetylcholine receptors, reduces nicotine dependence, and helps adults to stop smoking cigarettes. Cytisinicline may also help e-cigarette users to quit vaping. Objective To determine the efficacy and safety of cytisinicline vs placebo to produce abstinence from e-cigarette use in adults seeking to quit vaping nicotine. Design, Setting, and Participants This double-blind placebo-controlled randomized clinical trial compared 12 weeks of treatment with cytisinicline vs placebo, with follow-up to 16 weeks. It was conducted from July 2022 to February 2023 across 5 US clinical trial sites. A total of 160 adults who vaped nicotine daily, sought to quit, and did not currently smoke cigarettes were enrolled, and 131 (81.9%) completed the trial. Intervention Participants were randomized (2:1) to cytisinicline, 3 mg, taken 3 times daily (n = 107) or placebo (n = 53) for 12 weeks. All participants received weekly behavioral support. Main Outcomes and Measures Biochemically verified continuous e-cigarette abstinence during the last 4 weeks of treatment (weeks 9-12; primary outcome) and through 4 weeks posttreatment (weeks 9-16; secondary outcome). Missing outcomes were counted as nonabstinence. Results Of 160 randomized participants (mean [SD] age, 33.6 [11.1] years; 83 [51.9%] female), 115 (71.9%) formerly smoked (≥100 lifetime cigarettes). Continuous e-cigarette abstinence in cytisinicline and placebo groups occurred in 34 of 107 participants (31.8%) vs 8 of 53 participants (15.1%) (odds ratio, 2.64; 95% CI, 1.06-7.10; P = .04) at end of treatment (weeks 9-12) and in 25 of 107 participants (23.4%) vs 7 of 53 participants (13.2%) during weeks 9 to 16 (odds ratio, 2.00; 95% CI, 0.82-5.32; P = .15). There was no evidence, based on nonsignificant interactions, that cytisinicline efficacy differed in subgroups defined by demographic characteristics, vaping pattern, e-cigarette dependence, or smoking history. Cytisinicline was well tolerated, with 4 participants (3.8%) discontinuing cytisinicline due to an adverse event. Conclusions and Relevance In this randomized clinical trial, cytisinicline for 12 weeks, with behavioral support, demonstrated efficacy for cessation of e-cigarette use at end of treatment and was well tolerated by adults, offering a potential pharmacotherapy option for treating nicotine e-cigarette use in adults who seek to quit vaping. These results need confirmation in a larger trial with longer follow-up. Trial Registration ClinicalTrials.gov Identifier: NCT05431387



Citations (75)


... Tobacco companies offer products that deliver nicotine without burning tobacco (heated tobacco, snus, nicotine pearls and pouchs), promising an alternative to traditional cigarettes. These products may reduce the harmful effects associated with smoke inhalation (lung cancer, COPD), but they maintain nicotine dependence, they are not free of toxicity and therefore not credible proposals [31]. ...

Reference:

Tobacco Pandemic: Challenges and Responses
E-cigarettes, synthetic nicotine, heated-tobacco and smokeless nicotine delivery products: the nicotine landscape beyond combustible cigarettes

Swiss medical weekly: official journal of the Swiss Society of Infectious Diseases, the Swiss Society of Internal Medicine, the Swiss Society of Pneumology

... Such limits have the potential to weaken the impact of a nicotine-reduction policy on adults, especially those with comorbid psychiatric conditions or socioeconomic disadvantage who are likely to have greater difficulty quitting nicotine use. 16,17 Preliminary studies in the general population suggest that e-cigarettes in commonly preferred flavors enhance VLNC smoking reductions, although the concurrent availability of other alternative tobacco products 18,19 and small sample size 20 in those studies precluded firm conclusions. The present RCTs aimed to compare reductions in smoking achieved in adults with psychiatric conditions or lower educational level using VLNC cigarettes alone; combined with e-cigarettes limited to tobacco flavor (only flavor with FDA marketing approval at study initiation); or combined with e-cigarettes in 3 participantpreferred flavors selected from 8 flavors, including fruity and sweet. ...

Reduced nicotine in cigarettes in a marketplace with alternative nicotine systems: randomized clinical trial

The Lancet Regional Health - Americas

... Sadece esigara kullanan 160 bireyden oluşan çok merkezli bir çalışmada ise; günde iki kez 3 mg sitiziniklin alan katılımcıların, plasebo alanlara kıyasla, 9-12 hafta arasında daha yüksek oranda uzak kalabildikleri belirlenmiştir (%32 vs.%15; OR:2.64; %95 GA:1.06-7.10) (112). Yine kontrollere kıyasla, kombine NRT (bant ve pastiller) ile e-sigarayı bırakma oranı daha yüksek bulunmuş ancak sonuçlar istatistiksel açıdan önemli bulunmamıştır (113) Aerosollü sigaraları bırakmaya rehberlik edecek net verilerin olmaması nedeniyle, genellikle sigarayı bırakmada etkili olduğu bilinen davranışsal veya farmakolojik stratejiler benimsenmektedir. ...

Cytisinicline for Vaping Cessation in Adults Using Nicotine E-Cigarettes: The ORCA-V1 Randomized Clinical Trial

JAMA Internal Medicine

... cessação ao tabagismo(CHRISTEN SE, et al., 2024). A eficácia dos CEs em suprimir os sintomas de abstinência de nicotina varia conforme a potência do dispositivo, a concentração de nicotina e a experiência do usuário, além de replicar aspectos sensoriais do tabagismo, como o movimento da mão à boca e o "golpe na garganta"(SCHIEK H, et al., 2024). ...

Pharmacokinetics and Pharmacodynamics of Inhaled Nicotine Salt and Free-Base Using an E-cigarette: A Randomized Crossover Study

Nicotine & Tobacco Research

... Dai and colleagues analyzed biospecimen data from the Population Assessment of Tobacco and Health Study (2013-2019) and found that compared with people who do not use tobacco, people who exclusively use premium cigars had higher biomarkers of exposure for cotinine, tobacco-specific nitrosamine (TSNA), and volatile organic compounds; however, they also had lower biomarkers of exposure than those who exclusively smoke cigarillos, filtered cigars, and cigarettes. 29 Using data on cigar retailers from the Premium Cigar Association, Amanda Kong and colleagues examined the store types of brick-and-mortar premium cigar retailers across the country and found that one in five retailers was a cigar bar or lounge, where products can be consumed on-site. 30 Given the biomarker of exposure data, 29 these studies raise public health concerns around exposure to consumers as well as to secondhand smoke for patrons and employees. ...

Biomarkers of Toxic Exposure and Oxidative Stress Among U.S. Adult Users of Premium Cigar Versus Other Cigar Subtypes: 2013–2019

Nicotine & Tobacco Research

... Recent studies assessed the efficacy and safety of different CYT dosing regimens. A placebo-controlled randomized clinical trial introduced a pharmacokinetically based CYT dosing regimen for 6 or 12 weeks with significant efficacy and safety in treating tobacco addiction [59]. Other recent observational studies assessed a 40-days CYT treatment (with an induction phase and a slower reduction schedule) with promising results in terms of efficacy rate and safety profile [60,61]. ...

Cytisinicline for Smoking Cessation: A Randomized Clinical Trial
  • Citing Article
  • July 2023

JAMA The Journal of the American Medical Association

... Thirdhand smoke (THS) pollution is the chemical residue of secondhand smoke (SHS) found in dust, on surfaces, and embedded in furniture and building materials that persists long after active indoor smoking by former occupants has ceased. 1 THS is often unnoticed and has been found in nonsmokers' homes who have moved into homes previously occupied by smokers 2,3 or who live in attached housing units in which tobacco smoking is actively occurring or has occurred in the past. 1,4,5 THS also remains present in homes of smokers after they quit. ...

Policy-relevant differences between secondhand and thirdhand smoke: strengthening protections from involuntary exposure to tobacco smoke pollutants

Tobacco Control

... In contrast to our findings, other evidence suggests that nontobacco flavors, specifically sweet (Baker et al., 2021;Bremmer et al., 2024;Kim et al., 2016) and menthol (DeVito et al., 2020;Litt et al., 2016) flavors, increase the appeal of ECs to adult smokers compared to tobacco flavor. Consistent with our product use findings and with another study (Giberson et al., 2023), we found no impact of EC nicotine concentration on TNE. ...

Nicotine Intake in Adult Pod E-Cigarette Users: Impact of User and Device Characteristics
  • Citing Article
  • April 2023

Nicotine & Tobacco Research

... Both are included in the PhenX Toolkit catalog of expert-recommended protocols [6]; see (1) "Biomarker of exposure to nicotine-containing products" in the Respiratory Domain for cotinine as measured in saliva, serum, or urine, and (2) "Expired Carbon Monoxide" in the Tobacco Regulatory Research Collection. Additional biomarkers, some of which are routinely used by the research community, are useful in predicting smoking status, as reviewed by Bierut et al. [7]. DNAm assessments of blood or saliva may offer yet another valuable method for determining smoking status and smoking cessation in research and clinical settings. ...

Working Title: Smoking Cessation, Harm Reduction, and Biomarkers Protocols in the PhenX Toolkit: Tools for Standardized Data Collection
  • Citing Article
  • April 2023

Addiction Neuroscience

... However, to date, studies directly assessing related cancer risk after in utero exposure in human fetuses are nonexistent. Recent studies showed that exposure to thirdhand smoke exposures from traditional cigarette use can alter body weight and immunity, and lead to lung cancer development in mice [120] . One key factor is genetic susceptibility to various forms of cancer, as has been demonstrated in different mouse strains [121] . ...

Thirdhand tobacco smoke exposure increases the genetic background-dependent risk of pan tumor development in Collaborative Cross mice

Environment International