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Objective: Despite the popularity of nicotine gum in Thailand, population pharmacokinetics of nicotine gum in the Thai population has not been investigated. This study aimed to develop a population pharmacokinetic (POPPK) model of nicotine and to quantify the effects of genetic and non-genetic factors to nicotine pharmacokinetics. Materials and Methods: Secondary data collected from a previous clinical trial assessing cytochrome P450 2A6 (CYP2A6) genotypes in Thai smokers was investigated. Eighteen participants who had received a single dose of 2 mg nicotine gum were included. Blood samples were collected before, at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4.5 and 6 hours after nicotine administration. POPPK analysis was performed using nonlinear mixed effect modelling. Results: One-compartment with 1st order elimination and absorption with 6 transit compartments best described the data. CYP2A6 enzyme activity was a significant covariate on the nicotine clearance. Apparent elimination clearance (CL/F) for a person with 100% CYP2A6 activity was 266.0 L/h. CL/F would be 36.0 L/h in a subject with 0% CYP2A6 activity. However, the impact of non-genetic factors (monthly alcohol consumption, Fagerstrom Test for Nicotine Dependence score and the number of cigarettes per day) on pharmacokinetics of nicotine were not found. Conclusion: This first report on population pharmacokinetics of nicotine gum in Thai smokers provided the pharmacokinetic model and quantified CL/F for smokers with different CYP2A6 genotypes. A markedly lower exposure to nicotine in the Thai population compared to others highlights the need for more studies to ensure the efficacy of nicotine gum in the Thai population. [ABSTRACT FROM AUTHOR]

Background Oral nicotine gum such as LUCY, which comes in colorful packaging, mimicking traditional chewing gum, is becoming popular. Many brands of gum have not been approved by the FDA for smoking cessation. This study examined public discourse about, including sentiment toward, oral nicotine gum on Twitter. Methods We used Twitter's Streaming Application Programming Interface to collect data from January 1, 2021, to December 21, 2021, using "nicotine gum" and/or "#nicotinegum" search terms (N  = 19 171 unique tweets were collected). We used an inductive approach to become familiar with the data, generated a codebook, and conducted a content analysis on (n  = 2152) tweets. Results Cessation (n  = 716, 33.3%), personal experience (n  = 370, 17.2%), and addiction to gum (n  = 135, 6.3%) were the most prevalent themes. Cessation tweets primarily discussed cigarette smoking cessation (n  = 418, 58.4% of cessation tweets) and successful cessation experiences (n  = 155, 21.6%). Other identified themes pertained to using nicotine gum for cognitive enhancement or catching a "buzz" (n  = 102, 4.7%), marketing (n  = 98, 4.6%), using nicotine gum with other substances (n  = 90, 4.2%), and adverse effects (n  = 63, 2.9%). Sentiment analysis results revealed that 675 (44.2%) tweets were categorized as neutral, 605 (39.6%) tweets were classified as positive, and 248 tweets (16.2%) were negative. Conclusions About one-third of tweets in our corpus mentioned nicotine gum in the context of smoking cessation. Most nicotine gum-related posts conveyed positive and neutral sentiments. Future studies should consider adding novel nicotine gum-specific search terms as well as exploring other social media platforms to gain more insights about these products. Implications Our findings suggest that Twitter has the potential to track and facilitate conversations between those seeking cigarette cessation advice and those who have successfully quit tobacco by using nicotine gum. Monitoring of promotional content from nicotine gum companies is needed to ensure these products are not appealing to youth and nonusers of tobacco. [ABSTRACT FROM AUTHOR]

Objective: Despite the popularity of nicotine gum in Thailand, population pharmacokinetics of nicotine gum in the Thai population has not been investigated. This study aimed to develop a population pharmacokinetic (POPPK) model of nicotine and to quantify the effects of genetic and non-genetic factors to nicotine pharmacokinetics. Materials and Methods: Secondary data collected from a previous clinical trial assessing cytochrome P450 2A6 (CYP2A6) genotypes in Thai smokers was investigated. Eighteen participants who had received a single dose of 2 mg nicotine gum were included. Blood samples were collected before, at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4.5 and 6 hours after nicotine administration. POPPK analysis was performed using nonlinear mixed effect modelling. Results: One-compartment with 1st order elimination and absorption with 6-transit compartments best described the data. CYP2A6 enzyme activity was a significant covariate on the nicotine clearance. Apparent elimination clearance (CL/F) for a person with 100% CYP2A6 activity was 266.0 L/h. CL/F would be 36.0 L/h in a subject with 0% CYP2A6 activity. However, the impact of non-genetic factors (monthly alcohol consumption, Fagerstrom Test for Nicotine Dependence score and the number of cigarettes per day) on pharmacokinetics of nicotine were not found. Conclusion: This first report on population pharmacokinetics of nicotine gum in Thai smokers provided the pharmacokinetic model and quantified CL/F for smokers with different CYP2A6 genotypes. A markedly lower exposure to nicotine in the Thai population compared to others highlights the need for more studies to ensure the efficacy of nicotine gum in the Thai population.

Objective: Compare the effectiveness of nicotine gum versus the use of electronic cigarettes and show whether they are more effective in reducing smoking. . Methodology: Articles in Spanish, English and Portuguese, available from SciELO, Google Academic, EBSCO, Cochrane Library and LILACS, were included through equations built with MeSH and DeCS and Boolean operators AND Dec's OR (("Electronic cigarettes" OR "E-Cigs" OR "Electronic Cigars") OR ("Chewing gum" OR "Nicotine chewing gum") AND ("Smoking cessation")). The articles were critically read, and classified by level of evidence and degree of recommendation. Ethical considerations were adopted in accordance with Resolution 8430 of 1993. Results: The initial search yielded 1,468 articles, which were reduced to 28 units that contributed to the stated objective. Five themes were built, which include a comparison of methods, evaluation forms, age ranges, addiction rates, associated pathologies and mortality rate, components and physiological effects of the conventional and electronic cigarette. Conclusions: It is evident that the amounts of nicotine of e-cigarettes produce irreversible adverse health effects and can lead to increased dependency [ABSTRACT FROM AUTHOR]

Electrophysiological studies show that nicotine enhances neural responses to characteristic frequency stimuli. Previous behavioral studies partially corroborate these findings in young adults, showing that nicotine selectively enhances auditory processing in difficult listening conditions. The present work extended previous work to include both young and older adults and assessed the nicotine effect on sound frequency and intensity discrimination. Hypotheses were that nicotine improves auditory performance and that the degree of improvement is inversely proportional to baseline performance. Young (19-23 years old) normal-hearing nonsmokers and elderly (61-80) nonsmokers with normal hearing between 500 and 2000 Hz received nicotine gum (6 mg) or placebo gum in a single-blind, randomized crossover design. Participants performed three experiments (frequency discrimination, frequency modulation identification, and intensity discrimination) before and after treatment. The perceptual differences were analyzed between pre- and post-treatment, as well as between post-treatment nicotine and placebo conditions as a function of pre-treatment baseline performance. Compared to pre-treatment performance, nicotine significantly improved frequency discrimination. Compared to placebo, nicotine significantly improved performance for intensity discrimination, and the improvement was more pronounced in the elderly with lower baseline performance. Nicotine had no effect on frequency modulation identification. Nicotine effects are task-dependent, reflecting possible interplays of subjects, tasks and neural mechanisms.

RATIONALE: Electrophysiological studies show that systemic nicotine narrows frequency receptive fields and increases gain in neural responses to characteristic frequency stimuli. We postulated that nicotine enhances related auditory processing in humans. OBJECTIVES: The main hypothesis was that nicotine improves auditory performance. A secondary hypothesis was that the degree of nicotine-induced improvement depends on the individuals baseline performance. METHODS: Young (18-27 years old), normal-hearing nonsmokers received nicotine (Nicorette gum, 6mg) or placebo gum in a single-blind, randomized, crossover design. Subjects performed four experiments involving tone-in-noise detection, temporal gap detection, spectral ripple discrimination, and selective auditory attention before and after treatment. The perceptual differences between posttreatment nicotine and placebo conditions were measured and analyzed as a function of the pre-treatment baseline performance. RESULTS: Nicotine significantly improved performance in the more difficult tasks of tone-in-noise detection and selective attention (effect size = - 0.3) but had no effect on relatively easier tasks of temporal gap detection and spectral ripple discrimination. The two tasks showing significant nicotine effects further showed no baseline-dependent improvement. CONCLUSIONS: Nicotine improves auditory performance in difficult listening situations. The present results support future investigation of nicotine effects in clinical populations with auditory processing deficits or reduced cholinergic activation.

Purpose: To investigate the immediate impact of nicotine consumption on Retinal Nerve Fiber Layer (RNFL) thickness in healthy young individuals, comparing nicotine gum and electronic cigarette (vaping) as delivery methods., Materials and Methods: Twenty participants underwent RNFL measurements at baseline, 30, and 60 minutes after consuming 4 mg of nicotine, based on product labeling and specifications. Measurements were obtained using optical coherence tomography (OCT) (Topcon 3D OCT-1 Maestro System). Nicotine was delivered through either nicotine gum or vaping., Results: Both nicotine gum and vaping led to a statistically significant increase in RNFL thickness, with no significant difference between the two methods. The analysis revealed that area, time, and visit factors significantly affected RNFL scores. Stratification by smoking type (tobacco, vaping, dual) demonstrated significant effects for area, time, and visit factors, with an interaction effect among these factors., Conclusions: The findings highlight the acute impact of nicotine intake on RNFL thickness in young healthy smokers. Researchers and clinicians should account for recent nicotine exposure when evaluating RNFL thickness, particularly within the first hour post-smoking. The observed significant effects warrant further research, especially in older or health-compromised populations, to improve clinical protocols and diagnostic evaluations across different demographics.

Background and Objective: Heated tobacco products (HTPs) are a class of non-combustible, inhaled tobacco products with the potential to reduce the harm associated with cigarette smoking due to reduced cigarette smoke toxicant exposure. Subjective and nicotine pharmacokinetics measures taken over the course of product use provide a framework for abuse liability (AL) assessment of tobacco and nicotine products as well as information on adoption potential for a new tobacco product, which are important aspects for premarket tobacco product authorization by the US Food and Drug Administration. This study aimed to assess the AL of glo HTPs, operated in either Standard or Boost Modes, compared with high- and low-AL comparators (subjects' usual brand cigarettes and nicotine gum, respectively)., Methods: Nicotine uptake and pharmacodynamics measures (including subjective and physiological measures) were assessed in a clinical study of 75 healthy adult non-menthol or menthol smokers using an open-label, randomized crossover study design. Comparisons were made between glo HTPs (Standard or Boost Modes) and each of usual brand (UB) cigarettes and nicotine gum to evaluate nicotine exposure and subjective effects measures., Results: Nicotine uptake, as reflected in the area under the curve (AUC) at 15 and 240 min after product use (AUC 0-15 and AUC 0-240 , respectively) and maximum nicotine concentration (C max ) were significantly lower for all glo HTPs compared to UB cigarettes, regardless of the glo device mode. AUC 0-15 values for glo HTPs ranged from 41.26 to 75.71 ng × min/mL, versus 158.04 to 165.53 ng × min/mL for UB cigarettes. Similarly, AUC 0-240 values for glo HTPs ranged from 379 to 596 ng × min/mL, compared to 1123.73 and 1283.37 ng × min/mL for UB cigarettes. The C max for glo HTPs ranged from 5.46 to 9.00 ng/mL, whereas UB cigarettes had C max values of 16.29 to 16.76 ng/mL. The time to reach maximum nicotine concentration (T max ) was significantly shorter for glo HTPs (4-5 min) compared to UB cigarettes (6-7 min), except for one variant of glo HTP in Standard Mode. Nicotine gum exhibited a slower nicotine absorption profile, with a T max of 45 min and C max of 4.60 ng/mL. AUC 0-15 and AUC 0-240 values for nicotine gum were 6.18 and 5.22 ng × min/mL, and 647.80 and 687.68 ng × min/mL for non-menthol and menthol groups, respectively. Subjective measures indicated that glo HTPs were rated significantly lower than UB cigarettes in terms of product liking, smoking urge reduction, product effects, and intent to use again, but were comparable to nicotine gum., Conclusion: glo HTPs demonstrated lower AL than combustible cigarettes while delivering sufficient nicotine to support product adoption among current smokers. This positions glo HTPs as a potential tool in tobacco harm reduction, offering a less harmful alternative to traditional cigarettes., Trial Registry: Clinical trial ID NCT05114863., (© 2024. The Author(s).)

Objective: to synthesize evidence about the efficacy of electronic cigarettes versus Nicotine Replacement Therapy and placebo to quit smoking. Data sources: We searched for clinical trials with no publication date restriction until December 2019. The search included CENTRAL, MEDLINE, PsycINFO, Science Direct, Center for reviews and dissemination and HTA database and Trip database, clinical trials registries, gray literature and examined the references of relevant articles. Inclusion and exclusion criteria: Two review authors independently checked the titles and abstracts then the full text of initial hits. Main outcomes were sustained continuous abstinence rate, 7-day point prevalence abstinence rate, sustained reduction of 50% or greater in baseline cigarette consumption and adverse effects. Data extraction and synthesis: Two review authors independently extracted data and assessed risk of bias using the Cochrane RoB 2 tool. We conducted a random-effects model through the Mantel-Haenszel method. Results: We retrieved 12 trials involving 9863 participants. CO- validated 1-month continuous abstinence rate improved by 33% in the e-cigarettes group (range 6-66%, moderate evidence). We are uncertain if e-cigarettess influence continuous abstinence rate at 3-, 6- and 12 months as well as sustained reduction of 50% or greater in baseline cigarette consumption at different follow-up periods. One study of 884 participants displayed improved 12-month 7-day point abstinence by 46% (range 17%-82%). E-cigarettes may increase or do not affect the proportion of serious adverse effect at 6 and 12 months follow up. Conclusion: Very low certainty evidence supported e-cigarettess to help quit smoking in the short term. There is not enough evidence to determine if e-cigarettess are a safe and efficacious means of smoking cessation in the long term (12+ months). [ABSTRACT FROM AUTHOR]

Purpose: To explore whether differences in choroidal thickness arise from nicotine consumption in healthy young individuals, specifically comparing the effects of nicotine gum to electronic cigarette (vaping), while maintaining a consistent 4 mg nicotine dosage., Methods: In a randomized double-blinded prospective cross-sectional study, 20 healthy participants (mean age ± standard deviation: 23 ± 2.36 years) were randomly assigned to either the nicotine gum or vaping group. Choroidal thickness (ChT) measurements were conducted using optical coherence tomography (OCT) (Topcon 3D OCT-1 Maestro System) at baseline, 30, and 60 min after ingesting 4 mg of nicotine, with ChT measurements taken from five different horizontal areas., Results: Neither the nicotine delivery method (gum or vaping) demonstrated a statistically significant impact on ChT mean scores among subjects in the five measured areas at baseline, 30, and 60 min (p > 0.05). However, significant differences were observed in ChT mean scores within subjects across the five areas (F (1.83, 72) = 36.43, p < 0.001), regardless of other study factors such as group, time, and visit (p > 0.05). A statistically significant interaction was identified between the factors of area and time concerning participants' ChT mean scores when stratified by the type of smoking (tobacco, vaping, and dual) (p = 0.003)., Conclusion: The results of this study revealed that nicotine, up to particular concentration of 4 mg, does not have a statistically significant vasoconstrictive effect on choroidal thickness, regardless of the delivery method, within the examined group. These findings offer valuable insights into the relationship between nicotine intake and choroidal dynamics in young adults., (© 2024. The Author(s), under exclusive licence to Springer Nature B.V.)

Background: There are a limited number of studies that have examined the real-world effectiveness of smoking cessation aids and relapse longitudinally in population-representative samples. This study examines the association between use of nicotine gum, patch, bupropion, and varenicline and time to relapse as well as any changes in the association with increased length of abstinence.Methods: Data of 1821 current adult smokers (18+) making their first serious quit attempt were compiled from 4504 individuals enrolled in the Ontario Tobacco Survey, a representative telephone survey of Ontario adults, which followed smokers every 6 months for up to 3 years. Use of cessation aids at the time of initial report of a quit attempt was analyzed. A flexible parametric survival model was developed to model length of abstinence, controlling for potential confounders.Results: The best fit model found knots at 3, 13, 43, and 212 days abstinent, suggesting different rates of relapse in the periods marked by those days. Use of the patch and varenicline was associated with lower rates of relapse, but no positive effect was found for bupropion or nicotine gum. The effectiveness of the patch reversed in effect after the first month of abstinence.Conclusions: This study is one of few reports of long-term quitting in a population-representative sample and demonstrates that the effectiveness of some pharmacological cessation aids (the patch and varenicline can be seen in a population sample). Previous failures in real-world studies of the effectiveness of smoking cessation aids may reflect differences in the products individuals use and differences in the timing of self-reported cessation.Implications: While a large number of randomized controlled trials have shown the efficacy of many pharmaceutical smoking cessation aids, evidence of their effectiveness in observational studies in the real world is ambiguous. This study uses a longitudinal cohort of a representative sample of smokers to show that the effectiveness of pharmaceutical cessation aids can be demonstrated in real-world use situations, but effectiveness varies by product type and has time-varying effects. [ABSTRACT FROM AUTHOR]

Introduction: Non-daily intermittent smokers (ITS) comprise 30% of US adult smokers. ITS smoke for nicotine and have trouble quitting, but tend to smoke in particular situations. This study tested the effect of nicotine gum, used to prevent or react to situational temptations, for helping ITS quit.Methods: ITS (smoking 4-27 days/month) seeking help quitting were randomized to 2 mg nicotine gum (n = 181) or placebo (n = 188), to be used to anticipate or react to temptations to smoke, for 8 weeks. Participants received up to six sessions of behavioral counseling. The primary outcome was 6-month biochemically verified continuous abstinence; analyses also examined 14-day point-prevalence abstinence at multiple time points, and used event-history analyses to assess progression to abstinence, lapsing, and relapsing. Analyses adjusted for group differences in age and baseline smoking, and considered several potential moderators of treatment effects.Results: Nicotine gum did not significantly improve outcomes on any measure. Biochemically verified 6-month continuous abstinence rates were 7.2% for active gum and 5.3% for placebo (AOR = 1.39, 0.58-3.29, p > .25). ITS with any degree of dependence (Fagerstrom Test of Nicotine Dependence scores >0) showed poorer outcomes on multiple endpoints, and did more poorly on active gum on some outcomes. Gum use was low, starting at 1 gum per day on average and declining over time.Conclusions: Nicotine gum (2 mg), used intermittently, did not improve cessation rates among ITS, including those demonstrating some degree of dependence.Implications: Nicotine replacement has been extensively tested with daily smokers, especially those who smoke relatively heavily. Nondaily smoking is now common, creating a need for treatment for ITS. Despite evidence that ITS' smoking is motivated by nicotine-seeking, a theoretically and empirically derived situational approach to using acute nicotine replacement was not successful at helping ITS quit. Gum use was low; whether higher or more frequent dosing is needed, or whether an entirely different approach is needed, is not clear. Effective treatment options are needed for ITS, especially those with some degree of dependence. [ABSTRACT FROM AUTHOR]

Background: Understanding study characteristics' influence on treatment efficacy could improve interpretation of trials' outcomes. We examined study characteristics as predictors of outcomes in clinical trials of medications for tobacco use.Methods: We obtained and analyzed data on 44 trials of nicotine gum, 37 trials of nicotine patch, 27 trials of varenicline, and 43 trials of bupropion from Cochrane reviews. We extracted and analyzed data for 15 study characteristics, odds ratios (ORs), and percent abstinent in control and medication conditions. We used general linear models to determine which study characteristics explained the variability among outcomes after controlling for medication characteristics.Results: Study characteristics accounted for 12% of the variance in odds ratios among patch trials, 16% among gum trials, 16% among varenicline trials, and 34% among bupropion trials above and beyond medication characteristics. Patch and gum trials with industry funding had larger odds ratios than those without. Among patch trials, this appeared to be due to less abstinence in industry-funded trials' control conditions. Bupropion trials published earlier had larger odds ratios, which appeared to be due to less abstinence in control conditions. The reason for study characteristics' influence on varenicline trials was unclear.Discussion: Study characteristics influenced the assessment of treatment efficacy above and beyond medication characteristics in smoking cessation trials. Our findings that study characteristics are associated with higher or lower efficacy does not suggest that the effect size under one versus another condition is the more valid outcome. Future studies are needed to determine which study characteristics reliably influence efficacy because this would help investigators and clinicians interpret trials.Implications: Study characteristics influenced the estimates of treatment efficacy but individual characteristics' influence on efficacy appeared to differ among different medications for smoking cessation. We encourage researchers to report study characteristics to improve interpretation of findings and systematic reviews, and to account for nontreatment-related variables to better estimate the efficacy of treatments. [ABSTRACT FROM AUTHOR]

Importance: Electronic cigarettes (ECs) are often used by smokers as an aid to stopping smoking, but evidence is limited regarding their efficacy compared with nicotine replacement therapy (NRT), and no evidence is available on how their efficacy compares with that of varenicline., Objective: To evaluate whether ECs are superior to NRT and noninferior to varenicline in helping smokers quit., Design, Setting, and Participants: This was a randomized clinical trial conducted at 7 sites in China and including participants who were smoking at least 10 cigarettes per day and motivated to quit, not using stop-smoking medications or EC, and willing to use any of the study products. Participants were first recruited in May 2021, and data analysis was conducted in December 2022., Interventions: A cartridge-based EC (30 mg/mL nicotine salt for 2 weeks and 50 mg/mL after that), varenicline (0.5 mg, once a day for 3 days; 0.5 mg, twice a day for 4 days; and 1 mg, twice a day, after that), and 2 mg (for smokers of ≤20 cigarettes per day) or 4 mg (>20 cigarettes per day) nicotine chewing gum, all provided for 12 weeks and accompanied by minimal behavioral support (an invitation to join a self-help internet forum)., Main Outcomes and Measures: The primary outcome was sustained abstinence from smoking at 6 months as validated by an expired-air carbon monoxide reading (<8 parts per million). Participants lost to follow-up were included as nonabstainers., Results: Of 1068 participants, 357 (33.5%) were female, and the mean (SD) age was 33.9 (3.1) years. A total of 409 (38.3%), 409 (38.3%), and 250 (23.4%) participants were randomized to the EC, varenicline, and NRT arms, respectively. The 6-month biochemically validated abstinence rates were 15.7% (n = 64), 14.2% (n = 58), and 8.8% (n = 22) in the EC, varenicline, and NRT study arms, respectively. The quit rate in the EC arm was noninferior to the varenicline arm (absolute risk reduction, 1.47%; 95% CI, -1.41% to 4.34%) and higher than in the NRT arm (odds ratio, 1.92; 95% CI, 1.15-3.21). Treatment adherence was similar in all study arms during the initial 3 months, but 257 participants (62.8%) in the EC arm were still using ECs at 6 months, with no further use in the 2 other study arms. The most common adverse reactions were throat irritation (32 [7.8%]) and mouth irritation (28 [6.9%]) in the EC arm, nausea (36 [8.8%]) in the varenicline arm, and throat irritation (20 [8.0%]) and mouth irritation (22 [8.8%]) in the NRT arm. No serious adverse events were recorded., Conclusions and Relevance: The results of this randomized clinical trial found that when all treatments were provided with minimal behavior support, the efficacy of EC was noninferior to varenicline and superior to nicotine chewing gum., Trial Registration: Chinese Clinical Trial Registry: ChiCTR2100048156.

Introduction: The aerosol composition of electronic cigarettes (ECs) suggests that exposure to toxicants during use is greatly reduced compared to exposure from combustible cigarettes (CCs).Methods: This randomized, parallel-group, clinical study enrolled smokers to switch to Vuse Solo (VS) Digital Vapor Cigarettes (Original or Menthol) or Nicorette 4 mg nicotine gum (NG) in a controlled setting. Subjects who smoked CCs ad libitum for 2 days during a baseline period were then randomized to ad libitum use of either VS or NG for 5 days. Biomarkers of 23 toxicants were measured in 24-hour urine samples and blood collected at baseline and following product switch.Results: A total of 153 subjects completed the study. Total nicotine equivalents decreased in all groups, but higher levels were observed in the VS groups compared to the NG groups, with decreases of 38% and 60%-67%, respectively. All other biomarkers were significantly decreased in subjects switched to VS, and the magnitude of biomarker decreases was similar to subjects switched to NG. Decreases ranged from 30% to greater than 85% for constituents such as benzene and acrylonitrile.Conclusions: These results indicate that exposure to toxicants when using VS is significantly reduced compared to CC smoking, and these reductions are similar to those observed with use of NG. Although statistically significantly decreased, nicotine exposure is maintained closer to CC smoking with VS use compared to NG use. This research suggests that use of VS exposes consumers to fewer and lower levels of smoke toxicants than CCs while still providing nicotine to the consumer.Implications: This is the first study to report changes in nicotine delivery and biomarkers of tobacco exposure following a short-term product switch from CCs to either an EC or NG in a controlled environment. The study shows that nicotine exposure decreased in both groups but was maintained closer to CC smoking with the EC groups. Biomarkers of tobacco combustion decreased to similar levels in both EC and gum groups. [ABSTRACT FROM AUTHOR]

Introduction One cause for low blood pressure (BP) in Parkinson's disease (PD) is denervation of the sympathetic nervous system and reduced levels of norepinephrine. Nicotine increases heart rate and BP acutely by causing sympathetic stimulation. The absorption rate of nicotine gum is relatively quick and absorbed at a constant rate. Our objective was to evaluate how nicotine gum affects acute low BP in PD. Methods Ten subjects (age 69.3 ± 8.8) completed this double blind, placebo controlled, cross-over design trial using nicotine gum (4 mg) and placebo gum on two separate days. The gum was administered for 30 min. BP was recorded every 10 min for 90 min. Results On the nicotine gum treatment day, the baseline systolic BP was 94.8 (standard deviation [SD] = 4.4), and it increased in a parabolic pattern to be 115.8 (SD = 11.2) in 20 min, 124.2 (SD = 9.3) in 40 min, and 133.2 (SD = 13.1) in 60 min reaching the highest value, and then decreased to be 121.6 (SD = 10.4) in 90 min. On the placebo day, the baseline systolic BP 95.2 (SD = 3.0) didn't show an outstanding change with the mean systolic BP values from 93.0 to 95.7 (SD from 2.1 to 3.7) at all time points. Conclusions Our data suggests that 4 mg of nicotine gum can increase systolic BP within 10 min of administration. It is strongly warranted that further research should pursue the use of nicotine gum as an intervention to treat acute episodes of low BP in individuals with PD. Implications More than 50% of Parkinson's disease (PD) patients have low blood pressure (BP) that fluctuates throughout the day and decreases quality of life. This study found an increase in systolic blood pressure within 10 min of administering nicotine gum to Parkinson's subjects with low BP. Their BP remained elevated for 90 min. Nicotine gum gets absorbed rapidly and may act as a therapeutic novel approach to individuals whose daily lives are interrupted with low BP. [ABSTRACT FROM AUTHOR]

An assessment of the likelihood of use and abuse potential for new tobacco products is an important part of tobacco product regulation in the United States and abroad. This paper reports the results of a randomized, open-label, crossover clinical study that assessed factors related to product adoption and abuse liability (AL), comparing two closed electronic nicotine delivery system (ENDS) products to combustible cigarettes and nicotine gum, high- and low-AL comparator products, respectively. During an 11-day confinement period that included multiple product familiarization sessions, healthy adult smokers participated in AL test sessions to evaluate the abuse liability of each product. During these test sessions, changes in subjective measures; speed and amount of nicotine uptake; and maximum changes in physiological effects before, during, and after use of each assigned product were assessed over 4 h. Positive subjective effects measures scores such as product-liking and overall intent to use again were highest for cigarettes, followed by the Vuse ENDS, with nicotine gum consistently having the lowest scores. The PK results (C max and T max ) of the Vuse ENDS products are between UB cigarettes and nicotine gum, which correlates with the subjective effects. All nicotine uptake measures for the Vuse ENDS products were lower than that of usual brand (UB) cigarettes, including peak nicotine uptake and overall nicotine uptake, and were either similar to or lower than nicotine gum. The time course of nicotine uptake after use of the ENDS was more similar to that of combustible cigarettes than nicotine gum. The results indicate that the AL of each ENDS product is lower than that of UB cigarettes and similar to that of nicotine gum., (© 2023. The Author(s).)

Introduction: The US Food and Drug Administration (FDA) has purview over tobacco products. To set policy, the FDA must rely on sound science, yet most existing tobacco research methods have not been designed to specifically inform regulation. The NCI and FDA-funded Consortium on Methods Evaluating Tobacco (COMET) was established to develop and assess valid and reliable methods for tobacco product evaluation. The goal of this article is to describe these assessment methods using a US manufactured "snus" as the test product.Methods: In designing studies that could inform FDA regulation, COMET has taken a multidisciplinary approach that includes experimental animal models and a range of human studies that examine tobacco product appeal, addictiveness, and toxicity. This article integrates COMET's findings over the last 4 years.Results: Consistency in results was observed across the various studies, lending validity to our methods. Studies showed low abuse liability for snus and low levels of consumer demand. Toxicity was less than cigarettes on some biomarkers but higher than medicinal nicotine.Conclusions: Using our study methods and the convergence of results, the snus that we tested as a potential modified risk tobacco product is likely to neither result in substantial public health harm nor benefit.Implications: This review describes methods that were used to assess the appeal, abuse liability, and toxicity of snus. These methods included animal, behavioral economics, consumer perception studies, and clinical trials. Across these varied methods, study results showed low abuse-liability and appeal of the snus product we tested. In several studies, demand for snus was lower than for less toxic nicotine gum. The consistency and convergence of results across a range of multi-disciplinary studies lends validity to our methods and suggests that promotion of snus as a modified risk tobacco products is unlikely to produce substantial public health benefit or harm. [ABSTRACT FROM AUTHOR]

Purpose: When postoperative ileus is not resolved after 5 days or recurs after resolution, prolonged POI (PPOI) is diagnosed. PPOI increases discomfort, morbidity and hospitalisation length, and is mainly caused by an inflammatory response following intestinal manipulation. This response can be weakened by targeting the cholinergic anti-inflammatory pathway, with nicotine as essential regulator. Chewing gum, already known to stimulate gastrointestinal motility itself, combined with nicotine is hypothesised to improve gastrointestinal recovery and prevent PPOI. This pilot study is the first to assess efficacy and safety of nicotine gum in colorectal surgery. Methods: Patients undergoing elective oncological colorectal surgery were enrolled in this double-blind, parallel-group, controlled trial and randomly assigned to a treatment protocol with normal or nicotine gum (2 mg). Patient reported outcomes (PROMS), clinical characteristics and blood samples were collected. Primary endpoint was defined as time to first passage of faeces and toleration of solid food for at least 24 h. Results: In total, 40 patients were enrolled (20 vs. 20). In both groups, six patients developed PPOI. Time to primary endpoint (4.50 [3.00-7.25] vs. 3.50 days [3.00-4.25], p = 0.398) and length of stay (5.50 [4.00-8.50] vs. 4.50 days [4.00-6.00], p = 0.738) did not differ significantly between normal and nicotine gum. There were no differences in PROMS, inflammatory parameters and postoperative complications. Conclusions: We proved nicotine gum to be safe but ineffective in improving gastrointestinal recovery and prevention of PPOI after colorectal surgery. Other dosages and administration routes of nicotine should be tested in future research. [ABSTRACT FROM AUTHOR]

Abuse liability (AL) of electronic nicotine delivery systems (ENDS) is relevant as the category increases in popularity as a potentially less-harmful alternative to cigarette smoking. AL assessments are important to the FDA in determining if a new product is appropriate for the protection of public health. This paper reports the results for Vuse Solo (G2 cartridge design) compared to high and low AL-comparators evaluated in an open-label, randomized crossover confinement AL study. The confinement design was adapted from previous ambulatory studies of Vuse Solo (G1 cartridge design) and included product familiarization sessions before each four-hour test session in which subjective measures, nicotine pharmacokinetics (PK), and physiological endpoints were assessed following a single 10-min ad libitum product use session. Product liking, intent to use again, suppression of urge to smoke, and nicotine PK were lower after use of Vuse Solo compared to cigarettes and higher after use of Vuse Solo compared to nicotine gum. No significant differences in blood pressure or heart rate were observed between the products pre- to post-product use. These data reinforce previous research and provide the scientific evidence to support regulatory decisions demonstrating that Vuse Solo has an AL profile lower than that of combustible cigarettes but higher than that of nicotine gum and, therefore, may be a suitable replacement for cigarette smoking for some adult smokers., (© 2022. The Author(s).)

Rationale: Since tobacco contains numerous harmful substances, besides nicotine, which is addictive, smoking cessation products and tobacco alternatives, such as electronic (e-) cigarettes, nicotine chewing gums, and patches, are being widely used. Nicotine gums are consumed orally. The nicotine from the gum is absorbed at a slower rate than that from e-cigarettes, and the former remains in the bloodstream for a longer period. In addition, the maximum number of daily doses is high, and it can be purchased without a doctor's prescription in many countries., Patient Concerns: A 29-year-old male patient consumed 5 2-mg nicotine gums at a time, twice a day, for 4 days (total amount: 70 mg). However, he visited the emergency unit with the chief complaint of involuntary limb movements after consuming an additional 15 gums 3 hour before the visit. At admission, his consciousness was clear, although 2 hour later, he experienced sudden loss of consciousness with worsening hypoxia and respiratory acidosis., Diagnosis: The patient's vital signs were stable at the time of admission, and blood test results showed no specific findings other than a white blood cell count of 14,800/µL, lactate level of 6.4 mmol/L, and prolactin level of 119.02 ng/mL. In addition, chest radiography and head computed tomography scans showed no acute phase abnormalities. Two hours later, he experienced loss of consciousness and respiratory failure, and the results of blood tests performed at this time showed that his blood cotinine level was 3491 ng/mL., Interventions: Supportive treatment, including endotracheal intubation followed by mechanical ventilation, was provided., Outcome: The patient's vital signs stabilized 3 days after treatment, and his consciousness and respiratory status had improved; therefore, mechanical ventilation was stopped. His condition was stable for the next 2 days, and he was discharged on the fifth day., Lessons: Acute respiratory exacerbation due to nicotine poisoning (from levels exceeding the lethal dose of 30-60 mg) was observed, although the gums were consumed over several days. Patients with nicotine poisoning may show acute respiratory failure and should be monitored carefully. Further studies are required to determine the toxic effects of nicotine replacement therapies., Competing Interests: The authors have no funding and conflicts of interest to disclose., (Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.)