Nicotine Patch Research Articles

Changes in Smoking Cessation–Related Behaviors Among US Adults During the COVID-19 Pandemic

Smoking cessation is an urgent public health priority given that smoking is associated with increased risk of severe COVID-19 outcomes and other diseases. It is unknown how smoking cessation changed nationally during the COVID-19 pandemic. To investigate changes in smoking cessation-related behaviors in the US during the COVID-19 pandemic. This cross-sectional study was conducted using 2011 to 2020 data on 788 008 individuals who had smoked in the past year from the nationally representative Behavioral Risk Factor Surveillance System (BRFSS) survey. Representative retail scanner sales data between January 2017 and July 2021 for 1004 unique nicotine replacement therapy (NRT) universal product codes in 31 US states from NielsenIQ were also used. Calendar year and 4-week sales periods. Changes in annual self-reported prevalence of past-year quit attempts and recent successful cessation before (ie, 2011-2019) and during (ie, 2020) the COVID-19 pandemic and changes in sales volumes in millions of pieces of nicotine gum, lozenge, and patch brands before (1271 four-week sales periods between January 2017 and February 2020) and during (558 four-week sales periods between March 2020 and July 2021) the COVID-19 pandemic were calculated. The 2011 to 2020 pooled BRFSS sample (response rate range, 45.2%-49.9%) included 788 008 respondents (243 061 individuals ages 25-44 years [weighted percentage, 42.5%]; 374 519 men [weighted percentage, 55.7%]). For the first time since 2011, annual past-year quit attempt prevalence decreased between 2019 and 2020, from 65.2% (95% CI, 64.5% to 65.9%) to 63.2% (95% CI, 62.3% to 64.0%), with the largest relative decreases among individuals ages 45 to 64 years (61.4% [95% CI, 60.3% to 62.5%] vs 57.7% [95% CI, 56.3% to 59.2%]), those with 2 or more comorbidities (67.1% [95% CI, 66.0% to 68.2%] to 63.0% [95% CI, 61.6% to 64.4%]), and Black individuals (72.5% [95% CI, 70.3 to 74.6] vs 68.4% [95% CI, 65.3% to 71.3%]). Recent successful cessation remained unchanged during 2019 to 2020. Observed mean (SD) 4-week NRT sales volume in the prepandemic period was 105.6 (66.2) million gum pieces, 51.9 (31.6) million lozenges, and 2.0 (1.1) million patches. Compared with expected sales, observed sales during the COVID-19 pandemic were lower by 13.0% (95% CI, -13.7% to -12.3%) for lozenges, 6.4% (95% CI, -7.3% to -5.5%) for patches, and 1.2% (95% CI, -1.7% to -0.7%) for gum. This study found that serious smoking cessation activity among US adults decreased immediately and remained depressed for more than a year during the COVID-19 pandemic. These findings suggest that smokers experiencing disproportionately negative outcomes during the pandemic should be reengaged and assisted in quit attempts.

A Randomized Trial of Telephone-Based Smoking Cessation Treatment in the Lung Cancer Screening Setting.

Lung cancer mortality is reduced via low-dose computed tomography screening and treatment of early-stage disease. Evidence-based smoking cessation treatment in the lung screening setting can further reduce mortality. We report the results of a cessation trial from the National Cancer Institute's Smoking Cessation at Lung Examination collaboration. Eligible patients (n = 818) aged 50-80 years were randomly assigned (May 2017-January 2021) to the intensive vs minimal arms (8 vs 3 phone sessions plus 8 vs 2 weeks of nicotine patches, respectively). Bio-verified (primary) and self-reported 7-day abstinence rates were assessed at 3, 6, and 12 months post random assignment. Logistic regression analyses evaluated the effects of study arm. All statistical tests were 2-sided. Participants reported 48.0 (SD = 17.2) pack-years, and 51.6% were not ready to quit in less than 30 days. Self-reported 3-month quit rates were statistically significantly higher in the intensive vs minimal arm (14.3% vs 7.9%; odds ratio [OR] = 2.00, 95% confidence interval [CI] = 1.26 to 3.18). Bio-verified abstinence was lower but with similar relative differences between arms (9.1% vs 3.9%; OR = 2.70, 95% CI = 1.44 to 5.08). Compared with the minimal arm, the intensive arm was more effective among those with greater nicotine dependence (OR = 3.47, 95% CI = 1.55 to 7.76), normal screening results (OR = 2.58, 95% CI = 1.32 to 5.03), high engagement in counseling (OR = 3.03, 95% CI = 1.50 to 6.14), and patch use (OR = 2.81, 95% CI = 1.39 to 5.68). Abstinence rates did not differ statistically significantly between arms at 6 months (OR = 1.2, 95% CI = 0.68 to 2.11) or 12 months (OR = 1.4, 95% CI = 0.82 to 2.42). Delivering intensive telephone counseling and nicotine replacement with lung screening is an effective strategy to increase short-term smoking cessation. Methods to maintain short-term effects are needed. Even with modest quit rates, integrating cessation treatment into lung screening programs may have a large impact on tobacco-related mortality.

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.

Combining varenicline, nicotine patch reduces smoking in heavy‐drinking group

The Brown University Psychopharmacology UpdateVolume 33, Issue 8 p. 8-8 Research Roundup Combining varenicline, nicotine patch reduces smoking in heavy-drinking group First published: 05 July 2022 https://doi.org/10.1002/pu.30909Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat No abstract is available for this article. Volume33, Issue8August 2022Pages 8-8 RelatedInformation

Treatment use patterns in a large extended-treatment tobacco cessation program: predictors and cost implications

BackgroundTobacco dependence follows a chronic and relapsing course, but most treatment programmes are short. Extended care has been shown to improve outcomes. Examining use patterns for longer term programmes can...

Examining Attitudes, Expectations, and Tobacco Cessation Treatment Outcomes Among Incarcerated Tobacco Smokers.

People who are incarcerated have limited resources to help them quit tobacco smoking. This study assessed the association between baseline attitudes and expectations of the program with final smoking status as the outcome. A 6-week group-based counseling with nicotine patches was provided to incarcerated individuals to quit smoking. A cross-sectional survey was given at the first session. Questions surrounding attitudes such as interest, confidence, motivation, and expectations were used to assess associations with smoking cessation. Exhaled carbon monoxide (CO) levels were taken at each sessions. Participants were categorized as nonsmoking or continued smoking at a 6.0 parts per million (ppm) CO at their final session attended. Overall, 123 participants had a CO higher than 6.0 ppm or missed more than two sessions at their final session, and 54 had a CO under 6.0 ppm. A total of 102 participants completed the 6-week program. Differences among the two groups in exhaled CO began at Session 3 and continued throughout the study.

Nicotine patches in patients on mechanical ventilation for severe COVID-19: a randomized, double-blind, placebo-controlled, multicentre trial.

PurposeEpidemiologic studies have documented lower rates of active smokers compared to former or non-smokers in symptomatic patients affected by coronavirus disease 2019 (COVID-19). We assessed the efficacy and safety of nicotine administered by a transdermal patch in critically ill patients with COVID-19 pneumonia.MethodsIn this multicentre, double-blind, placebo-controlled trial conducted in 18 intensive care units in France, we randomly assigned adult patients (non-smokers, non-vapers or who had quit smoking/vaping for at least 12 months) with proven COVID-19 pneumonia receiving invasive mechanical ventilation for up to 72 h to receive transdermal patches containing either nicotine at a daily dose of 14 mg or placebo until 48 h following successful weaning from mechanical ventilation or for a maximum of 30 days, followed by 3-week dose tapering by 3.5 mg per week. Randomization was stratified by centre, non- or former smoker status and Sequential Organ Function Assessment score (< or ≥ 7). The primary outcome was day-28 mortality. Main prespecified secondary outcomes included 60-day mortality, time to successful extubation, days alive and free from mechanical ventilation, renal replacement therapy, vasopressor support or organ failure at day 28.ResultsBetween November 6th 2020, and April 2nd 2021, 220 patients were randomized from 18 active recruiting centers. After excluding 2 patients who withdrew consent, 218 patients (152 [70%] men) were included in the analysis: 106 patients to the nicotine group and 112 to the placebo group. Day-28 mortality did not differ between the two groups (30 [28%] of 106 patients in the nicotine group vs 31 [28%] of 112 patients in the placebo group; odds ratio 1.03 [95% confidence interval, CI 0.57–1.87]; p = 0.46). The median number of day-28 ventilator-free days was 0 (IQR 0–14) in the nicotine group and 0 (0–13) in the placebo group (with a difference estimate between the medians of 0 [95% CI -3–7]). Adverse events likely related to nicotine were rare (3%) and similar between the two groups.ConclusionIn patients having developed severe COVID-19 pneumonia requiring invasive mechanical ventilation, transdermal nicotine did not significantly reduce day-28 mortality. There is no indication to use nicotine in this situation.Supplementary InformationThe online version contains supplementary material available at 10.1007/s00134-022-06721-1.

The efficacy and safety of acupuncture and nicotine replacement therapy for smoking cessation: study protocol for a randomized controlled trial

IntroductionTobacco hazard is one of the most serious public health problems, accounting for up to 6 million deaths worldwide p.a. We aim to determine the efficacy and safety of acupuncture and/or nicotine replacement therapy on smoking cessation.MethodsWe will recruit 96 participants who are willing to quit smoking by acupuncture and/or nicotine replacement therapy in Chengguan, Xigu and Heping Districts, Lanzhou city, for multicenter randomized, double-blind, double-dummy controlled clinical trial. Following obtained the informed consent forms, all eligible participants will be randomly divided into 4 groups: (1) acupuncture combined with nicotine patch, (2) acupuncture combined with sham nicotine patch, (3) sham acupuncture combined with nicotine patch, and (4) sham acupuncture combined with sham nicotine patch. These participants will be treated with different intervention modalities for 8 weeks and then will be followed-up for 8 weeks. The SPSS 26.0 software will be applied to analyze the clinical effects and adverse reactions of different intervention measures for smoking cessation.DiscussionThis trial is a prospective, pragmatic, randomized, multicenter trial study protocol. The outcomes will illustrate the efficacy and safety of acupuncture and/or nicotine patches for smoking cessation. Provide smokers with a superior smoking cessation program.Trial registrationChinese Clinical Trial Registry ChiCTR2100042912. Registered on January 31, 2021.

Randomized Trial of a Web-Based Tobacco Treatment and Online Community Support for People With HIV Attempting to Quit Smoking Cigarettes.

Persons with HIV (PWH) in the United States (US) smoke cigarettes at approximately triple the rate of the general adult population and are less successful in their quit attempts than other smokers. This randomized trial tested whether a novel web-based cessation program for PWH yielded higher cigarette quit rates compared with a control program. Two urban HIV care sites in NYC and Baltimore. Between 2016 and 2020, 506 PWH were randomized to either Positively Smoke Free on the Web (PSFW+; N = 255), a multimodal platform, interactive web intervention hosted within an online social network to support quitting among PWH who smoke, and an attention-matched web-based control intervention (American Heart Association Getting Healthy; N = 251). All participants were offered 12 weeks of nicotine patch. Our primary outcome was biochemically confirmed exhaled carbon monoxide < 10 parts per million (ppm) 7-day point prevalence abstinence at 6 months. Participants were middle-aged (mean 50.2 years; range 23-73 years), 57% male, 19% Latinx, 83% Black, and 13% White. At 6 months, a significantly greater percentage of PSFW+ participants (14.9%) achieved biochemically confirmed 7-day point prevalence abstinence in intent-to-treat analysis compared with 8.8% of American Heart Association Getting Healthy participants [odds ratio =1.82 (95% confidence interval =1.04 to 3.18), P = 0.03]. PSFW+ is a promising cessation intervention composed of empirically tested content and real-time social support through an online social network that was found to promote abstinence. This digital approach has broad reach and scalability, can be easily integrated into comprehensive HIV care, and represents an advance in the fight against tobacco use among PWH.

Medication-assisted quit rates in participants with smoking-related diseases in EAGLES: Post hoc analyses of a double-blind, randomized, placebo-controlled clinical trial.

INTRODUCTIONGreater understanding is required of how smokers with smoking-related diseases respond to smoking cessation medications. This post hoc analysis of EAGLES data compared continuous abstinence rates (CARs) in smokers with/without smoking-related diseases and assessed participant demographic and baseline characteristics that may serve as predictors of continuous abstinence (CA).METHODSEAGLES was a 24-week (12-week treatment, 12-week follow-up), double-blind, active- (nicotine replacement therapy; patch) and placebo-controlled study in motivated-to-quit smokers with/without psychiatric disorders. This analysis assessed CARs at weeks 9-12 (CAR9-12) and 9-24 (CAR9-24) in participants with smoking-related diseases [asthma, chronic obstructive pulmonary disease (COPD), diabetes, and/or cardiovascular disease (n=1372)] versus controls without these comorbidities (n=6039). Participants received varenicline 1 mg twice daily, bupropion 150 mg twice daily, nicotine patches 21 mg/day with taper, or placebo for 12 weeks. Stepwise logistic modeling was also performed to analyze odds ratio (OR) for predictors of CA at weeks 9-12 (CA9-12) and 9-24 (CA9-24).RESULTSSmokers with smoking-related diseases were older, had a longer smoking history, more quit attempts, and were more likely to have a psychiatric disorder and reside in the US versus smokers without comorbidities. Fagerström Test for Cigarette Dependence scores and treatment adherence were comparable between cohorts. Smokers with smoking-related diseases had lower CARs versus controls (CAR9-12: 20.8% vs 24.0%; CAR9-24: 13.0% vs 16.9%). Use of smoking cessation medication was the strongest predictor of CA after control for demographics, smoking characteristics, and psychiatric disorder. By treatment, OR and CI were: varenicline CA9-12 (OR=3.82; 95% CI: 3.21-4.54) and CA9-24 (OR=2.92; 95% CI: 2.40-3.54); bupropion CA9-12 (OR=2.17; 95% CI: 1.81-2.60) and CA9-24 (OR=1.99; 95% CI: 1.63-2.44); nicotine patches CA9-12 (OR=2.23; 95% CI: 1.87-2.67) and CA9-24 (OR=1.86; 95% CI: 1.52-2.28).CONCLUSIONSSmokers with smoking-related diseases had lower quit rates than controls. Of the active treatments compared, varenicline was most effective in smokers with asthma, COPD, diabetes, or cardiovascular disease.TRIAL REGISTRATIONNCT01456936 (https://clinicaltrials.gov/ct2/show/NCT01456936).

Electronic cigarettes versus nicotine patches for smoking cessation in pregnancy: a randomized controlled trial

Nicotine replacement therapy, in the form of nicotine patches, is commonly offered to pregnant women who smoke to help them to stop smoking, but this approach has limited efficacy in this population. Electronic cigarettes (e-cigarettes) are also used by pregnant women who smoke but their safety and efficacy in pregnancy are unknown. Here, we report the results of a randomized controlled trial in 1,140 participants comparing refillable e-cigarettes with nicotine patches. Pregnant women who smoked were randomized to e-cigarettes (n = 569) or nicotine patches (n = 571). In the unadjusted analysis of the primary outcome, validated prolonged quit rates at the end of pregnancy in the two study arms were not significantly different (6.8% versus 4.4% in the e-cigarette and patch arms, respectively; relative risk (RR) = 1.55, 95%CI: 0.95–2.53, P = 0.08). However, some participants in the nicotine patch group also used e-cigarettes during the study. In a pre-specified sensitivity analysis excluding abstinent participants who used non-allocated products, e-cigarettes were more effective than patches (6.8% versus 3.6%; RR = 1.93, 95%CI: 1.14–3.26, P = 0.02). Safety outcomes included adverse events and maternal and birth outcomes. The safety profile was found to be similar for both study products, however, low birthweight (<2,500 g) was less frequent in the e-cigarette arm (14.8% versus 9.6%; RR = 0.65, 95%CI: 0.47–0.90, P = 0.01). Other adverse events and birth outcomes were similar in the two study arms. E-cigarettes might help women who are pregnant to stop smoking, and their safety for use in pregnancy is similar to that of nicotine patches. ISRCTN62025374.

The effects of varenicline, bupropion, nicotine patch, and placebo on smoking cessation among smokers with major depression: A randomized clinical trial.

Improving treatment outcomes for smokers with major depressive disorder (MDD) can have significant public health implications. To evaluate the safety and efficacy of smoking cessation pharmacotherapy among smokers with MDD. Secondary analysis of a randomized, double-blind, active- (nicotine patch) and placebo-controlled trial of 12 weeks of either varenicline or bupropion with a 12-week follow-up. Community volunteers 18-75 years of age; smoke 10+ cigarettes/day; with clinically stable MDD (N = 2635) or no psychiatric disorder (N = 4028), from 140 sites in 16 countries. Twelve weeks of pharmacotherapy (placebo[PLA], nicotine replacement therapy[NRT], bupropion[BUP], varenicline[VAR]) plus brief cessation counseling. Primary safety outcome: the occurrence of ≥1 treatment-emergent, moderate to severe neuropsychiatric adverse event (NPSAE). Primary efficacy outcome: biochemically confirmed continuous abstinence(CA) during the final 4 weeks of treatment (Weeks 9-12). A total of 6653 participants (56% female; 39% MDD) ~47 years old. Risk of NPSAEs did not differ by medication for MDD. MDD had higher risk (p < .0001) for NPSAEs than the NPC. Efficacy (6653; intent-to-treat): CA rates for MDD versus NPC respectively were 31.2% versus 38.0% VAR; 23.0% versus 26.1% BUP; 22.6% versus 26.4% NRT; and 13.4% versus 13.7% PLA but no differential treatment effect was noted within the cohorts. All active treatments differed from PLA but VAR showed the largest effect. Results suggest that for MDD smokers, inclusive of those with recurrent episode, varenicline plus counseling may be the best pharmacological option for the treatment of smoking given its greater efficacy effect size and similar risk of NPSAEs. ClinicalTrials.gov Identifier: NCT01456936. https://clinicaltrials.gov/ct2/show/NCT01456936.

Rehabilitation of hemispatial neglect in stroke.

Hemi-spatial neglect (HSN) is a debilitating post stroke cognitive deficit resulting in reduced attention to stimuli presented in the contra-lateral hemi-visual field. It adversely impacts patient's medical recovery, activities of daily living and quality of life. Early referral to Rehabilitation Medicine specialist for thorough evaluation, prompt recognition of functional impairments and formulation of a comprehensive rehabilitation plan unique to patient is important. It is part of the comprehensive and holistic management of stroke patients with HSN. We summarize the current management strategies used for post-stroke HSN rehabilitation with the options including non-invasive brain stimulation, visuomotor feedback training, robotic rehabilitation and trans-dermal nicotine patch.

Prevalence of Smoking and Beliefs and Attitude Toward Smoking Habit and Smoking Cessation Methods Among Pharmacy Students: A Cross-Sectional Study in Saudi Arabia.

ObjectiveThe impact of pharmaceutical services on public health especially in regards to smoking cessation counseling can influence the rate of smoking cessation. The present study aims to evaluate prevalence, beliefs, and attitude of pharmacy students toward smoking habit and SC methods.MethodsAn online cross-sectional survey was conducted among pharmacy students at King Saud University, Riyadh, Saudi Arabia over 4-month period from May to August 2021. The survey consisted of 22-items focused on evaluating the prevalence, belief, and attitude toward smoking habits and smoking cessation methods. Data was descriptively analyzed using a statistical package for social science version 26 (SPSS).ResultsA total of 675 students completed the survey, among which 78.7 % were non-smokers and only 31.7% received education on the dangers of smoking. The most common methods of smoking cessation they heard of were consultation (58.6%), followed by use of electronic cigarettes (41.92 %) and Nicotine patch (40.7%). One-third of the surveyed students (36.8 %) agreed that specialized smoking cessation clinics enhance the efficacy of smoking cessation methods. The majority of students (80.6%) agreed to ban smoking in public places and 92.2% believed that tobacco sales to adolescents should be forbidden. Health professionals should actively participate and advise their patients to quit smoking as 89.8 % students agreed on that. Age and gender of students had significantly influenced the prevalence of smoking, history of smoking, frequency of smoking, efforts to quit smoking among smokers (p = 0.0001).ConclusionThe prevalence of non-smokers among pharmacy students is encouraging, yet level of awareness about and usefulness of smoking cessation methods is unsatisfactory. Therefore, the study clearly highlights a great need for integrating smoking cessation programs in their academic curricula to prepare them for real-world practice.

Evaluating Nicotine as a Cognitive Enhancer

Nicotine is a bicyclic chemical compound that is derived from tobacco plants. Due to its effect on the brain, nicotine is addictive and has long been used as a popular recreational drug. In numerous studies, nicotine has been shown to improve memory and reaction time performances. Some nicotine skin patch studies have exhibited characteristics of a possible treatment for cognitive impairments (Rezvani and Levin, 2001). Although many studies have shown that nicotine has cognitive-enhancing effects, there is not sufficient research conducted to examine the specific impacts of nicotine on reaction time. The aim of this study is to assess how reaction time differs before and after nicotine use for people who regularly use the drug and to test how the reaction times of non-users compares to those of regular users. This study was conducted on individuals aged 18 to 22. A Brain Gauge device and its associated software was used to collect reaction time data. Each user completed the Hardware Reaction Time test, which required the participant to press a button with their right index finger as soon as they felt the stimulus that was delivered to their right ring finger. It was found that people who did not use nicotine had faster reaction times than those who use nicotine regularly. However, regular nicotine users had slower reaction times before nicotine use as compared to after nicotine use. Although these results improve our understanding of the effects of nicotine use, there were limitations to the study. The experiment was not well-controlled as the environment of each participant was different, and the population tested consisted of mostly people in their early 20s. Further studies should be conducted with more controlled testing conditions and with a more diverse population.

Time-Varying Mediation of Pharmacological Smoking Cessation Treatments on Smoking Lapse via Craving, Cessation Fatigue, and Negative Mood.

The addictive nature of nicotine makes smoking cessation an extremely challenging process. With prolonged exposure, tobacco smoking transforms from being a positive reinforcer to a negative one, as smoking is used to mitigate aversive withdrawal symptoms. Studying the variations in withdrawal symptoms, especially during their peak in the first week of a quit attempt, could help improve cessation treatment for the future. The time-varying mediation model effectively studies whether altering withdrawal symptoms act as mediators in the pathway between treatment and cessation. This secondary data analysis of a randomized clinical smoking cessation trial of three pharmacotherapy regimens (nicotine patch, varenicline, and nicotine patch + mini-lozenge) analyzes ecological momentary assessment (EMA) data from the first 4 weeks post-target quit day (TQD). We assess whether withdrawal symptoms (eg, negative mood, cessation fatigue, and craving) mediate the pathway between pharmacotherapy and daily smoking status and whether this effect varies over time. We found a statistically significant time-varying mediation effect of varenicline on smoking status through craving, which shows decreasing risk of lapse via reduction in craving. We did not find significant time-varying mediation effects through negative mood and cessation fatigue. This study supports the importance of craving suppression in the smoking cessation process. It also helped identify specific timepoints when withdrawal symptoms increased that would likely benefit from targeted cessation intervention strategies. This study aimed to understand the underlying dynamic mechanisms of the smoking cessation process using a new analytical approach that capitalizes on the intensive longitudinal data collected via EMAs. The findings from this study further elucidate the smoking cessation process and provide insight into behavioral intervention targets and the timing of such interventions through the estimation of time-varying mediation effects.

Effect of Combination Treatment With Varenicline and Nicotine Patch on Smoking Cessation Among Smokers Who Drink Heavily

The concurrent use of both tobacco and alcohol causes substantial disease and early mortality, and smokers who drink heavily tend to be less successful in smoking cessation than smokers who do not. Although varenicline combined with nicotine replacement therapy for smoking cessation has been examined among smokers who do not drink heavily, this combination treatment has not yet been examined among smokers who drink heavily. To determine whether combined treatment with varenicline tartrate and nicotine patch improves continuous abstinence from cigarette smoking among smokers who drink heavily. This double-blind, placebo-controlled, superiority randomized clinical trial evaluated combined treatment with varenicline and nicotine patch compared with placebo and nicotine patch for smoking cessation (primary outcome) and drinking behavior (secondary outcome) among smokers who drink heavily. The clinical trial was conducted at 2 outpatient sites in Chicago, Illinois, with enrollment from March 26, 2018, to February 14, 2020. The 122 participants were recruited from the community via social media and public transit advertisements and equally randomized to the 2 treatment groups, which were stratified by sex and smoking behavior. Eligible participants smoked between 5 and 30 cigarettes per day and drank heavily (>14 drinks per week for men or >7 drinks per week for women and ≥1 heavy drinking day [defined as >5 drinks per occasion for men or >4 drinks per occasion for women] per month for the past year) and had a desire to quit smoking. Varenicline tartrate, 1.0 mg, twice daily or matching placebo pills twice daily for 12 weeks. Nicotine patch at manufacturer-recommended doses for 10 weeks and brief individual smoking cessation counseling the week before the quit date and on the quit date. The primary outcome was self-reported continuous cigarette abstinence through weeks 9 to 12; abstinence was biochemically confirmed at the week 12 study visit. Secondary outcomes were the frequency of weekly drinking and weekly heavy drinking during the study period. Among 122 participants (mean [SD] age, 44.0 [12.4] years; 67 men [54.9%]), 61 were randomly assigned to receive combined treatment with varenicline and nicotine patch (varenicline group), and 61 were randomly assigned to receive placebo and nicotine patch (placebo group). A total of 54 participants (44.3%) self-identified as Black, 56 (45.9%) as White, and 12 (9.8%) as other races (including American Indian or Alaska Native, Asian, >1 race, and unspecified race). A total of 8 participants (6.6%) self-identified as Hispanic and 114 (93.4%) as non-Hispanic ethnicity. Study retention to 12 weeks was 89%. The intention-to-treat analyses showed higher smoking cessation rates during weeks 9 to 12 in the varenicline group vs the placebo group (27 participants [44.3%] vs 17 participants [27.9%]; odds ratio, 2.20; 95% CI, 1.01-4.80; P = .047) and lower likelihood of relapse throughout treatment in the varenicline group relative to the placebo group (hazard ratio, 0.62; 95% CI, 0.40-0.96; P = .03). Both treatments were well tolerated; however, compared with participants in the placebo group, those in the varenicline group experienced more adverse effects, with 5 participants in the varenicline group discontinuing medication due to adverse effects. In this study, combined treatment with varenicline and nicotine patch was more effective than placebo and nicotine patch for smoking cessation among smokers who drink heavily. The combination treatment had no effect on alcohol consumption, with both groups showing significant reductions. Combination treatment with varenicline and nicotine patch may be a viable option for smokers who drink heavily. ClinicalTrials.gov Identifier: NCT02859142.

Nicotine and Inflammatory Disease in Humans: A Systematic Review

Summary Introduction Previous studies have shown that nicotine interacts in inflammatory pathways and may have both pro- and anti-inflammatory actions. The aim of this study was to carry out a systematic review of publications investigating the inflammatory effects of nicotine in models of human disease. Methods The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) checklists were followed during the design and implementation of this study. Searches were carried out across PubMed, Science Direct, and the Cochrane Library. Articles were included if they were published in English, in peer-reviewed journals, reported an effect of nicotine in the treatment of a clinical condition, experimental studies or clinical trials which investigated an effect of nicotine administration in patients with a clinical condition or epidemiological studies which investigated an effect of nicotine administration in patients with a clinical condition. Results Thirty-eight studies were identified and categorized into disease areas before systematic review. Nineteen studies were related to digestive diseases (primarily Crohn’s disease and ulcerative colitis), six to atherosclerosis, five to skin and healing, four to pain and infection, three to pulmonary sarcoidosis, and three to multiple sclerosis (one study reported data on three disease areas). Risk of bias assessment was not carried out, but the general quality of the studies was low, mostly offering preliminary data in small numbers of participants. No consistent effects of nicotine treatment (primarily through use of transdermal nicotine patches or nicotine chewing gums) were reported across any of the disease models. Conclusion No reliable evidence of a pro- or anti-inflammatory effect of nicotine was observed in patients with any of the diseases included in this study.

Full-scale Randomized Trial Comparing Acceptance and Commitment Therapy Telephone-Delivered Coaching With Standard Telephone-Delivered Coaching Among Medicare/Uninsured Quitline Callers.

The aim of this study was to compare Acceptance and Commitment Therapy (ACT) telephone-delivered coaching with standard quitline (QL) telephone-delivered coaching. Medicare/uninsured adults (analyzable sample N = 1170) who smoked at least 10 cigarettes per day were recruited from Optum, a major US provider of QL services, in a two-arm stratified double-blind randomized trial with main outcome of self-reported missing = smoking 30-day point prevalence abstinence (PPA) at the 12-month follow-up. Participants were mean (SD) age 47.4 (12.7), 61% female, and 72% white race. Five sessions of telephone-delivered ACT or QL interventions were offered. Both arms included combined nicotine patch (4 weeks) and gum or lozenge (2 weeks). The 12-month follow-up data retention rate was 67.8%. ACT participants reported their treatment was more useful for quitting smoking (92.0% for ACT vs. 82.3% for QL; odds ratio [OR] = 2.48; 95% confidence interval [CI]: 1.53 to 4.00). Both arms had similar 12-month cessation outcomes (missing = smoking 30-day PPA: 24.6% for ACT vs. 28.8% for QL; OR =.81; 95% CI: 0.62 to 1.05) and the ACT arm trended toward greater reductions in number cigarettes smoked per day (-5.6 for ACT vs. -1.7 QL, among smokers; p = .075). ACT telephone-delivered coaching was more satisfying, engaging, and was as effective as standard QL telephone-delivered coaching. ACT may help those who fail to quit after standard coaching or who choose not to use nicotine replacement therapy. In a sample of Medicare and uninsured QL callers, a large randomized trial with long-term follow-up showed that ACT) telephone-delivered coaching was more satisfying, engaging, and was as effective as standard QL telephone-delivered coaching-which has followed the same behavior change approach since the 1990s. This newer model of coaching might be a welcome addition to QL services.

Special Report: Be Prepared to Address Technological Addictions in Psychiatric Practice

Special Report: Be Prepared to Address Technological Addictions in Psychiatric Practice