Nicotine Replacement Therapy Products Research Articles

A qualitative study of using nicotine products for smoking cessation after discharge from residential drug and alcohol treatment in Australia.

Tobacco smoking is highly prevalent among alcohol and other drugs (AOD) service clients and, despite interest in quitting, abstinence is rarely sustained. Nicotine products may assist after discharge from residential treatment services, but little is known about client receptivity to them. This study examined AOD withdrawal service clients' experiences of two types of nicotine products for smoking cessation post-discharge, combination nicotine replacement therapy (cNRT) and nicotine vaping products (NVP). We held semi-structured telephone interviews with 31 Australian AOD service clients in a clinical trial of a 12-week smoking cessation intervention using Quitline support plus cNRT or NVP delivered post-discharge from a smoke-free residential service. We asked about health and social factors, nicotine cravings, Quitline experience, and barriers and facilitators to cNRT or NVP, then thematically analysed data. cNRT and NVP were described by participants as feasible and acceptable for smoking cessation. For most participants, cost limited cNRT access post study, as did difficulty navigating NVP prescription access. Quitline support was valued, but not consistently used, with participants noting low assistance with NVP-facilitated cessation. Participants considered both cessation methods acceptable and socially supported, and sought information on decreasing nicotine use via NVP. AOD service clients highly valued receiving cNRT or NVP with behavioural support for smoking reduction or abstinence. Both interventions were acceptable to service clients. Findings suggest a potential need to examine both whether NVP use should be permitted in this context, and guidance on the individual suitability of cNRT or NVP.

Impact of Nicotine Replacement Therapy Sampling on Cessation-Related Processes.

Smoking prevalence remains high among low-income smokers. Understanding processes (eg, withdrawal, craving, motivation) in early smoking cessation is crucially important for designing effective interventions for this population. This is a secondary analysis of a novel, in-session sampling intervention (ie, In Vivo) as compared with standard care behavioral smoking cessation counseling (SC) among community-dwelling low-income smokers (n = 83). This analysis examined the effect of 5 in-session sampling interventions on cessation-related processes and perceived advantages or disadvantages of nicotine replacement therapy (NRT) products over time using daily diaries. The In Vivo treatment had an early positive impact in terms of decreasing withdrawal symptoms and cravings, and increasing perceived advantages to NRT, with moderate to large effect sizes. Results also showed that the treatment effectively reduced withdrawal symptoms and cravings in-session, with small-to-medium and medium-to-large effect sizes, respectively. In-session reduction of withdrawal symptoms and cravings did not occur for the SC group, with the exception of decreased withdrawal symptoms occurring during week 4. The In Vivo treatment did not impact quit goal, desire to quit, abstinence self-efficacy, perceived difficulty in quitting, motivational engagement, or perceived disadvantages to NRT. The In Vivo group reported less daily cigarette use relative to the SC group, in addition to reporting less cigarette use on days they reported greater combination NRT use. There is preliminary support for this In Vivo treatment over SC in reducing withdrawal, craving, and the number of cigarettes smoked per day, as well as promoting perceived advantages of NRT among low-income smokers.

Predictors of Nicotine Replacement Therapy Adherence: Mixed-Methods Research With a Convergent Parallel Design.

Few studies have examined the effect of baseline attitudes toward nicotine replacement therapy (NRT) on its actual adherence in a smoking cessation intervention. This study (i) examined the predictability of baseline variables (quantitative data) on NRT adherence and (ii) explored the congruence of participants' statements about NRT products (qualitative data) during counseling sessions with their baseline attitudes. This is a mixed-methods research study using a convergent parallel design. Participants included 74 individuals in the treatment group who received behavioral counseling and combination NRT. A Poisson regression analysis was performed to identify baseline variables predicting NRT adherence. Thematic analysis was completed with a subset of participants (n = 38) who varied in NRT attitude scores and adherence. A joint display was created to integrate quantitative and qualitative data and discover convergence. Approximately 59% of the participants (41/74) used NRT continuously for ≥5 weeks. Having negative attitudes toward NRT and depressive symptoms predicted NRT adherence even after controlling for education and anxiety symptoms. Thematic analysis revealed that NRT adherence is a learning process that consists of the following three distinctive but interrelated phases: (i) information needs, (ii) comprehensive readiness, and (iii) experiential learning. Of the 38 participants, 34 (89.5%) showed convergence between baseline attitude scores and statements about NRT made during counseling sessions. Individuals who have negative attitudes toward NRT are less likely to use the products in a smoking cessation intervention. Counselors should assess attitudes toward NRT at baseline and address them proactively during counseling sessions.

Literature Review on Nicotine’s Role in Human Health

Summary Background Next generation of nicotine/tobacco products (NGPs) include electronic cigarettes (ECs), heated tobacco products (HTPs), oral nicotine pouches (NPs) and smokeless tobacco (SLT) products (in particular snus). These products commonly contain nicotine and are intended to replace combustible cigarettes (CCs) and thus can be regarded as tobacco harm reduction products. To fulfill this role, it is essential that nicotine, which has well established addictive properties, is not causally related to health risks upon chronic use. Objectives The purpose of this review is to evaluate the scientific literature to answer the question, whether nicotine is involved in the development of any diseases or disorders associated with the acute, short, mid- and long-term use of NGPs. Appropriate results from studies with nicotine replacement therapy (NRT) products (gum, patches, inhalers, lozenges) are included as reference basis for inferring the health effects of NGPs. Furthermore, suggestions for filling identified gaps and for avoiding or minimizing limitations and weaknesses in study design are provided. Methods Literature databases such as MEDLINE, Google Scholar and an in-house ABF library (containing about 180,000 articles) were searched for relevant articles. Furthermore, pertinent monographs (such as the US Surgeon General Reports) and recent reviews were screened for further publications. Inclusion criteria were: all human studies investigating the association between use (preferably chronic use) of the nicotine/tobacco products mentioned above and health effects, including diseases, disorders, changes in biomarkers of biological effect (BOBEs). In vivo (animal) and in vitro studies were also considered, provided effects of NGPs in the presence and absence of nicotine or in relation to the nicotine exposure dose were reported. Also, reference lists of recent suitable articles were screened. In total, about 500 articles were retrieved by this approach. The role of nicotine was evaluated by considering the article authors’ statements and their cited references as well as by own judgement of reported results. Human studies are presented in a standardized table format. Results In total, 183 human studies were evaluated, with cardiovascular diseases (CVD) ranking highest (N = 75 studies), followed by respiratory diseases (43), oral health disorders (23), cancer (10), metabolic syndrome (7), reproduction disorders (5) and several other diseases (< 5). The majority of studies do not provide evidence for a participation of nicotine in the pathogenesis. Some (weak) evidence was found that nicotine might be involved in some CVD-related effects and metabolic syndrome. This would be also supported by results from animal and in vitro studies. Discussion Human studies showed some severe limitations and weaknesses with respect to the study design and time of availability of NGPs on the market. A severe flaw is the insufficient consideration of dual use (NGP + CC), particularly in studies on chronic use, which could have led to erroneously increased risks for NGPs with direct consequences also for the role of nicotine. Additionally, prior effects from using CC have an impact. Both circumstances could have led to inaccurate conclusions in terms of elevated risk levels, which require changes in method designs. Suggestions for methodological improvements are provided for future studies. Conclusions A final evaluation of the role of nicotine in disease development in NGP users is currently not possible because use durations are too short. Chronic studies often suffer from insufficient separation between NGP only and dual use together with CCs, which may falsely increase the observed health risk. There is some limited evidence that nicotine may be involved in CVD-related effects, which, however, has to be verified in well controlled long-term studies. The potential involvement of nicotine in other patho-mechanisms also requires further research.

Type-switching of short-acting nicotine replacement therapy products and its implications for treatment

IntroductionThe frequency with which people change from one medical treatment to another partly reflects satisfaction with the initial intervention. In this secondary analysis of observational data, we explore switch rates for short-acting nicotine replacement therapy (NRT) products, which differ in mode of use, rapidity of action, and adverse effect profiles. MethodsWe analyzed data from 46,882 participants in the Smoking Treatment for Ontario Patients program who received short-acting NRT (gum, lozenge, oral spray, or inhaler) at their initial visit. We used discrete-time survival analysis to model the time elapsing before a change was made to another product and included time-by-product interactions to explore differences over time and product-by-previous-quit-attempts interactions to examine the importance of potential previous exposure to NRT. We adjusted both models for a range of sociodemographic and tobacco use variables. ResultsOverall, 37.9% (95% CI = 37.5%, 38.4%) of participants switched to a different product at their first follow-up visit. Time-averaged and adjusted switch probabilities were 21.1% for gum, 23.8% for lozenge, 26.0% for inhaler, and 28.8% for oral spray. Switch rates were highest for people without past quit attempts, for women, and for people also using the nicotine patch. ConclusionsPeople frequently switch from one type of short-acting NRT to another. We did not assess reasons for switching, but they may include adverse effects, impracticality, and perceived ineffectiveness. Given the superior effectiveness of combination treatment, making multiple products available may improve outcomes by allowing some people to continue with short-acting products for longer.

Is hospitalization a missed opportunity to intervene on tobacco cessation?

BackgroundAlthough tobacco use is associated with elevated morbidity and mortality, its use remains widespread among adults within the United States. Nicotine Replacement Therapy (NRT) products are effective aids that improve rates of tobacco cessation. Many smokers interact with the medical system, such as during hospitalization, without their tobacco use addressed. Hospitalization is a teachable moment for patients to make health-related changes, including tobacco cessation. MethodsRetrospective cohort study of adult patients in a university-based patient-centered medical home from 2012 to 2021 evaluating the proportion of adults who smoke who received at least one prescription for NRT. Logistic regression models were used to analyze the association of being hospitalized and receipt of a NRT prescription. ResultsOf the 4,072 current smokers identified, 1,182 (29%) received at least one prescription for NRT during the study period. Hospitalization was associated with increased odds of receiving a NRT prescription (OR 1.68). Of 1,844 current smokers with a hospitalization during the study period, 1,078 (58%) never received a prescription for NRT at any point. Only 87 (5%) of the smokers received a prescription for NRT during hospitalization or at the time of hospital discharge. ConclusionsDespite hospitalization being associated with NRT prescribing, most patients who use tobacco and are hospitalized are not prescribed NRT. Hospitalization is an underutilized opportunity for both hospitalists and primary care physicians to intervene on smoking cessation through education and prescription of tobacco cessation aids.

Changes in Sales of Tobacco and Nicotine Replacement Therapy Products Before and During the COVID-19 Pandemic.

The COVID-19 pandemic and its associated social distancing policies such as lockdowns and quarantine influenced people's lives and health behaviors. We comprehensively assessed national trends in sales of cigarettes, cigars, e-cigarettes, and over-the-counter nicotine replacement therapy (NRT) products before and during the pandemic, allowing for cross-product comparisons. Stockpiling behavior was also assessed. We used US national tobacco and over-the-counter NRT retail store scanner data (excluding internet, specialty/vape store, and prescription sales) collected at 4-week intervals by NielsenIQ from December 2018 to June 2021. We applied an interrupted time-series model to assess differences in tobacco product and NRT unit sales before and during the pandemic. We defined the prepandemic period as December 16, 2018, through April 4, 2020, pandemic as starting on April 5, 2020, through June 26, 2021, and the stockpiling period as one 4-week period before the pandemic started. Four-week cigarette, e-cigarette, and cigar unit sales on average increased by 11.5% (P = .006), 37.1% (P < .001), and 26.1% (P < .001) respectively, while 4-week NRT unit sales decreased on average by 13.1% (P < .001), during the pandemic compared with the prepandemic period. Stockpiling was associated with increases in sales of all tobacco products and NRT products. Unit sales of assessed tobacco products increased while NRT unit sales decreased during the COVID-19 pandemic, compared with the prepandemic period. These changes may suggest an increase in the intensity of tobacco product use or stockpiling of tobacco products among people who use tobacco.

Effect of the Nicotine Replacement Therapy on Biomarkers of Inflammation, Endothelial Dysfunction, Oxidative Stress, and Lipids in Smokers Who Quit Smoking.

Our previous study showed major changes in biomarkers on quitting compared to the smoking state. They reflected a decrease in inflammation, endothelial activation, and oxidative stress, as well as an improved lipid profile. Nicotine replacement therapy (NRT) is effective to increase the rate of successful quitting, but healthcare professionals may have concerns to prescribe this first-line smoking cessation treatment because its effect on inflammation and related processes is controversial. The present study assessed the influence of NRT on biomarkers of inflammation, endothelial function, oxidative stress, and lipids, in people who quit smoking. Sixty-five subjects who daily smoke cigarettes were recruited and followed on quitting. Thirty-five quit using NRT and thirty quit without NRT. Biomarkers of inflammation, endothelial function, oxidative stress, and lipids were quantified at baseline when actively smoking and after cessation in the presence of NRT or not. Changes in biomarkers on quitting did not differ according to the treatment used. No difference was found when comparing participants who were exposed to NRT and those who were not. These results may indicate that NRT has no effect on inflammation, endothelial function, oxidative stress, and lipids, when used as a medication aid for quitting smoking. This study provides new evidence to support the safety profile of NRT products regarding the biomarkers of endothelial function, oxidative stress, inflammation, and lipids.

How do Smokers in a Snus-Prevalent Society Consider E-cigarettes, Snus, and Nicotine Replacement Therapy Products as Relevant Replacements for Cigarettes in the Event They Should Stop Smoking?

Around 50 percent of the tobacco in Norway is consumed in the form of snus, a smokeless oral tobacco. We examined Norwegian smokers' openness, and thereby the potential reach, to use e-cigarettes, nicotine replacement therapy products (NRT), and snus in the event of quitting smoking, in a society where snus use is common. Using data from an online survey of 4073 smokers from 2019 to 2021, we calculated predicted probabilities of smokers' being open, undecided, and not open to use e-cigarettes, snus, and NRT in the event they should quit smoking. Among daily smokers, the probability of being open to use e-cigarettes in the event of quitting smoking was .32. The corresponding probabilities for using snus and NRT were .22 and .19. Snus was the product with the highest probability of not being open (.60). NRT had the highest probability of being undecided (.39). Among smokers who had never used e-cigarettes or snus, the probabilities of being open were .13 for e-cigarettes, .02 for snus and .11 for NRT. In a snus-friendly norm climate where smokers have traditionally used snus as an alternative to cigarettes, the probability of using e-cigarettes in the event of smoking cessation was higher compared to both snus and NRT. However, among smokers who had never used e-cigarettes or snus, the likelihood of being open to use of NRT was similar to e-cigarettes, and higher than snus, which suggests that NRT may still play a role in smoking cessation. In a snus-prevalent country in the endgame phase of the cigarette epidemic, where robust infrastructure for tobacco control in combination with the availability of snus has reduced smoking to a minimum, the remaining smokers seem to prefer e-cigarettes to snus if they should quit smoking. This indicates that availability of several nicotine alternatives might increase the likelihood of a future product replacement within the small group of remaining smokers.

Increased Nicotine Consumption in Australia During the First Months of the COVID-19 Pandemic.

Mixed findings have been reported about the impact of the COVID-19 pandemic on smoking behavior in different populations. In this study, we aimed to quantify changes in smoking prevalence through the proxy of nicotine consumption in the Australian population from 2017 to 2020 inclusive. Estimates of nicotine consumption between 2017 and 2020 were retrieved from a national wastewater monitoring program that covers up to 50% of the Australian population. National sales data for nicotine replacement therapy (NRT) products from 2017 to 2020 were also acquired. Linear regression and pairwise comparison were conducted to identify data trends and to test differences between time periods. The average consumption of nicotine in Australia decreased between 2017 and 2019 but increased in 2020. Estimated consumption in the first half of 2020 was significantly higher (~30%) than the previous period. Sales of NRT products increased gradually from 2017 to 2020 although sales in the first half of the year were consistently lower than in the second half. Total nicotine consumption increased in Australia during the early stage of the pandemic in 2020. Increased nicotine consumption may be due to people managing higher stress levels, such as from loneliness due to control measures, and also greater opportunities to smoke/vape while working from home and during lockdowns in the early stage of the pandemic. Tobacco and nicotine consumption have been decreasing in Australia but the COVID-19 pandemic may have temporarily disrupted this trend. In 2020, the higher impacts of lockdowns and working from home arrangements may have led to a temporary reversal of the previous downward trend in smoking during the early stage of the pandemic.

Harmful and potentially harmful constituents (HPHCs) in two novel nicotine pouch products in comparison with regular smokeless tobacco products and pharmaceutical nicotine replacement therapy products (NRTs)

BackgroundTobacco-free nicotine pouches is a novel category of oral nicotine-delivery products. Among current tobacco users such pouches may serve as a low-risk alternative to cigarettes or conventional, tobacco-based oral products e.g., snus and moist snuff. In the United States (U.S.), the market leading nicotine-pouch brand is ZYN®. However, no data on the chemical characteristics of ZYN have been published.MethodsWe screened for 43 compounds potentially present in tobacco products in seven oral nicotine-delivery products: ZYN (dry and moist), snus (General®), moist snuff (CRP2.1 and Grizzly Pouches Wintergreen), and two pharmaceutical, nicotine replacement therapy products (NRTs, Nicorette® lozenge and Nicotinell® gum). Thirty-six of the tested compounds are classified as harmful and potentially harmful constituents (HPHCs) by the Center for Tobacco Products at the U.S. Food and Drug Administration (FDA-CTP). Five additional compounds were included to cover the GOTHIATEK® product standard for Swedish snus and the last two compounds were chosen to include the four primary tobacco specific nitrosamines (TSNAs).ResultsThe tested products contained nicotine at varying levels. The two ZYN products contained no nitrosamines or polycyclic aromatic hydrocarbons (PAHs) but low levels of ammonia, chromium, formaldehyde, and nickel. In the NRT products we quantified low levels of acetaldehyde, ammonia, cadmium, chromium, lead, nickel, uranium-235, and uranium-238. The largest number (27) and generally the highest levels of HPHCs were quantified in the moist snuff products. For example, they contained six out of seven tested PAHs, and seven out of ten nitrosamines (including NNN and NNK). A total of 19 compounds, none of which were PAHs, were quantified at low levels in the snus product. NNN and NNK levels were five to 12-fold lower in snus compared to the moist snuff products.ConclusionsNo nitrosamines or PAHs were quantified in the ZYN and NRT products. Overall, the number of quantified HPHCs were similar between ZYN and NRT products and found at low levels.

Community pharmacists' counseling regarding nicotine replacement therapy: A secret shopper study.

Nicotine replacement therapy (NRT) is a safe and effective non-prescription tobacco cessation treatment. While most community-based pharmacists periodically provide patient education regarding NRT, there is a gap in real-world evidence assessing the counseling provided. To assess community pharmacist counseling regarding NRT in a real-world setting. A cross-sectional secret shopper audit was conducted to collect data regarding NRT counseling from 120 community pharmacist encounters. Seventeen trained college of pharmacy students presented to community pharmacies using a standardized script asking about 1 of 3 common NRT products (patch, gum, and lozenge). Pharmacies were randomly selected from a list of all community pharmacies open to the public in Bexar County, Texas. A standardized assessment form was used to document product availability, counseling length, whether or not the 7 counseling points and 6 assessment questions that could help guide the pharmacist's counseling regarding NRT products were provided without prompting, and potential inaccuracy of any recommendations and counseling points. Descriptive statistics were calculated, and analysis of variance and Fisher's exact test were used to test for variation across site type and time of day. NRT was available for purchase without speaking to pharmacy staff in 99 of 120 (83%) pharmacies. The mean length of counseling was 136 (standard deviation= 91) seconds. The most common points discussed were recommended strength (72%), tapering schedule (58%), and assessment of the daily number of cigarettes smoked (56%). Forty-one (34%) pharmacists provided one or more potentially inaccurate counseling points, the most common being inaccurate tapering schedule (provided during 31 (26%) encounters). Only 15% of pharmacists referred auditors for additional help or recommended a follow-up. NRT was commonly accessible in community pharmacies outside of the pharmacy area. Opportunities for pharmacists to provide more complete and accurate information to better assist patients with safe and effective smoking cessation were identified.

Changes in Sales of E-Cigarettes, Cigarettes, and Nicotine Replacement Therapy Products Before, During, and After the EVALI Outbreak

In 2019, an outbreak of e-cigarette, or vaping, product use-associated lung injury (EVALI) occurred in the US. We used Nielsen retail sales data to assess trends in sales of e-cigarettes, cigarettes, and nicotine replacement therapy (NRT) products before, during, and after the EVALI outbreak. Monthly unit sales of e-cigarettes, cigarettes, and NRT products overall and by product type were assessed during January 2019 through June 2020 by using an interrupted time series model. Two time points were specified at the period ending July 13, 2019, and the period ending February 22, 2020, to partition before, during, and after the outbreak period. Sales trends by aggregated state-level EVALI case prevalence (low, medium, and high) were assessed to investigate interstate variations in changes of sales coinciding with the EVALI outbreak. Monthly e-cigarette sales increased 3.5% (P < .001) before the outbreak and decreased 3.1% (P < .001) during the outbreak, with no significant changes after the outbreak. Monthly cigarette sales increased 1.6% (P < .001) before the outbreak, decreased 1.8% (P < .001) during the outbreak, and increased 2.7% (P < .001) after the outbreak. NRT sales did not change significantly before or during the outbreak but decreased (2.8%, P = .01) after the outbreak. Sales trends by state-level EVALI case prevalence were similar to national-level sales trends. Cigarette and e-cigarette sales decreased during the EVALI outbreak, but no changes in overall NRT sales were observed until after the outbreak. Continued monitoring of tobacco sales data can provide insight into potential changes in use patterns and inform tobacco prevention and control efforts.

Tobacco use and risk of COVID-19 infection in the Finnish general population

Empirical evidence, primarily based on hospital-based or voluntary samples, suggests that current smokers have a lower risk of COVID-19 infection than never smokers. In this study, we used nationally representative data to examine the association between tobacco use and the risk of having a confirmed COVID-19 case. We explored several forms of tobacco use, contributing to separate the role of nicotine from smoking. We used data from 44,199 participants from three pooled national health surveys in Finland (FinSote 2018–2020). The primary outcome was a confirmed COVID-19 case. We examined current smoking, moist smokeless tobacco (snus), e-cigarettes with and without nicotine and nicotine replacement therapy products. Current daily smokers had a relative risk of 1.12 of a confirmed COVID-19 case (95% CI 0.65; 1.94) in fully adjusted models compared with never smokers. Current snus use was associated with a 68% higher risk of a confirmed COVID-19 case (RR 1.68, 95% CI 1.02; 2.75) than never users. We did not find conclusive evidence of associations between e-cigarettes with and without nicotine and nicotine replacement therapy products and the risk of confirmed COVID-19 cases. Our findings suggest that nicotine might not have a protective role in the risk of COVID-19 as previously hypothesized.

Assessment of the Exposure to Aromatic Amines in Users of Various Tobacco/Nicotine Products.

Aromatic amines such as ortho-toluidine (o-Tol), 2-aminonaphthalene (2-AN), and 4-aminobiphenyl (4-ABP) are human bladder carcinogens and occur at various workplaces, in ambient air, in food products, as well as in tobacco smoke. In a clinical study comprising a period of 74 h under confinement, we investigated the exposure to these three aromatic amines as well as to 3-aminobiphenyl (3-ABP) by measuring them in urine of habitual users of combustible cigarettes (CCs), electronic cigarettes (ECs), heated tobacco products (HTPs), oral tobacco (OT), and nicotine replacement therapy products (NRTs). Non-users (NU) of any tobacco/nicotine products served as (negative) control group. Smokers (CC) exhibited the highest levels for all four aromatic amines measured, significantly elevated compared to NU and non-CC users. Urinary levels in users of EC, HTP, NRT (mostly nicotine gum), and OT (mostly snus) were not significantly different from those in NU. Users of HTP showed slightly elevated urinary excretion levels of o-Tol, 3-ABP, and 4-ABP compared to some other non-CC groups. Dose markers such as daily consumption, urinary nicotine equivalents (Nequ), and plasma cotinine (CotP) were found to be consistently and significantly correlated with the excretion of aromatic amines for smokers (CC) only. Excretion levels of 3- and 4-ABP in smokers were significantly lower in the urine collected overnight compared to that collected during the day, which is just the opposite of what we observed for other biomarkers in this study. The possible reason for this observation is discussed. In conclusion, in contrast to smoking of CCs, the use of ECs, HTPs, nicotine gum, and oral tobacco was not observed to be associated with significant exposure to the aromatic amines o-Tol, 2-AN, 3-ABP, and 4-ABP. The observed slight increase in o-Tol, 3-ABP, and 4-ABP excretions in HTP users has to be verified in larger studies.

Comparison of urinary mercapturic acid excretions in users of various tobacco/nicotine products.

Urinary mercapturic acids (MAs) are detoxification products for electrophiles occurring in the human body. They are suitable biomarkers of exposure to directly acting electrophilic chemicals or to chemicals which generate the electrophile during its metabolism. We determined the urinary excretion of 19 MAs in habitual users of combustible cigarettes (CCs), electronic cigarettes (ECs), heated tobacco products (HTPs), oral tobacco (OT), and nicotine replacement therapy (NRT) products, and nonusers (NUs) of any tobacco/nicotine products. The 19 MAs are assumed to be physiologically formed primarily from 15 toxicants with three of them belonging to IARC Group 1 (human carcinogen), seven to Group 2A (probable human carcinogen), four to Group 2B (possible human carcinogen), and one to Group 3 (not classifiable as carcinogen). Smoking (CC) was found to be associated with significantly elevated exposure to ethylene oxide (or ethylene), 1,3-butadiene, benzene, dimethylformamide, acrolein, acrylamide, styrene, propylene oxide, acrylonitrile, crotonaldehyde, and isoprene compared with the other user groups and NU. Users of HTPs revealed slight elevation in the MAs related to acrolein, acrylamide, and crotonaldehyde compared with the other non-CC groups. Vaping (EC) was not found to be associated with any of the MAs studied. In conclusion, the determination of urinary MAs is a useful tool for assessing the exposure to toxicants (mainly potential carcinogens) in users of various tobacco/nicotine products. Our data also give cause to clarify the role of vaping (EC) in urinary excretion of DHPMA (precursor: glycidol).

Assessment of the exposure to polycyclic aromatic hydrocarbons in users of various tobacco/nicotine products by suitable urinary biomarkers.

Polycyclic aromatic hydrocarbons (PAHs) occur naturally (bitumen and oils) and are formed during all incomplete combustions of organic materials. PAH exposure sources are manifold and include specific workplaces, ambient air, various foodstuffs, tobacco smoke and some medications. At least four members of this class of chemicals have been classified as proven or probable human carcinogens. Assessment of the exposure to PAHs with suitable methods is of importance, particularly in users of new-generation tobacco/nicotine products, which are intended to replace combustible cigarettes (CCs), a major source of non-occupational exposure to PAHs. In a clinical study comprising a period of 74h under confinement, we investigated the exposure to naphthalene (Nap), fluorene (Flu), phenanthrene (Phe), pyrene (Pyr) and benzo[a]pyrene (BaP) by measuring urinary monohydroxy-PAH (OH-PAH) derived from these parent compounds in habitual users of CCs, electronic cigarettes (ECs), heated tobacco products (HTPs), oral tobacco (OT), and nicotine replacement therapy products (NRTs). Non-users (NU) of any tobacco/nicotine products served as (negative) control group. Smokers exhibited the highest levels for all PAH biomarkers measured, almost all of which were significantly different from the NU and user groups of all other products investigated. CC smokers were the only group which showed a significant relationship between almost all PAH biomarkers and dose markers such as daily consumption, urinary nicotine equivalents (Nequ) and plasma cotinine (CotP). The ratios in urinary OH-PAH between CC and all other groups were dependent on the biomarker and range from < 2 to > 10. These ratios could at least partly be explained by the enzymes involved, their region-selectivity and inducibility by smoking. In conclusion, cigarette smokers (CC) were the only group, which showed product use dependent exposure to PAHs, whereas users of EC, HTP, NRT and OT were not distinguishable from NU of any tobacco/nicotine products.

The implementation of a smoking cessation and alcohol abstinence intervention for people experiencing homelessness

BackgroundIn the United States, eighty percent of the adult homeless population smokes cigarettes compared to 15 percent of the general population. In 2017 Power to Quit 2 (PTQ2), a randomized clinical trial, was implemented in two urban homeless shelters in the Upper Midwest to address concurrent smoking cessation and alcohol treatment among people experiencing homelessness. A subset of this study population were interviewed to assess their experiences of study intervention. The objective of this study was to use participants’ experiences with the intervention to inform future implementation efforts of combined smoking cessation and alcohol abstinence interventions, guided by the Consolidated Framework for Implementation Research (CFIR).MethodsQualitative semi-structured interviews were conducted with 40 PTQ2 participants between 2016–2017 and analyzed in 2019. Interviews were audio-recorded, transcribed, and analyzed using a socially constructivist approach to grounded theory.ResultsParticipants described the PTQ2 intervention in positive terms. Participants valued the opportunity to obtain both counseling and nicotine-replacement therapy products (intervention characteristics) and described forming a bond with the PTQ2 staff and reliance on them for emotional support and encouragement (characteristics of individuals). However, the culture of alcohol use and cigarette smoking around the shelter environment presented a serious challenge (outer setting). The study setting and the multiple competing needs of participants were reported as the most challenging barriers to implementation (implementation process).ConclusionThere are unique challenges in addressing smoking cessation with people experiencing homelessness. For those in shelters there can be the difficulty of pro-smoking norms in and around the shelter itself. Considering pairing cessation with policy level interventions targeting smoke-free spaces, or pairing cessation with housing support efforts may be worthwhile.. Participants described a discord in their personal goals of reduction compared with the study goals of complete abstinence, which may pose a challenge to the ways in which success is defined for people experiencing homelessness.Trial registrationClinicaltrials.gov, NCT01932996, registered 08/30/2013.

PCR46 A Mixed-Methods Study Using Cognitive Debriefing to Assess the Content Validity of a New Health and Functioning Measure for Tobacco and/or Nicotine Product Users

To inform tobacco harm reduction strategies, a new consumer reported outcome measure (CROM) was developed to assess perceived Health and Functioning (H&F) among users of tobacco and/or nicotine products (TNP). This study assessed the face, content validity, and early measurement properties of the draft H&F CROM. Cognitive debriefing interviews were conducted in two waves in the UK and US with adult users of: cigarettes (n=20), e-cigarettes (n=20), heated tobacco products (IQOSTM) (n=20), smokeless tobacco products (n=10), and nicotine replacement therapy products (n=10). Participants completed the draft measure (195 items) electronically through a “think-aloud” process. Different response options were tested. Transcripts were analyzed thematically using Atlas.ti. Exploratory psychometric analysis was conducted by Rasch Measurement Theory (RMT) analysis. Expert panel meetings were held to inform result interpretation and updating the CROM after each wave. The participants generally endorsed the content of the CROM, while the interim analysis allowed for some early item and scale refinements. The RMT analysis largely supported the scales’ reliability, sample-to-scale targeting, and discrimination potential across the TNP user groups. Conceptual overlap between some items was identified through both qualitative and quantitative evidence. Mixed-methods evidence was used to guide the selection of response scale, e.g., severity difficulty or frequency that could better match the underlying concept of each scale, while the 7-day recall period was found to have less of a ceiling effect. This study provides early supporting evidence of the new H&F CROM’s content relevance, clarity, and ease of completion. It comprises ten scales (146 items) covering different health concepts (including oral, lung, and general health and breathing difficulty), appearance, bother with TNP smell, as well as different functioning concepts (including work, social, and well-being). A psychometric validation study is being conducted to inform the item content, scoring structure, and measurement properties of the CROM.

Effect of Tobacco Cessation Aids on Smoking Cessation and Duration of Abstinence : a French Population-Based Study

IntroductionAlthough smoking prevalence has been decreasing worldwide, sustained tobacco cessation remains a challenging goal for many smokers. Nicotine replacement therapy (NRT) products remain among the most widespread type of cessation tobacco aids, along with the more recently introduced electronic cigarette, the efficiency of which is still a matter of debate in the public health community.ObjectivesThis study aims to contribute to the ongoing discussion about effective ways of encouraging tobacco cessation and in particular evaluating the role of the two aforementioned tobacco cessation aids with regard to lasting smoking abstinence in real-life settings.MethodsThe study is based on the French 2017 Health Barometer, a cross-sectional survey conducted by Santé Publique France. Two distinct outcomes related to tobacco cessation were used: smoking status at 6 months follow-up (yes vs. no) and the duration of smoking abstinence. These two study outcomes were examined respectively among N1 = 2783 and N2 = 1824 participants. All results were weighted based on inclusion probability weights and controlled for propensity scores via overlap weighting (OW), which is appropriate when exposure groups are disparate.ResultsAfter adjusting on potential confounders, tobacco cessation at 6 months remains significantly associated with e-cigarette use (OR: 1.50 (1.12-1.99)) and e-cigarette use combined with NRT (OR:1.88 (1.15-3.07)). This association did not reach statistical significance in the long-term analysis, nor did the results of NRT use alone in both analyses.ConclusionsOverall, while electronic cigarette use alone and combined with NRT is associated with an increase in the likelihood of smoking cessation, the long-term effects are probably limited.DisclosureNo significant relationships.