Smoking reduction using electronic nicotine delivery systems in combination with nicotine skin patches.

RATIONALE: Electronic nicotine delivery systems (ENDS) are used by smokers seeking to reduce combustible cigarette (CC) use, but the role of nicotine replacement vs. behavioral and sensory factors is still poorly understood. We hypothesized that providing nicotine from ENDS in addition to nicotine skin patches would promote smoking reduction relative to non-nicotine control ENDS. OBJECTIVES: To assess the effects on smoking behavior of using nicotine vs. placebo ENDS in smokers using nicotine vs. placebo patches. METHODS: Ninety-four daily smokers were enrolled in a study that randomly assigned them to receive ENDS with nicotine vs. without nicotine and skin patches with vs. without nicotine. Smoking reduction and cessation were assessed over an 8-week period by self-report and by expired air carbon monoxide (CO) measurements. The primary outcome was defined as reduction in expired air CO. RESULTS: The use of nicotine in ENDS led to significant reductions in smoking (ENDS nicotine vs. placebo difference in CO change = -9.2 ppm; 90% CI (-1.5 ppm, -16.9 ppm)) and was highly correlated with reductions in self-reported cigarettes per day (r=0.6). The effect of nicotine in nicotine patches was not statistically significant (patch nicotine vs. placebo difference in CO change = -0.1 ppm; 90% CI (-7.8 ppm, 7.6 ppm)). CONCLUSIONS: The presence of nicotine in ENDS was associated with a large reduction in smoking. Additional studies will be needed to determine whether there may be additive effects of nicotine ENDS and nicotine patches on smoking abstinence.

Analgesic potential of transdermal nicotine patch in surgery: a systematic review and meta-analysis of randomised placebo-controlled trials.

OBJECTIVES: We aimed (1) to systematically review the efficacy of transdermal nicotine patches (NP) for postoperative analgesia, (2) to establish the current quality of evidence and assist clinical decision-making on the subject, and (3) to identify methodological limitations and the need for more well-designed studies. MATERIALS AND METHODS: We searched six electronic databases, protocol records, and other sources without date or language restriction until March 2022. To develop the search strategy, we formulated a clinical question by using the PICOD method. Eligibility criteria included randomised placebo-controlled trials on the analgesic potential of NP for surgical procedures. This systematic review followed the PRISMA 2020 statement, and we registered the protocol in PROSPERO (#CRD42020205956). RESULTS: We included 10 randomised placebo-controlled trials (535 patients). The NP administered before induction of anaesthesia and at beginning of surgery reduced the pain immediately after surgery (-0.38; 95% confidence interval [CI]: -0.73 to -0.02), and 6 h (-0.34; 95% CI: -0.68 to -0.01), 12 h (-0.43; 95% CI: -0.71 to -0.15) and 24 h (-0.35; 95%CI: -0.59 to -0.10) after surgery, compared with the placebo patch (PP) group. Sensitivity testing suggests that opioid use could underestimate NP analgesia. Late demand for the first analgesic and consumption of rescue analgesics tended to be lower in the NP group. CONCLUSIONS: The current findings suggest, with low certainty of evidence, the analgesic potential of NP for surgical procedures. CLINICAL RELEVANCE: Perioperative use of NP significantly improved postoperative pain, even when opioids were administered or prescribed. Nevertheless, the clinical relevance should be interpreted with caution, owing to the effect sizes of the summary measures and methodological issues. The analgesic potential of NP as an adjuvant therapy to regulate pain and acute inflammation may offer certain clinical advantages, thus warranting further investigation.

[Auricular point sticking combined with transcutaneous electrical acupoint stimulation for smoking cessation：a randomized controlled trial].

OBJECTIVE: To compare the clinical efficacy between auricular point sticking combined with transcutaneous electrical acupoint stimulation (TEAS) and nicotine patch for smoking cessation. METHODS: Two hundred patients who voluntarily quit smoking were randomly divided into a combination group and a nicotine patch group, 100 cases in each group. In the combination group, auricular point sticking (Shenmen [TF4], Neifenmi [CO18], Pizhixia [AT4], Jiaogan [AH6a], etc., once every other day) combined with TEAS（Lieque [LU 7] and Zusanli [ST 36], with continuous wave, 20 Hz in frequency, 1 mA in current intensity, 30 min each time, once a day) were applied. In the nicotine patch group, nicotine patch was applied. Both groups were treated for 8 weeks. The immediate withdrawal rate and persistent withdrawal rate 8 weeks into treatment and in follow-up of 16 weeks after treatment in the two groups were compared; before treatment, 8 weeks into treatment and in follow-up of 16 weeks after treatment, the degree of nicotine dependence was evaluated by using Fagerström test for nicotine dependence (FTND); 1 week into treatment, 8 weeks into treatment and in follow-up of 16 weeks after treatment, the withdrawal symptoms and smoking craving were evaluated by using Minnesota nicotine withdrawal scale (MNWS); the safety and compliance (dropped off rate and treatment completeness) were evaluated in the two groups. RESULTS: There was no statistical significance of the differences in the immediate withdrawal rate and persistent withdrawal rate 8 weeks into treatment and during follow-up between the two groups (P>0.05). The FTND scores were decreased 8 weeks into treatment and during follow-up in the two groups compared with those before treatment (P<0.01); the FTND score during follow-up in the combination group was lower than the nicotine patch group (P<0.05). The MNWS scores were decreased 8 weeks into treatment and during follow-up in the two groups compared with those 1 week into treatment (P<0.05); the changes of MNWS scores 8 weeks into treatment and during follow-up in the combination group were greater than the nicotine patch group (P<0.05, P<0.01). There were no serious adverse reactions in either group. Eight weeks into treatment and during follow-up, the dropped off rates were all 16.0% (16/100) in the combination group, which were 20.0% (20/100) and 23.0% (23/100) in the nicotine patch group, there was no statistical significance of the differences in the two groups (P>0.05). There was no significant difference in treatment completeness between the two groups (P>0.05). CONCLUSION: Auricular point sticking combined with TEAS could effective decrease the degree of nicotine dependence, improve withdrawal symptoms in smokers, its effect is superior to nicotine patch.

Pharmaceutical interventions: A solution to stop smoking.

Background: Smoking has become a worldwide problem and the more problematic is when the youth of any country is highly involved in consuming tobacco that is dangerous for the human being. The Indian youth is involved in smoking-like activities that are dangerous for them. Objectives: To analyze the role of new treatment ways including nicotine gum, nicotine patch, and nicotine replacement therapy backed by pharmaceutical interventions to eliminate smoking from Indian society. Method: The hypotheses of this study are formed on the basis of previous studies and the identification of gap in practices. This study is based on the cross-sectional data that was collected with the help of a questionnaire based on a five-point Likert scale from the Indian pharma industry people. The sample size for this study was 340 with a response rate of 50%. Results: In this study, 179 valid questionnaires were collected back from the respondents, and according to the results, nicotine gum, nicotine patch, and nicotine replacement therapies have a significant (p<0.05) effect on smoker attitudes. Conclusion: This study concludes that pharmaceutical interventions are critical to stopping the smoking habit in Indian society, and this contribution is providing a solution to stop smoking by affecting the smoker's attitude and smoking behavior.

Estimation of risk of neuropsychiatric adverse events from varenicline, bupropion and nicotine patch versus placebo: secondary analysis of results from the EAGLES trial using Bayes factors.

BACKGROUND AND AIMS: Analysed using classical frequentist hypothesis testing with alpha set to 0.05, the Evaluating Adverse Events in a Global Smoking Cessation Study (EAGLES) did not find enough evidence to reject the hypothesis of no difference in neuropsychiatric adverse events (NPSAEs) attributable to varenicline, bupropion, or nicotine patch compared with placebo. This might be because the null hypothesis was true or because the data were insensitive. The present study aimed to test the hypothesis more directly using Bayes factors. DESIGN: EAGLES was a randomised, double-blind, triple-dummy, controlled trial. SETTING: Global (16 countries across five continents), between November 2011 and January 2015. PARTICIPANTS: Participants were smokers with (n = 4116) and without (n = 4028) psychiatric disorders. INTERVENTIONS: Varenicline (1 mg twice daily), bupropion (150 mg twice daily), nicotine patch (21 mg once daily with taper) and matched placebos. MEASUREMENTS: The outcomes included: (i) a composite measure of moderate/severe NPSAEs; and (ii) a composite measure of severe NPSAEs. The relative evidence for there being no difference in NPSAEs versus data insensitivity for the medications was calculated in the full and sub-samples using Bayes factors and corresponding robustness regions. FINDINGS: For all but two comparisons, Bayes factors were <1/3, indicating moderate to strong evidence for no difference in risk of NPSAEs between active medications and placebo (Bayes factor = 0.02-0.23). In the psychiatric cohort versus placebo, the data were suggestive, but not conclusive of no increase in NPSAEs with varenicline (Bayes factor = 0.52) and bupropion (Bayes factor = 0.71). Here, the robustness regions ruled out a ≥7% and ≥8% risk increase with varenicline and bupropion, respectively. CONCLUSIONS: Secondary analysis of the Evaluating Adverse Events in a Global Smoking Cessation Study trial using Bayes factors provides moderate to strong evidence that use of varenicline, bupropion or nicotine patches for smoking cessation does not increase the risk of neuropsychiatric adverse events relative to use of placebo in smokers without a history of psychiatric disorder. For smokers with a history of psychiatric disorder the evidence also points to no increased risk but with less confidence.

Effects of transdermal nicotine delivery on cognitive outcomes: A meta-analysis.

OBJECTIVE: By the association of nicotinic acetylcholine receptors in the brain, nicotine in the therapeutic window lowers neuronal damage and raises protective factors. These data, however, are contradicted by other findings. Here, we assessed the effects of transdermal nicotine administration on cognitive functions in healthy non-smoker adults by systematic review and meta-analysis of clinical trials. METHODS: We included reports of clinical trials comparing the effects of nicotine patches with placebo in healthy non-smoking adults. The main outcome was the impact of nicotine patches on overall cognitive function with a focus on attention and memory. Standard meta-analytic and statistical methods measured the effect of transdermal nicotine compared with placebo patches. RESULTS: We included 31 publications involving 978 subjects. Nicotine patches boosted cognitive function in healthy adults (0.233 SMD, 95%CI, 0.111-0.355, p < .001). Overall heterogeneity of the studies was found to be modest (Ï°2  = 68.24, T2  = 0.07, I2  = 50.17%, p < .001). Also, nicotine patches improved attention (0.231 SMD, 95%CI, 0.106-0.356, p < .001). We found the inter-study heterogeneity to be low (Ï°2  = 40.95, T2  = 0.03, I2  = 34.07%, p = .042). Further, the enhancement of memory by transdermal nicotine did not reach statistical significance in normal subjects (0.270 SMD, 95% CI, -0.293-0.833, p = .347). Also, high inter-study heterogeneity was found among studies (Ï°2  = 27.25, T2  = 0.43, I2  = 77.98%, p < .001). CONCLUSION: The meta-analysis showed that transdermal nicotine had statistically significant positive effects on attention, and non-significant effects on memory, in healthy non-smoking adults. The results encourage further studies of the therapeutic potential of nicotine patches in disorders of cognition.

Comparative effects of varenicline or combination nicotine replacement therapy versus patch monotherapy on candidate mediators of early abstinence in a smoking cessation attempt.

BACKGROUND AND AIMS: The phase-based model of smoking cessation treatment suggests that treatment needs may vary across phases (e.g. pre-cessation, cessation). This study tested the comparative effects of varenicline and combination nicotine replacement therapy (C-NRT) relative to nicotine patch monotherapy on pre-cessation and cessation phase candidate withdrawal, expectancy and motivation mediators; relations between mediators and abstinence; and indirect effects of enhanced treatments on abstinence via candidate mediators. DESIGN: Secondary mediation analysis of data from the open-label, randomized Wisconsin Smokers' Health Study 2, a comparative effectiveness trial of varenicline or C-NRT, versus patch monotherapy, in adults who smoked, recruited via media and community outreach. SETTING: Research clinics in Madison and Milwaukee, Wisconsin, USA. PARTICIPANTS: A total of 1051 daily smokers motivated to quit smoking (52.5% female; mean age = 48.1, standard deviation = 11.6). INTERVENTIONS: Twelve weeks of varenicline (n = 407) or 12 weeks of combination nicotine patch and nicotine lozenge therapy (n = 421), both compared with 12 weeks of patch control condition (n = 230), with individual smoking cessation counseling. MEASUREMENTS: The primary abstinence outcome was biochemically verified 7-day point-prevalence abstinence 4 weeks post-target quit day (TQD). Candidate mediators (craving, positive smoking expectancies, withdrawal symptoms, and quitting motivation) were assessed via ecological momentary assessment from 1 week prior (pre-cessation phase) to 4 weeks after (cessation phase) the TQD. FINDINGS: Pre-cessation and cessation mean levels and slopes of craving [adjusted odds ratio (aOR) = 0.34-0.79], smoking expectancies (aOR = 0.46-0.79) and quitting motivation (aOR = 1.35-7.21) significantly predicted 4-week post-TQD abstinence (P < 0.05). Significant varenicline mediation occurred via greater suppression in pre-cessation craving [mediated effect (ab) = 0.09, standard error (SE) = 0.03, 95% confidence interval (CI) = 0.04-0.14] and smoking expectancies (ab = 0.06, SE = 0.02, 95% CI = 0.02-0.12). C-NRT mediation occurred via greater reduction in pre-post-TQD changes in craving (ab = 0.04, SE = 0.02, 95% CI = 0.01-0.08) and expectancies (ab = 0.03, SE = 0.02, 95% CI = 0.001-0.07), relative to patch monotherapy. CONCLUSION: Among adult smokers seeking to quit, varenicline seems to work through its effects on suppression of craving and smoking expectancies pre-cessation while combination nicotine replacement therapy mediation seems to work through cessation-related reduction in craving and smoking expectancies changes.

Smoking cessation intervention for patients with head and neck cancer: A prospective randomized controlled trial.

AIMS: To evaluate the effectiveness of a brief smoking cessation intervention in head and neck cancer patients (HNCP). STUDY DESIGN: A prospective randomized controlled trial that randomly assigns participants in two groups: a usual care group (UCG), and a standardized intervention group (SIG). MATERIAL AND METHODS: Patients with a confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) and who are active smokers were prospectively approached by one of 4 trained Ear-nose-throat (ENT) residents. Participants were randomized into a UCG, and a SIG consisting of a brief perioperative smoking cessation intervention based on National Institute of Health (NIH) "5A's" model along with an informative motivational document and nicotine patch therapy (NPT) offered for 8 weeks in gradually decreasing doses. OBJECTIVE: The evaluation of abstinence at 3, 6 and 12 months after enrollment. RESULTS: 56 subjects were randomized into the UCG (N = 29, 52%), and the SIG (N = 27, 48%). The overall smoking cessation rates were not statistically different between the two groups; we observed at 3 months cessation rates of 57.1% vs. 57.7% (p = 0.96); at 6 months, 42.9% vs. 24% (p = 0.148); and at 12 months, 33.3% vs. 20.8% (p = 0.318), for the UCG and the SIG respectively. CONCLUSION: This study failed to show the effectiveness of a combined brief smoking cessation approach led by and ENT resident in HNSCC patients. A multifaceted approach addressing different pharmacological treatments, factors contributing to smoking maintenance, mainly alcohol dependence and mood disturbances and dealing with relapse risks through close face-to-face or phone call follow-ups may have better outcomes and should be evaluated in upcoming trials.

Nicotine replacement therapy: A friend or foe.

According to the World Health Organization (WHO) Framework Convention for Tobacco Control (FCTC), tobacco cessation is a primary health-care service that should be provided not only to the people having adverse habits of consuming tobacco but also to the nonconsumer, as they can also be harmed due to its deleterious effects. Tobacco has been regarded as a potential risk factor for oral diseases such as oral potentially malignant disorders and oral cancers. Various aids of achieving cessation have been studied, including education of the ill effects of tobacco to the patient, behavioral counseling, and pharmacotherapy. Various pharmacological interventions are available nowadays but nicotine replacement therapy (NRT) is most widely used. The various types of NRT products results in general and breakthrough craving relief with immediate release of nicotine. All of these products have different levels of efficacy and variable rates of nicotine absorption. Knowledge of these will be beneficial for the patients, the budding dentist and the nation in the upcoming days ahead.

Evaluation of nicotine patch adherence measurement using self-report and saliva cotinine among abstainers in a smoking cessation trial.

BACKGROUND: Adherence to nicotine patches relates to cessation. This is the first study to examine the validity of self-reported nicotine patch adherence relative to saliva cotinine. METHODS: We used data from 198 clinical trial participants who received 11 weeks of nicotine patches, self-reported patch use, had saliva cotinine 1-week after the start of treatment assessed, and were not smoking when saliva was collected (CO < 6). Self-reported patch adherence was defined as: 3-day (before saliva collection), 7-day (before saliva collection), 3-week use (7 days before, and 14 days after, saliva collection), and 11-week use (7 days before, and 10 weeks after, saliva collection). Analyses, including receiver operating characteristic curves, considered differences in nicotine metabolism. Sensitivity, specificity and positive (PPV) and negative predictive value (NPV) assessed optimal cotinine cut-point for adherence. RESULTS: Self-reported 7-day (r = 0.13) and 3-week (r = 0.13) patch use marginally correlated with week 1 cotinine (p's = 0.08) but not 3-day or 11-week. Significant area under the curve (AUC) values of 0.67 (95 %CI: 0.55-0.79) and 0.72 (95 %CI: 0.57-0.88) were found using 7-day self-report for the overall sample and for slow metabolizers (p's<0.01), but not for normal metabolizers. Optimal 1-week cotinine cut-points using 7-day self-report were 170 ng/mL (overall) and 184 ng/mL (slow), with sensitivity = 0.56-0.62, specificity = 0.69-0.78, PPV = 0.96-0.97, and NPV = 0.13-0.14. CONCLUSIONS: Among CO-confirmed abstainers, self-reported patch use and saliva cotinine assessed 1-week into treatment, were modestly correlated and optimal cotinine cut-point differed by rate of nicotine metabolism. Seven-day patch use may be a more valid self-report measure of patch adherence based on cotinine than 3-day, 3-week, or 11-week. Rate of nicotine metabolism may affect this relationship.

Death related to nicotine replacement therapy: A case report.

Transdermal nicotine patches and nicotine tablets are widely used for substitution therapies after cessation of smoking. Toxic concentrations of nicotine and cotinine, its main metabolite, are rarely reported, either in cases of misuse or in a fatal context. We report here a rare fatal case due to massive exposure to nicotine replacement therapy. A 41-year-old man was found dead by his cellmate with 7 nicotine patches on the body. There were 14 nicotine patches (21 mg) and 5 empty blisters of nicotine tablets (Nicopass® 1.5 mg) in the bin. External, internal, and histological examinations revealed asphyxia syndrome. Toxicological analyses indicated lethal concentrations of nicotine and cotinine in femoral (2239 and 1230 ng/mL) and cardiac blood (1344 and 1090 ng/mL). Screening for ethanol, drugs, and illicit drugs revealed therapeutic concentrations of cyamemazine, lormetazepam, nordiazepam, oxazepam, and buprenorphine and its metabolite. THC and its metabolites were also detected, reflecting use of cannabis. The findings highlight the risk of nicotine poisoning in persons using nicotine patches. This case emphasises the importance of carrying out complete toxicological analyses to prevent other instances of nicotine poisoning from being overlooked.

Effectiveness of transdermal nicotine patch in premenopausal female smokers is moderated by within-subject severity of negative affect and physical symptoms.

RATIONALE: Nicotine patches may be less effective in female compared with male smokers. However, it is unknown if negative affect and physical symptoms influence transdermal nicotine patch-related effects on smoking behaviors. METHODS: Eighty-one acutely tobacco-abstinent premenopausal female smokers attended three counter-balanced experimental sessions across the menstrual cycle (early follicular, late follicular, and mid-luteal) and were randomized to patch condition (nicotine [21 mg] vs. placebo [0 mg] transdermal patch). Negative affect and physical symptoms were assessed prior to patch administration. The patch was removed 5 h post-administration, and participants completed a smoking reinstatement task. Multilevel linear models tested associations of patch condition, negative affect and physical symptoms, and their interaction on smoking behavior. RESULTS: There was a significant patch condition × Negative Affect and Pain symptoms interaction on the number of cigarettes smoked (p < 0.05). When Negative Affect and Pain were lower-than-usual, females administered a nicotine patch smoked significantly fewer cigarettes than females administered a placebo patch (p < .05), but there were no significant patch differences when Negative Affect and Pain were higher-than-usual. There was also a significant patch condition × Negative Affect interaction on time delay. The effects of patch condition on time delay to smoking were greater during sessions in which Negative Affect was higher-than-usual. CONCLUSIONS: Results suggest that among female smokers transdermal nicotine patch effectiveness may interact with negative affect and pain. Understanding and considering female-specific factors that may impact the efficacy of one of the most commonly used cessation medications is important for improving smoking cessation in female smokers.

Combined nicotine patch with gum versus nicotine patch alone in smoking cessation in Hong Kong primary care clinics: a randomised controlled trial.

BACKGROUND: The prevalence of daily cigarette smoking has dropped to 10% in Hong Kong (HK) in 2017, however, smoking still kills 5700 persons per year. Studies suggest that abstinence rates are higher with combined NRT than single NRT, although local data on safety and benefits of combined NRT are lacking. The aim of this study is to compare the effectiveness of combined NRT with single NRT among HK Chinese. METHODS: This is a one-year, two-arm, parallel randomised trial. Five hundred sixty smokers, who smoked ≥10 cigarettes/day for ≥1 year, were randomized to combined and single NRT. Combined NRT group received counseling and nicotine patch & gum. Single NRT group received counselling and nicotine patch. Primary outcome was abstinence rate measured as self-reported 7-day point prevalence with CO validated at 52 weeks. Secondary outcomes included smoking abstinence rates at 4, 12, & 26 weeks. Crude odds ratio and p-value were reported from logistic regression without adjustment; for trend analysis, adjusted odds ratio (AOR) and p-value were reported from Generalized Estimating Equation (GEE) (controlling for time). All AORs were adjusted for age, sex, baseline CO and clusters. RESULTS: Abstinence rates at 4, 12, 26 and 52 weeks were all higher in the combined NRT group (35.8, 21.9, 16.8, 20.1%) compared with the single NRT group (28, 16.8, 11.2, 14.3%). At 4 weeks, combined NRT group was more likely to quit smoking (OR 1.43, 95% CI, 1.00 to 2.05) than the single NRT group. From GEE analysis, combined NRT group had a significantly higher abstinence rate (23.6%) than the single NRT group (17.6%) across repeated measures at all-time points. Combined NRT group was more likely to quit smoking (OR 1.43, 95% CI, 1.15 to 1.77). No significant difference in the side effect profile was detected between groups. CONCLUSIONS: Smokers given 8 weeks of combined NRT were more likely to quit smoking at 4, 12, 26 and 52 weeks compared with single NRT. Combined NRT was as well tolerated as single NRT and it should be further promoted in our community. TRIAL REGISTRATION: NCT03836560 from ClinicalTrial.gov , 9 Feb 2019.

Effectiveness and safety of nicotine patches combined with e-cigarettes (with and without nicotine) for smoking cessation: study protocol for a randomised controlled trial.

INTRODUCTION: Evidence indicates e-cigarettes can help people quit smoking; however, more confirmatory trials are needed. To date, no trials have evaluated the effectiveness and safety of combining nicotine patches with e-cigarettes (with and without nicotine) for smoking cessation. METHODS AND ANALYSIS: This study is a pragmatic, three-arm, community-based, single-blind, randomised trial undertaken in New Zealand. Eligible participants are daily/non-daily smokers, aged ≥18 years, naive e-cigarette users and motivated to quit smoking in the next 2 weeks. Participants (n=1809), recruited using multi-media advertising, are randomised to 14 weeks of (1) 21 mg nicotine patches (n=201); (2) 21 mg nicotine patches+18 mg/mL nicotine e-cigarette (n=804); or (3) 21 mg nicotine patches+nicotine free e-cigarette (n=804). Participants receive weekly withdrawal-oriented behavioural support calls for 6 weeks post-randomisation. The primary outcome is self-reported biochemically verified continuous abstinence (CA) at 6 months post quit-date. The primary comparison is nicotine patch + nicotine e-cigarette versus nicotine patch + nicotine free e-cigarette, and the secondary comparison is nicotine patch versus nicotine patch +nicotine e-cigarette (90% power, p=0.05, to detect an absolute difference in 6 month CA rates of 8% and 15% respectively). Secondary outcomes, collected by phone interview at quit date, then 1, 3, 6 and 12 months post-quit date, include self-reported CA, 7 day point prevalence abstinence, cigarettes per day (if smoking, or when smoking for non-daily smokers), time to relapse (if returned to smoking), belief in ability to quit, use of other cessation support, side effects/serious adverse events, treatment compliance, seeking additional support around e-cigarette use, daily use of both e-cigarettes and cigarettes, use of treatment past 14 weeks, views on treatment and recommendation to others, weight and cost-per-quitter. ETHICS AND DISSEMINATION: The Northern A Health and Disability Ethics Committee approved the trial. Findings will be disseminated through publication, conference/meeting presentations, and media. TRIAL REGISTRATION NUMBER: NCT02521662; Pre-results.

Ten-year experience of smoking cessation in a single center in Japan.

BACKGROUND: Long-term, real-world data, as opposed to academic or research data, on outcomes of smoking cessation clinics are scarce. We assessed patient outcomes over a 10-year period at a smoking cessation clinic in a community teaching hospital in Japan and explored predictors of successful smoking cessation. METHODS: We used data from a prospective registry of cigarette smokers who participated in a 3-month smoking cessation program comprising combined pharmacological treatment and cognitive behavioral therapy and explored factors associated with program execution and successful smoking cessation. The primary outcome was smoking cessation, defined by quitting completely between the 8-week and 12-week sessions, with verification according to exhaled carbon monoxide (CO) level of ≤10 ppm. RESULTS: Between August 2007 and December 2017, 813 patients with nicotine dependence participated in the program. The number of participants decreased after Japan׳s 2010 tobacco tax increase. Among participants, 433 (53.3%) completed the program. In multivariate analysis, the number of cigarettes smoked daily (odds ratio [OR] 0.98, 95% confidence interval [CI] 0.96, 0.99), cardiovascular disease (OR 1.75, 95% CI 1.16, 2.68), chronic obstructive pulmonary disease (OR 1.74, 95% CI 1.10, 2.78), and gastric/duodenal ulcer (OR 1.77, 95% CI 1.04, 3.08) were significantly associated with program completion. Among program completers, 288 (66.5%) achieved smoking cessation. Exhaled CO level (OR 0.94, 95% CI 0.93, 0.97) and mental disorders (OR 0.53, 95% CI 0.33, 0.85) were negatively associated with successful smoking cessation. CONCLUSIONS: Baseline exhaled CO level and mental disorders were significantly associated with either success or failure of smoking cessation.

Short-Term Safety of Nicotine Replacement in Smokers Hospitalized With Coronary Heart Disease.

Background Little is known about the safety of nicotine replacement therapy ( NRT ) in smokers hospitalized with coronary heart disease. Methods and Results We examined the short-term safety of NRT use among smokers hospitalized for coronary heart disease in a geographically and structurally diverse sample of US hospitals in the year 2014. We compared smokers who started NRT in the first 2 days of hospitalization with smokers without any exposure to NRT and adjusted for baseline differences through propensity score matching. Outcomes included inpatient mortality, hospital length of stay, and 1-month readmission. From 270 hospitals, we included 27 459 smokers (mean age, 58 years; 69% men; 56.9% in intensive care unit), of whom 4885 (17.8%) received NRT (97.2% used the nicotine patch, at a median dose of 21 mg/d for 3 days). After propensity matching, covariates were well balanced within each patient group. Among patients with myocardial infarction, compared with patients who did not receive NRT , those who received NRT showed no difference in mortality (2.1% versus 2.3%; P=0.98), mean length of stay (4.4±3.5 versus 4.3±3.3 days; P=0.60), or 1-month readmission (15.8% versus 14.6%; P=0.31). Results were similar for patients undergoing percutaneous coronary intervention or coronary artery bypass surgery. Conclusions Among smokers hospitalized for treatment of coronary heart disease, use of NRT was not associated with any differences in short-term outcomes. Given the known beneficial effects of NRT in treating nicotine withdrawal, reducing cravings, and promoting smoking cessation after discharge, our findings suggest that NRT is a safe and reasonable treatment option.

Long-term smoking cessation rates in elderly versus other adult smokers: A 3-year follow-up study in Taiwan.

INTRODUCTION: Smoking cessation improves life expectancy at any age. There is some evidence that elderly smokers have at least as good a chance of successfully stopping as other smokers but direct comparisons with long-term follow up are rare. This study aimed to compare success rates up to 3 years in smokers aged 65+ versus other adult smokers with and without adjustment for a range of other smoker characteristics. METHODS: This was a prospective study of 1065 smokers who attended a stop-smoking clinic in Taiwan. Participants (896 < 65 years, 169 65+ years) were followed up by telephone 3, 6, 12 and 36 months after the initial quit date. Prolonged abstinence (abstinent at all follow-ups) and point prevalence abstinence (7 days prior to final follow up) were compared between 'elderly' participants aged 65+ years versus 'non-elderly' participants aged <65 years with and without adjustment for a range of baseline smoker characteristics (sex, educational level, previous quit attempts, cigarette dependence score). Non-responders were considered to be smoking. RESULTS: Prolonged 36-month abstinence rates were 20.1% (N = 34) and 15.3% (N = 137) in the elderly and non-elderly participants respectively (p = 0.137). Point prevalence 36-month abstinence rates were 37.3% (N = 63) and 26.5% (N = 237) in the elderly and non-elderly participants respectively (p = 0.005). The odds ratios comparing elderly versus non-elderly abstinence rates after adjustment for baseline variables were 1.17 (95%CI = 0.75-1.83) and 1.52 (95%CI = 1.05-2.20) for prolonged abstinence and point prevalence abstinence respectively. CONCLUSIONS: Elderly smokers attending smoker clinics in Taiwan appear to be at least as likely to achieve long-term abstinence as other adult smokers.

High-dose transdermal nicotine in Parkinson's disease patients: a randomized, open-label, blinded-endpoint evaluation phase 2 study.

BACKGROUND AND PURPOSE: Studies of the effects of nicotine on motor symptoms in Parkinson's disease (PD) brought out discordant results. The aim of the present study was to evaluate the efficacy and safety of high doses of transdermal nicotine on motor symptoms in PD. METHODS: Forty PD patients were randomly assigned to a treated and untreated arm in an open-label study. Treated patients received increasing doses of nicotine to reach 90 mg/day by 11 weeks. This dosage was maintained for 28 weeks (W39) and then reduced over 6 weeks. Final evaluation was performed 6 weeks after washout. The main outcome measure was the OFF-DOPA Unified Parkinson's Disease Rating Scale (UPDRS) motor score measured on video recordings by raters blinded to the medication status of the patients. RESULTS: There was no significant difference in OFF-DOPA UPDRS motor scores between the nicotine-treated and non-treated groups, neither at W39 (19.4 ± 9.3 vs. 21.5 ± 14.2) nor considering W39 differences from baseline (-1.5 ± 12.1 vs. +0.9 ± 12.1). The 39-item Parkinson's disease questionnaire scores decreased in nicotine-treated patients and increased in non-treated patients, but the difference was not significant. Overall tolerability was acceptable, and 12/20 treated patients reached the maximal dosage. CONCLUSIONS: High doses of transdermal nicotine were tolerated, but our study failed to demonstrate significant improvement in UPDRS motor scores. Improvement in unblinded secondary outcomes (UPDRS-II, UPDRS-IV, doses of l-DOPA equivalents) suggest a possible benefit for patients treated with nicotine, which should be confirmed in larger double blind, placebo-controlled studies.

Effectiveness of continuing nicotine replacement after a lapse: A randomized trial.

INTRODUCTION: Four post-hoc analyses of prior trials found smokers using nicotine patch following a lapse were less likely to progress to relapse compared to those using a placebo patch following a lapse. We attempted a conceptual replication test of these results via a randomized trial of instructions to continue vs. stop nicotine patch after a lapse. METHODS: Smokers trying to quit (n=701) received nicotine patch (21/14/7mg) and brief phone counseling (six 15-min sessions). We randomized smokers to receive instructions for and rationale for stopping vs. continuing patch after a lapse. The messages were repeated before and after cessation and following lapses via counseling, phone and written instructions. RESULTS: Among those who lapsed, those told to Continue Patch did not have a greater incidence of 7-day abstinence at 4months (primary outcome) than those told to Discontinue Patch (51% vs. 46%). Most (81%) participants in the Discontinue condition stopped patch for only 1-2days and then resumed abstinence and patch use. Analyses based on all participants randomized were similar. Adverse events were as expected and did not differ between conditions. CONCLUSION: Instructions to continue nicotine patch after a lapse did not increase return to abstinence. These negative results may have occurred because actual use of patch after a lapse was similar in the two conditions. Also, allowing patch use while smoking may have reduced motivation to stay abstinent.