Nicotine Replacement Therapy Patch Research Articles

Economic Evaluation of Enhanced vs Standard Varenicline Treatment for Tobacco Cessation

Smoking is the leading preventable cause of death and illness in the US. Identifying cost-effective smoking cessation treatment may increase the likelihood that health systems deliver such treatment to their patients who smoke. To evaluate the cost-effectiveness of standard vs enhanced varenicline use (extended varenicline treatment or varenicline in combination with nicotine replacement therapy) among individuals trying to quit smoking. This economic evaluation assesses the Quitting Using Intensive Treatments Study (QUITS), which randomized 1251 study participants who smoked into 4 conditions: (1) 12-week varenicline monotherapy (n = 315); (2) 24-week varenicline monotherapy (n = 311); (3) 12-week varenicline combination treatment with nicotine replacement therapy patch (n = 314); or (4) 24-week varenicline combination treatment with nicotine replacement therapy patch (n = 311). Study enrollment occurred in Madison and Milwaukee, Wisconsin, between November 11, 2017, and July 2, 2020. Statistical analysis took place from May to October 2023. The primary outcome was 7-day point prevalence abstinence (biochemically confirmed with exhaled carbon monoxide level ≤5 ppm) at 52 weeks. The incremental cost-effectiveness ratio (ICER), or cost per additional person who quit smoking, was calculated using decision tree analysis based on abstinence and cost for each arm of the trial. Of the 1251 participants, mean (SD) age was 49.1 (11.9) years, 675 (54.0%) were women, and 881 (70.4%) completed the 52-week follow-up. Tobacco cessation at 52 weeks was 25.1% (79 of 315) for 12-week monotherapy, 24.4% (76 of 311) for 24-week monotherapy, 23.6% (74 of 314) for 12-week combination therapy, and 25.1% (78 of 311) for 24-week combination therapy, respectively. The total mean (SD) cost was $1175 ($365) for 12-week monotherapy, $1374 ($412) for 12-week combination therapy, $2022 ($813) for 24-week monotherapy, and $2118 ($1058) for 24-week combination therapy. The ICER for 12-week varenicline monotherapy was $4681 per individual who quit smoking and $4579 per quality-adjusted life-year (QALY) added. The ICER for 24-week varenicline combination therapy relative to 12-week monotherapy was $92 000 000 per additional individual who quit smoking and $90 000 000 (95% CI, $15 703 to dominated or more costly and less efficacious) per additional QALY. This economic evaluation of standard vs enhanced varenicline treatment for smoking cessation suggests that 12-week varenicline monotherapy was the most cost-effective treatment option at the commonly cited threshold of $100 000/QALY. This study provides patients, health care professionals, and other stakeholders with increased understanding of the health and economic impact of more intensive varenicline treatment options.

Testing the feasibility of the QuitAid smoking cessation intervention in a randomized factorial design in an independent, rural community pharmacy

BackgroundAdult smoking rates in the USA are highest in economically depressed rural Appalachia. Pharmacist-delivered tobacco cessation support that incorporates medication therapy management (such as the QuitAid intervention) is a promising approach to address this need.MethodsTwenty-four adult smokers recruited between September and November 2021 through an independent pharmacy in rural Appalachia were randomized in a non-blinded 2 × 2 × 2 factorial design to (1) pharmacist delivered QuitAid intervention (yes vs. no); (2) combination nicotine replacement therapy (NRT) gum + NRT patch (vs. NRT patch); and/or (3) 8 weeks of NRT (vs. standard 4 weeks). Participants received 4 weeks of NRT patch in addition to the components to which they were assigned. Participants completed baseline and 3-month follow-up assessments. Primary outcomes were feasibility of recruitment and randomization, retention, treatment adherence, and fidelity.ResultsParticipants were recruited in 7 weeks primarily through a referral process, commonly referred to as ask-advise-connect (61%). Participants were on average 52.4 years old, 29.2% were male and the majority were white (91.6%) and Non-Hispanic (91.7%). There was a high level of adherence to the interventions, with 85% of QuitAid sessions completed, 83.3% of the patch used, and 54.5% of gum used. Participants reported a high level of satisfaction with the program, and there was a high level of retention (92%).ConclusionsThis demonstration pilot randomized controlled study indicates that an ask-advise-connect model for connecting rural smokers to smoking cessation support and providing QuitAid for smoking cessation is feasible and acceptable among rural Appalachian smokers and independent pharmacists. Further investigation into the efficacy of a pharmacist-delivered approach for smoking cessation is needed.Trial registrationThe trial was retrospectively registered at ClinicalTrials.gov. Trial #: NCT05649241.

Evaluating Smoking Cessation Counseling Bundle Behavioral Intervention for Mongolian Adults Who Use Nicotine Patches

Objectives: The objective of this study is to evaluate the effectiveness of a behavioral intervention based on the World Health Organization (WHO) 5A and 5R guidelines in Mongolia who use the Nicotine Replacement Therapy (NRT) patch. The study aims to assess the impact of the intervention on smoking cessation rate. The finding of this study will contribute to the existing literature on smoking cessation interventions and provide valuable insights into the effectiveness of a behavioral approach in a Mongolian population. Methods: In the intervention study, out of total of 806 people interested in the part of this study. The study team excluded their eligibility criteria of the study participant. A sample of 625 people who fulfilled study inclusion criteria received advice about the negative consequences of tobacco. After that, 479 people decided to quit smoking and 41 people were excluded due to health contraindications, and the final sample 454 people began nicotine replacement therapy to quit smoking. Participants in the treatment group received nicotine replacement patches for 28 days, while those in the counseling group received four sessions of behavioral change counseling (5A, 5R). Results: 454 were found to be eligible to take part in the study and were subsequently assigned to one of two groups, with 230 and 224 participants assigned to each group, respectively. In the second month of follow-up, 90 (39.1%) of participants who received NRT patches quit smoking. The group that received NRT + Behavioral intervention was 1.02 times as successful, or 0.7% more effective, than the group that did not receive behavioral intervention (P=0.872). Conclusion: WHO 5A, 5R brief counselling were more effective than group without behavioral intervention for smoking cessation, but difference was insignificant.

Comparative effect of varenicline and nicotine patches on preventing repeat cardiovascular events

ObjectiveTo determine the comparative effectiveness of postdischarge use of varenicline versus prescription nicotine replacement therapy (NRT) patches for the prevention of recurrent cardiovascular events and mortality and whether this association...

Learning to quit: can reinforcement theories predict the success of smoking cessation attempts using nicotine replacement therapy patches in a general population sample of smokers at 8-weeks and 6-months follow-up?

ABSTRACT Primary, secondary, and tertiary reinforcement contribute to the maintenance of smoking behaviour and may influence the efficacy of different cessation treatments. This analysis examined these relationships in a large general population sample and investigated how previous experiences of the different reinforcement mechanisms impacted future quit attempts. Random digit telephone dialing was used to recruit a sample of Canadian adults who smoked and were interested in being part of a hypothetical program that would provide nicotine replacement therapy (NRT) patches free by mail and half of the eligible participants were randomized to actually receive a five-week supply of NRT patches. During the interviews, reasons for relapse to smoking during previous quit attempts were collected and coded by two reviewers (disagreements were settled by a third reviewer). Binary logistic regression was used to determine if type of reinforcer moderated the intervention effect of the patches. Participants who made cessation attempts in the past year were more likely to report negative (p = .039), secondary (p = .041), and tertiary (p = .010) reinforcers and less likely to report positive reinforcers (p = .016) compared to those who did not attempt to quit. Logistic regressions revealed no significant conditional effects of the intervention on the relationship between reinforcer type and quit attempts or 30-day smoking abstinence. Analysis including all three reinforcers showed negative reinforcers decreased but tertiary reinforcers increased the odds participants reported a cessation attempt before the baseline interview and between baseline and 8-weeks. Understanding the different ways nicotine reinforces smoking behaviour could help guide individuals to more effective treatment options.

Publicly subsidised smoking cessation medicines in times of COVID-19 in Australia: An interrupted time series analysis.

In Australia, the available published literature demonstrated a spike in dispensed prescription medicines after the onset of the COVID-19 pandemic that subsequently returned to expected levels. Smoking cessation medicines may not follow this pattern because quit attempts are influenced by a range of factors. Knowledge of whether dispensing of these medicines has changed since the pandemic is lacking. We explored the change in dispensing of publicly subsidised smoking cessation medicines since the pandemic. Australia's universal health-care system provides access to government-subsidised medicines via the Pharmaceutical Benefits Scheme and records of dispensed medicines are publicly available on a nationally aggregated level. We retrieved Pharmaceutical Benefits Scheme data from January 2016 to January 2021. We used interrupted time series modelling to quantify the impact of COVID-19 on dispensing of nicotine replacement therapy (NRT) patches, varenicline and all smoking cessation treatments combined separately. After an initial spike in medicines at the onset of the pandemic, the monthly rate of prescriptions dispensed for varenicline was predominantly within predicted ranges, while that of NRT patches was predominantly below predicted ranges. There has been a differential change in the number of subsidised smoking cessation medicines supplied in Australia since the COVID-19 pandemic, with varenicline prescriptions largely within, and NRT patches largely lower than, expected ranges. The reasons for the apparent change in dispensing of subsidised smoking cessation medicines are unclear.

Uptake of prescription smoking cessation pharmacotherapies after hospitalization for major cardiovascular disease.

We determined the prevalence of prescription smoking cessation pharmacotherapy (SCP) use after hospitalization for major cardiovascular disease (MCD) among people who smoke and whether this varies by sex. We conducted a population-based cohort study including all people hospitalized in New South Wales, Australia, between July 2013 and December 2018 (2017 for private hospitals) with an MCD diagnosis. For patients who also had a diagnosis of current tobacco use, we used linked pharmaceutical dispensing records to identify prescription SCP dispensings within 90 days post-discharge. We determined the proportion who were dispensed an SCP within 90 days, overall and by type of SCP. We used logistic regression to estimate the odds of females being dispensed an SCP relative to males. Of the 150 758 patients hospitalized for an MCD, 20 162 (13.4%) had a current tobacco use diagnosis, 31% of whom were female. Of these, 11.3% (12.4% of females, 10.9% of males) received prescription SCP within 90 days post-discharge; 3.0% were dispensed varenicline, and 8.3% were dispensed nicotine replacement therapy patches. Females were more likely than males to be dispensed a prescription SCP [odds ratio (OR) 1.16, 95% confidence interval (CI) 1.06-1.27)]; however, this was not maintained after adjusting for potential confounders (adjusted OR 1.04, 95% CI 0.94-1.15). Very few females and males who smoke use prescription SCPs after hospitalization for an MCD. The use of varenicline, the SCP with the highest efficacy, was particularly low. This represents a missed opportunity to increase smoking cessation in this high-risk population, thereby reducing their risk of recurrent cardiovascular events.

Comparison of Cardiovascular Safety for Smoking Cessation Pharmacotherapies in a Population-Based Cohort in Australia

Although concerns exist regarding a potential increased risk of cardiovascular events for smoking cessation pharmacotherapies, there is general consensus that any increased risk associated with their use would be outweighed by the benefits of smoking cessation; thus, clinical guidelines recommend that such pharmacotherapies be offered to everyone who wants to quit smoking. In the interest of minimizing risk to patients, prescribers need evidence indicating how these pharmacotherapies compare with one another in terms of cardiovascular safety. To compare the risk of major adverse cardiovascular events (MACE) among individuals initiating varenicline, nicotine replacement therapy (NRT) patches, or bupropion. This retrospective, population-based cohort study using linked pharmaceutical dispensing, hospital admissions, and death data was conducted in New South Wales, Australia. Participants included adults who were dispensed a prescription smoking cessation pharmacotherapy between 2008 and 2015 or between 2011 and 2015, depending on the availability of the pharmacotherapies being compared. Pairwise comparisons were conducted for risk of MACE among 122 932 varenicline vs 92 148 NRT initiators; 342 064 varenicline vs 10 457 bupropion initiators; and 102 817 NRT vs 6056 bupropion initiators. First course of the smoking cessation pharmacotherapy of interest. The primary outcome was MACE, defined as a composite of acute coronary syndrome, stroke, and cardiovascular death. Secondary outcomes were the individual components of MACE. Inverse probability of treatment weighting with high-dimensional propensity scores was used to account for potential confounding. Cox proportional hazards regression models with robust variance were used to estimate hazard ratios (HRs) and 95% CIs. Data were analyzed January 24, 2019, to September 1, 2021. The mean (SD) age of included individuals ranged from 41.9 (14.2) to 49.8 (14.9) years, and the proportion of women ranged from 42.8% (52 702 of 123 128) to 52.2% (53 693 of 102 913). The comparison of 122 932 varenicline initiators and 92 148 NRT patch initiators showed no difference in the risk of MACE (HR, 0.87; 95% CI, 0.72-1.07) nor in the risk of the secondary outcomes of acute coronary syndrome (HR, 0.96; 95% CI, 0.76-1.21) and stroke (HR, 0.72; 95% CI, 0.45-1.14). However, decreased risk of cardiovascular death was found among varenicline initiators (HR, 0.49; 95% CI, 0.30-0.79). The results of comparisons involving bupropion were inconclusive owing to wide confidence intervals (eg, risk of MACE: 342 064 varenicline vs 10 457 bupropion initiators, HR, 0.87 [95% CI, 0.53-1.41]; 102 817 NRT patch vs 6056 bupropion initiators, HR, 0.79 [95% CI, 0.39-1.62]). The finding of this cohort study that varenicline and NRT patch use have similar risk of MACE suggests that varenicline, the most efficacious smoking cessation pharmacotherapy, may be prescribed instead of NRT patches without increasing risk of major cardiovascular events. Further large-scale studies of the cardiovascular safety of varenicline and NRT relative to bupropion are needed.

A tailored telehealth group tobacco cessation treatment program for people with HIV: Study protocol for a randomized controlled trial

BackgroundSmoking-related illnesses are the leading cause of death among people with HIV (PWH). Yet, there are few effective evidence-based interventions that help PWH quit smoking. The group-based program Positively Smoke Free is a biobehavioral cessation intervention for PWH with a growing evidence base. This study builds on prior work of Positively Smoke Free and addresses numerous weaknesses of prior trials for this population. We describe the Positively Quit Trial, a randomized controlled trial comparing a videoconferencing delivered Positively Smoke Free intervention to an attention-matched condition, assessing cessation over a 1-year period. MethodsThis attention-matched, randomized (1:1) controlled trial compares Positively Smoke Free Video-Groups to an updated version of Healthy Relationship Video-Groups. Participants are PWH, aged 18 years and older, who smoke at least one cigarette per day. All are offered nicotine replacement therapy patches and given brief advice to quit. Participants are enrolled in 12 group sessions focusing on either smoking cessation for PWH or broader topics regarding living healthy with HIV; in both conditions, Social Cognitive Theory is the guiding theoretical framework. Participants complete assessments at baseline, days 42, 90, 180, and 360; self-reported abstinence is verified with a video-observed cheek swab sent to a lab and tested for cotinine. Primary outcomesBiochemically confirmed 7-day point prevalence smoking abstinence at day 360 is the primary outcome. Cost per quit, sustained abstinence at various timepoints, and biochemical confirmed abstinence at three and six months are secondary outcomes. Effects of smoking cessation on CD4 and virologic suppression are also explored.

Do e-cigarette sales reduce the demand for nicotine replacement therapy (NRT) products in the US? Evidence from the retail sales data

Despite mixed evidence, many smokers use e-cigarettes to quit smoking. With the substantial growth of e-cigarette sales in recent years, it is important to understand how it may affect FDA-approved nicotine replacement therapy (NRT) products in the US. This study aims to investigate the impact of e-cigarette prices and TV advertising on the demand for NRT products. Quarterly (2010 Q1–2017 Q4) retail sales and price data of e-cigarettes and NRT gum and patch, compiled from Nielsen retail store scanner database, were linked with contemporaneous quarterly television rating data for e-cigarettes and NRT products, compiled from Kantar Media, using state and county identifier. Market, year, and quarter fixed effects models were used to estimate the impact of NRT price and TV advertising, as well as e-cigarette price and TV advertising, on the demand for NRT gum and patch. NRT gum price elasticity was estimated to be −0.91. Higher patch price was found to decrease gum sales (cross-price elasticity −0.96). Higher e-cigarette prices were found to decrease NRT gum sales. Higher cigarette prices were found to increase NRT gum sales. NRT patch price elasticity was estimated to be −2.05. Higher gum price was found to increase patch sales (cross-price elasticity 0.97). E-cigarette TV advertisement was positively associated with NRT gum sales. NRT gum appeared to be complements for e-cigarettes. Recent growth in e-cigarette sales may have increased the demand for NRT gum. More studies are needed to understand the differential behavioral patterns of NRT gum users and NRT path users.

Tobacco dependence management in a smoke-free inpatient drug and alcohol unit.

Various smoke-free policies and practices (carbon monoxide monitoring, nicotine replacement therapy, pharmacotherapy, behavioural interventions) have been introduced to manage tobacco dependence in inpatient drug and alcohol facilities. Since the introduction of a smoke-free policy to our inpatient drug and alcohol facility, there has been no objective evaluation of its practices or patients' views. We administered a questionnaire to 42 inpatients identified as smokers. A retrospective record review was performed on those patients for demographic data, substance use, psychiatric conditions and tobacco dependence assessment and management. Descriptive analyses and tests of association were conducted. Open-ended questions were subjected to content analysis. Tobacco dependence assessment was mostly completed with daily cigarette consumption documented for 41 (98%), time to first cigarette for 39 (93%) and CO monitoring performed for 42 (100%) patients. Patients' views of the various management strategies were positive, although many were underutilised. Those with high tobacco dependence were more likely to approve of nicotine replacement therapy patches than those with low tobacco dependence (p = 0.009). The results demonstrate that while the various interventions provided were reported to be helpful, many were underutilised. Future research could consider why certain strategies were not utilised and help improve uptake.

Efficacy and Safety of Pharmacotherapeutic Smoking Cessation Aids in Schizophrenia Spectrum Disorders: Subgroup Analysis of EAGLES.

This study aimed to evaluate the efficacy and safety of varenicline, bupropion, and nicotine replacement therapy (NRT) among smokers with schizophrenia spectrum disorders in post hoc analyses of Evaluating Adverse Events in a Global Smoking Cessation Study data. Smokers with schizophrenia spectrum disorder (N=390) and without a psychiatric illness (control group, N=4,028) were randomly assigned to receive varenicline, bupropion, NRT patch, or placebo for 12 weeks. Outcomes included abstinence rates during treatment and follow-up, number needed to treat (NNT) for abstinence, incidence of neuropsychiatric adverse events (NPSAEs), and temporal relationship between NPSAEs and abstinence status. Smokers with schizophrenia smoked more and had greater dependence and fewer prior trials of cessation pharmacotherapy at baseline. At each time point, smokers with schizophrenia assigned to varenicline had significantly greater odds of abstinence compared with their matched placebo group, with NNT comparable to the control group. Bupropion and NRT increased odds of abstinence; confidence intervals (CIs) included 1 for some comparisons, and NNT for smokers with schizophrenia was greater than for the control group. No treatment was associated with significantly more NPSAEs, compared with placebo, in either cohort. The estimated NPSAE rate was 5% (95% CI=3.0-7.7) for smokers with schizophrenia and 1% (95% CI=0.6-2.1) for the control group. Over one-third of NPSAEs occurred during partial or full abstinence, suggesting a multifactorial nature. For smokers with schizophrenia, varenicline led to significantly higher abstinence rates, and NNT was comparable to the control group. A significant proportion of NPSAEs occurred during early abstinence. No treatment significantly increased NPSAE prevalence.

Provision of free nicotine replacement therapy to parental smokers in the pediatric emergency setting.

INTRODUCTIONAlthough the administration of free Nicotine Replacement Therapy (NRT) is effective in helping smokers quit, the feasibility, acceptability and safety of this practice have not been examined in the emergency setting of the pediatric emergency department (PED) or urgent care (UC). We examined the characteristics of parental smokers who were interested and eligible for free NRT during their child’s emergency visit and the uptake, usage, and associated side effects of NRT use.METHODSWe analyzed data from 377 parental smokers who were randomized to receive cessation counseling and free NRT as part of an emergency visit-based randomized controlled trial. Parents interested in NRT were screened for medical contraindications; eligible parents were given a 6-week supply of NRT patches or lozenges during their child’s emergency visit and offered another supply 6 weeks later. We conducted Wilcoxon rank-sum tests and chi-squared tests to address our main study objective.RESULTSThe majority of parents were female (87.5%), non-Hispanic Black (52.5%), and mean (SD) age was 33.1 (8.2) years. A total of 252 (66.8%) parents were interested in receiving NRT. Compared to uninterested parents, interested parents were more likely to: be older [33.6 (8.2) vs 31.9 (8.2), years]; be non-Hispanic Black (54.0% vs 49.6%); have older children [5.5 (5.0) vs 4.2 (4.6)]; have a higher readiness to quit [7.0 (2.4) vs 5.2 (2.6)]; and have a child being evaluated in UC compared to the PED (72.4% vs 56.5%). A total of 53 (21%) interested parents had >1 NRT contraindications. At 6 weeks, 94 (79.0%) parents reported some ≥NRT usage and 50 (53.2%) requested an additional 6-week supply. There were no serious adverse events and 5 (5.3%) reported minor side effects.CONCLUSIONSParental smokers in the emergency setting are interested in receiving free NRT, the majority use it, and use is not associated with adverse side effects. The emergency visit may be an optimal time to offer NRT to parental smokers.

General practitioner and obstetrician views on system changes to improve smoking cessation care in pregnancy in Australia: a cross-sectional survey

AbstractIntroductionSystemic barriers impacting smoking cessation in pregnant women may include nicotine replacement therapy (NRT) access and training.AimAssess general practitioner (GP) and obstetrician's agreement with system-based changes to improve the management of smoking in pregnancy; compare group responses.MethodsNational cross-sectional survey with two samples: (1) online survey emailed to a random sample of 500 GPs from Royal Australian College of General Practitioners (RACGP); (2) paper survey posted to 5571 GPs and obstetricians from Royal Australia and New Zealand College of Obstetricians and Gynaecologists (RANZCOG). Percentages agreeing that specified changes would improve the management of smoking in pregnancy were calculated. Pairwise comparisons used Kruskal–Wallis tests (RACGP/RANZCOG GPs/obstetricians).ResultsN = 378 participated. Response rates 8.4% (N = 42; online survey) and 6% (N = 335; paper survey), respectively. Total percentages agreeing with system-based changes: 79% training, 64% oral NRT subsidy, 62% Medicare item for smoking cessation, 54% improved access to NRT patches. Within RANZCOG, more GPs (73.1%) agreed that oral NRT should be subsidised (P = 0.001) than obstetricians (53.7%).ConclusionGPs and obstetricians agreed that system changes would improve their management of smoking in pregnancy. Oral NRT subsidy was the only pairwise group difference. Subsequently, oral NRT has been subsidised; in time, this may influence prescribing and quit rates.

A Pilot Randomized Clinical Trial of Brief Interventions to Encourage Quit Attempts in Smokers From Socioeconomic Disadvantage.

Cigarette smoking disproportionately affects communities of low socioeconomic status where greater smoking prevalence and poorer cessation rates have been observed. Utilizing brief evidence-based interventions to increase cessation attempts may be an effective and easily disseminable means by which to mitigate undue burden in this population. The current intervention randomized daily smokers (N = 57) recruited from a local community soup kitchen to receive either Brief (eg, 30 m) Motivational Interviewing, Nicotine Replacement Therapy (NRT) sampling, or a Referral-Only intervention. Approximately half of participants (50.9%) reported not completing high school and many reported either just (41.4%) or not (40.4%) meeting basic expenses. Follow-up was completed approximately 1-month postintervention. Nonsignificant group differences indicated that participants randomized to the NRT sampling condition were more likely to make a quit attempt (moderate effect size). Approximately 40% of the sample reported making a serious quit attempt at follow-up. Significant differences in cigarettes per day at follow-up, controlling for baseline, were observed, with participants in the Motivational Interviewing condition, only, reporting significant reductions. Participants randomized to the NRT condition were significantly more likely to report using NRT patch and lozenge at follow-up (large effect). There were no differences between groups with respect to seeking behavioral support. Finally, we found that subjective financial strain moderated the effect of condition on change in cigarette consumption where NRT sampling was more effective for participants reporting less financial strain. Findings provide initial evidence for personalizing brief interventions to promote quit attempts in low-income smokers. While most clinical research on tobacco use and dependence focuses on successful sustained abstinence, the current study is novel because it examined three brief interventions designed to increase the number of quit attempts made by a nontreatment-seeking group suffering from health disparities (ie, smokers from socioeconomic disadvantage). These data suggest that nontreatment-seeking smokers from socioeconomic disadvantage can be influenced by Brief MIs and these interventions should be used to motivate smokers from socioeconomic disadvantage to make a quit attempt. Future studies should examine combined MIs including pharmacological and behavioral interventions.

Is the apparently protective effect of maternal nicotine replacement therapy (NRT) used in pregnancy on infant development explained by smoking cessation?: secondary analyses of a randomised controlled trial

ObjectiveTo investigate relationships between maternal smoking status in pregnancy and infant development. The largest randomised controlled trial of nicotine replacement therapy (NRT) for smoking cessation in pregnancy, the smoking, nicotine...

Healthcare Costs of Smokers Using Varenicline Versus Nicotine-Replacement Therapy Patch in the United States: Evidence from Real-World Practice.

IntroductionVarenicline (VAR) is an effective smoking-cessation therapy compared to the commonly used nicotine-replacement therapy patch (NRT-P). However, comparative real-world evidence on smoking-cessation therapies is limited, especially for economic outcomes.MethodsUsing national claims databases (2012–2016) in the United States (US), adults initiating VAR or NRT-P without use of any other smoking-cessation products were followed for up to 1 year on a quarterly basis. Outcomes included smoking-attributable (SA) (cardiovascular, diabetes, pulmonary diseases, and smoking cessation) and all-cause costs (2017 US dollars). Adjusted mean costs were estimated from multivariable regressions, with baseline characteristics and propensity scores as covariates. Annual adjusted costs were calculated from quarterly averages.ResultsThe VAR cohort (n = 209,284) was younger (mean age 46.7 vs. 49.0 years) and had fewer comorbidities [mean Charlson Comorbidity Index (CCI): 0.8 vs. 1.6] than the NRT-P cohort (n = 34,593). After adjustment, VAR cohort had lower SA and all-cause medical costs than NRT-P cohort in Quarters 1–4 (Q1–Q4) of follow-up, and had lower SA and all-cause total costs in Q2–Q4. Annually, VAR cohort had higher SA total costs ($307) and lower all-cause costs (− $2089) than NRT-P cohort. Annual medical costs were lower in VAR cohort (− $640 for SA and − $2876 for all-cause), and pharmacy costs were higher ($762 for SA and $777 for all-cause). In adherent patients (VAR: n = 38,744; NRT-P: n = 2702), VAR patients had lower annual medical costs (− $794 for SA and − $1636 for all-cause) and higher pharmacy costs ($1175 for SA and $1269 for all-cause); differences in SA and all-cause total costs were not statistically significant between treatment groups.ConclusionsLower SA and all-cause medical costs associated with the use of VAR versus NRT-P resulted in savings in all-cause total costs and, among adherent patients, potentially offset the high pharmacy costs of VAR.FundingPfizer, Inc.Electronic supplementary materialThe online version of this article (10.1007/s12325-018-0858-y) contains supplementary material, which is available to authorized users.

Constituents of "teabacco": A forensic analysis of cigarettes made from diverted nicotine replacement therapy lozenges in smoke-free prisons.

Following the implementation of prison smoke-free policies, there have been reports of prisoners creating substitute cigarettes made from nicotine replacement therapy patches or lozenges infused with tea leaves ("teabacco"). No studies have analyzed the chemical constituents of teabacco made from nicotine lozenges, so as to document any potential related health hazards. Teabacco samples were made by a participant who reported creating teabacco while incarcerated in a smoke-free prison in Queensland, Australia, and the process was video-recorded for replication in a laboratory. A simple linear smoking system captured the teabacco smoke for analysis. Inductively coupled plasma optical emission spectroscopy (ICP-OES) was used to analyze elemental composition and gas chromatography coupled with a mass spectrometer (GC-MS) analyzed the captured smoke using the National Institute of Standards and Technology mass spectral library. Analyses determined that quantities of copper, aluminum, and lead concentrations, and levels of inhaled total particulate matter, were above recommended guidelines for safe ingestion. Analysis of teabacco smoke using GC-MS identified potentially toxic compounds catechol and nicotine. However, our findings show that smoking this form of teabacco is less harmful than smoking teabacco made from nicotine patches, or smoking traditional tobacco cigarettes. Considering the limited potential health harm of smoking teabacco made from lozenges, and that nicotine lozenges represent the only form of smoking cessation support for individuals entering smoke-free prisons, we caution against the removal of nicotine lozenges from Queensland's prisons, at least until further research directly establishes health harms associated with this form of teabacco.

Anthropometric and body composition changes in smokers vs abstainers following an exercise-aided pharmacotherapy smoking cessation trial for women

IntroductionPost-cessation weight gain contributes to smoking relapse, especially for women. Furthermore, excess weight in the form of android or visceral fat is associated with metabolic health problems. For this study, a secondary analysis was conducted in 2015 to determine whether quitting status, achieved through a 14 week supervised exercise-aided nicotine replacement therapy (NRT) cessation program [Getting Physical on Cigarette Trial-2009 to 2013; Prapavessis, et al., 2016], affects anthropometric and body composition parameters in female smokers (N = 413, M age = 42.39 years). MethodsAnthropometric (weight and BMI) and body composition (% total body fat, % android fat, lean mass and visceral fat) indices were assessed at baseline and end of treatment. Smoking status was confirmed weekly from expired breath carbon monoxide. Adherence to exercise and NRT patch was calculated from the number of exercise sessions attended and patches worn to the number of exercise sessions offered and patches supplied, respectively. ResultsFactorial (smoking status) ANCOVAs controlling for baseline anthropometric and body composition parameters as well as adherence to exercise and NRT revealed significant differences in weight (p = .033; ɳp2 = 0.017) and BMI (p = .020; ɳp2 = 0.020) at week 14. This equated to abstainers weighing 1.26 kg more and having a 0.52 higher BMI than smokers. No significant differences were found for any of the body composition parameters at week 14 (ɳp2 range from 0.001–0.007). ConclusionsAbstainers gain modest weight compared to smokers. This weight gain is related to increases in lean mass and not total, android, or visceral fat.

Nicotine addiction management following surgery: a quality improvement approach in the post anesthesia care unit.

For smokers, hospital admission is accompanied by forced involuntary nicotine abstinence due to smoke-free site/grounds policies. An audit of patients admitted to our surgical wards revealed that identification of smoking status was inadequate and that nicotine addiction management (NAM) was infrequently offered. The project aimed to enhance both these metrics by initiating NAM in the post anesthesia care unit (PACU). Out of 744 patients admitted to our PACU in August 2015, 54% had their smoking status documented. The 200 patients (27%) out of the 744 were smokers and only 50% were offered NAM before discharge. PACU unit staff to determine the smoking status of every patient before discharge from the PACU (later changed to OR nursing staff) and, if a patient was identified as a smoker, to offer NRT (patch and mouth spray only) and initiate therapy prior to transfer of the patient to the ward. Data about number of patients admitted, presence of documented smoking status, number of identified smokers, and number offered/accepted nicotine replacement therapy (NRT) were collected at baseline and thereafter quarterly. Engaging video education sessions addressed the education gaps highlighted in a needs assessment. Identification of smoking status was made part of preoperative checklist and NRT was made available in post-operative recovery room. These interventions resulted in an increase in screening for tobacco use from 54% at baseline to 95% and the offer of NRT to smokers from 50 to 89%.