Smoking Abstinence Rates Research Articles

E-CIGARETTE SWITCHING AND FINANCIAL INCENTIVES TO PROMOTE COMBUSTIBLE CIGARETTE CESSATION AMONG ADULTS ACCESSING SHELTER SERVICES: A PILOT STUDY

BackgroundSmoking prevalence among U.S. adults experiencing homelessness is ≥70%. Interventions are needed to address persisting tobacco disparities. MethodsAdults who smoked combustible cigarettes (CC) daily (N=60) were recruited from an urban day shelter and randomly assigned to an e-cigarette switching intervention with or without financial incentives for carbon monoxide (CO)-verified CC abstinence (EC vs. EC+FI). All participants received an e-cigarette device and nicotine pods during the first 4 weeks post-switch; and those in the EC+FI group also received escalating weekly incentives for CC abstinence during the same period. Key follow-ups were conducted at 4- and 8-weeks post-switch. ResultsParticipants were predominantly male (75%), 50% were racially/ethnically minoritized, with an average age of 48.8 years. Descriptive analyses indicated that CC smoking abstinence rates among EC and EC+FI were 3.3% vs. 13.3% at 4 weeks (8.3% overall) and 10.0% vs. 13.3% at 8 weeks (11.7% overall) in the intent-to-treat analyses (missing considered smoking). Among those who completed follow-ups (51.7% and 45.0% at 4- and 8-weeks), CC abstinence rates in EC and EC+FI were 6.3% vs. 26.7% at 4 weeks (16.1% overall) and 21.4% vs. 30.8% at 8 weeks (25.9% overall). EC+FI participants reported fewer days of smoking, more days of e-cigarette use, and greater reductions in CO at 4-week follow-up. Most participants reported a high likelihood of switching to e-cigarettes (67.7%). ConclusionE-cigarette switching with financial incentives for CC cessation is a promising approach to tobacco harm reduction among adults accessing shelter services. Refinements are needed to improve engagement.

Combining Default Choices and an Encounter Decision Aid to Improve Tobacco Cessation in Primary Care Patients: A Pragmatic, Cluster-Randomized Trial.

Primary care providers (PCPs) prescribe less often treatments for smoking cessation than for other major risk factors. We assessed the effect of training PCPs to offer smoking cessation treatments to current smokers as the default choice using an encounter decision aid (DA) on smoking cessation. Pragmatic, cluster-randomized controlled trial with PCPs in private practice in Switzerland and France. The intervention was a half-day course teaching PCPs the default choice approach using a DA. Control PCPs received a 1-h refresher training on smoking cessation aids. PCPs recruited daily smokers seen for routine care. The primary outcome was self-reported, 7-day, point prevalence smoking abstinence at 6 months. Secondary outcomes were quit attempts and use of smoking cessation aids at 3 weeks, 3 months, and 6 months, and a patient-reported measure of shared decision-making (CollaboRATE scale 1-10, higher scores = more involvement). Forty-two PCPs completed the training (76% Swiss) and recruited 287 current smokers (105 intervention group, 182 control group), with 51% women, mean age 48 (SD, 2.6), 77% who smoked <20 cigarettes/day, and 221 who responded at 6 months follow-up (77%). The intervention did not affect self-reported smoking abstinence rate at 6 months (9.5% intervention and 10.4% control groups, respectively; OR 0.88 (95%CI 0.37-2.10). It did however increase the number of quit attempts at 3 weeks (OR 2.09, 95%CI 1.04-4.20) and the use of smoking cessation aids at the 3-week and 3-month follow-ups (OR 2.57, 95%CI 1.21-5.45 and OR 2.00, 95%CI 1.11-3.60, respectively). The mean CollaboRATE score was 8.05/10 in the intervention group and 7.28/10 in the control group (p=0.02), reflecting more patient involvement in decision-making. Training PCPs to use a decision aid did not improve smoking abstinence rate, despite short-term increases in quit attempts and use of smoking cessation aids. It improved patient involvement in decision-making. ClinicalTrials.gov identifier: NCT04868474.

7625 Functional and structural neuronal changes of dulaglutide compared to placebo during smoking cessation - a randomized placebo-controlled trial

Abstract Disclosure: C.O. Sailer: None. S. Lengsfeld: None. D. Coynel: None. F. Baur: None. K. Bologna: None. T. Vukajlovic: None. N.A. Jeanloz: None. C. Bathelt: None. D. Zanchi: None. M. Christ-Crain: None. B.F. Winzeler: None. Introduction: Nicotine activates reward-related brain regions and chronic cigarette smoking can lead to functional and structural neuronal changes. Glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), known for their anti-obesity effects, have emerged as potential treatments for addictive disorders. A pilot study of exenatide vs placebo revealed increased short-term smoking abstinence rates and reduce smoking craving. We previously reported the results of a clinical trial (n=255) investigating the effect of dulaglutide vs placebo on smoking cessation. Herein, we report the functional magnetic resonance imaging (fMRI) results of a subset of participants. This substudy aimed to investigate the influence of dulaglutide on smoking craving, functional and structural neuronal changes of smokers aiming to quit smoking. Methods: This single-center, randomized, double-blind, placebo-controlled trial enrolled 71 participants with at least a moderate nicotine dependence, all committed to quitting smoking. Of these, 35 participants received 12 weeks dulaglutide 1.5mg, and 36 participants placebo, alongside varenicline treatment and behavioral counselling. An fMRI session was conducted at baseline and 12 weeks. The primary outcomes included smoking craving assessed on a visual analogue scale (VAS, range 0-7), differences in blood oxygen level dependent (BOLD) signal (whole brain and regions of interests, e.g., nucleus accumbens, amygdala, thalamus) and gray matter changes between sessions and groups when exposed to smoking and neutral video cues. Secondary outcomes assessed the above in quitters vs persistent smokers. Results: In line with the primary study findings, abstinence rates at 12 weeks were comparable in the dulaglutide (54%) and placebo (68%) groups (p=0.27). In a mixed effect model, smoking craving significantly decreased at 12 weeks vs baseline (-2.13 (95% CI -2.46, -1.80), p&amp;lt;0.001) and were lower for neutral vs smoking cues (-2.02 (-2.34, 1.70,), p&amp;lt;0.001). However, no significant inter-group difference was observed (-0.09 (-0.53, 0.33), p=0.65). Persistent smokers exhibited higher smoking craving at 12 weeks vs quitters (0.48 (0.06, 0.90), p=0.028), particularly when exposed to smoking cues (2.02 (1.70, 2.34), p&amp;lt;0.001). No significant differences were found in functional or structural analyses between interventions or smoking status. Conclusions: The smoking cessation intervention led to a significant reduction in smoking craving at 12 weeks without in-between group differences in behavioral, functional, or structural outcomes. Our findings challenge the hypothesis that GLP-1 RAs modulates smoking craving and behavior. It is plausible that a potential GLP-1 effect might have been masked by varenicline treatment and the unexpectedly high abstinence rate in the placebo group. Future studies should explore more potent GLP-1 RAs or dual agonists. Presentation: 6/1/2024

Abstract B019: A machine learning approach to predicting smoking cessation outcomes among Spanish-speaking smokers who completed a culturally targeted intervention

Abstract Introduction: Among the Hispanic/Latinx population in the US, four of five leading causes of death are attributed to smoking. Few evidence-based interventions have been developed to improve smoking cessation for this population. Our team has demonstrated the efficacy of a culturally targeted, extended self-help intervention for Spanish-speaking smokers, estimating a smoking abstinence rate of 33% at 24 months, compared to 24% for usual care. Further efforts are needed to enhance this efficacious, low-cost, scalable intervention approach. Machine learning (ML) is one approach to increase understanding of the predictors of treatment outcomes and inform strategies to improve the intervention. Toward that goal, this secondary data analysis utilized the decision tree (DT) model to predict self-reported 7-day point prevalence abstinence at 18-month follow-up for participants receiving our intervention. Method: Data from participants who reported smoking status at an 18-month follow-up (N=332 of 714 enrolled, 36% abstinent) were randomly split (80:20) into training and test datasets based on smoking status. We entered demographics, psychosocial, and smoking variables collected at baseline as predictors in the model. In addition to handling missing values and normalizing numeric features, we employed the Synthetic Minority Over-sampling Technique (SMOTE) combined with Tomek links (SMOTE-Tomek) to improve inter-class separability. Recursive Feature Elimination (RFE) using DT was implemented to identify the most relevant predictors. The cross-validation (CV) pipeline incorporated preprocessing, feature selection, handling class-imbalance, over-sampling, and model training with a DT as the interpretable classifier. Hyperparameters were tuned using stratified K-fold (K=5) CV to optimize parameters using Grid search. F1 score was selected as the primary metric as it accounts for each class performance by combining the precision and recall metrics. Finally, the performance of the classifier was evaluated in 20% of the unseen dataset. Results: The DT classifier for the CV achieved the F1 score of 0.73 [95% CI 0.66, 0.77], revealing a reasonably good performance in identifying smokers at 18-months. RFE selected familism, age, affect, and confidence as the most relevant predictors of smoking status. Individuals who had lower familism scores (&amp;lt;138), combined with higher age (&amp;gt;50), were more likely to be smokers at 18 months. Individuals who had higher familism scores (&amp;gt;138) combined with higher negative affect (&amp;gt;42) were more likely to be smokers. Conclusion: This study provides the first step toward personalized care for smoking cessation among the Hispanic/Latinx population and demonstrates the potential of DT classifier to predict cessation outcomes among individuals who received and completed a culturally and linguistically targeted smoking cessation intervention. Our future analysis will compare this model with conventional statistical modeling approaches and other ML algorithms to identify the best-performing parsimonious model. Citation Format: Ranjita Poudel, K. Ruwani M. Fernando, Matthew B. Schabath, Steven K. Sutton, Thomas H. Brandon, Issam El Naqa, Vani N. Simmons. A machine learning approach to predicting smoking cessation outcomes among Spanish-speaking smokers who completed a culturally targeted intervention [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr B019.

Pharmacist E-script transcription service initiated nicotine replacement therapy uptake in pre-admission clinic: A pilot study.

Pharmacist-led smoking cessation programs in pre-admission clinics (PAC) have shown to increase quit attempts and achieve abstinence by the day of surgery (DOS). To evaluate the feasibility of Pharmacist E-script Transcription Service (PETS) initiated nicotine replacement therapy (NRT) in PAC, including smoking cessation on DOS. A single centre, pre and post-intervention pilot study conducted at an Australian public hospital PAC. In a two-month intervention period, PAC nursing staff invited smokers (≥1 cigarette/day) to see a smoking cessation PET pharmacist. Pharmacist-initiated NRT and Quitline© referrals were offered. Cessation outcomes were compared with the preceding two-month control period. feasibility of intervention. DOS smoking abstinence rates and three-months post-surgery. PAC nurses identified 112 smokers over 4 months; 53 during pre-intervention period, and 59 during intervention period. Twenty-two intervention patients (37%) accepted seeing the pharmacist, with 16 subsequent Quitline© referrals (73%) and 11 NRT prescriptions (50%) written. The median nursing smoking status documentation time increased in the intervention period (1 min vs. 4, p < .001). The intervention did not impact pharmacist's workload. Verified abstinence increased from 8.5% (4/47) pre-intervention to 9.4% (5/53) post-intervention, p =1.00. Relapse rates in the intervention period increased (20% vs. 50%) at three-months post-surgery. A PETS-initiated NRT program in PAC is feasible and increased preoperative use of NRT and Quitline© with minimal impact on smoking cessation. SO WHAT?: This study has highlighted the importance of implementing a multidisciplinary smoking cessation program in PAC however, larger studies are needed to determine the true impact of the program on smoking cessations.

Smoking reduction using an electronic nicotine delivery system (ENDS) with nicotine delivery similar to combustible cigarettes

BackgroundElectronic nicotine delivery systems (ENDS) offer a promising approach to tobacco harm reduction, but many people use both ENDS and combustible cigarettes (“dual use”), which undermines potential risk reduction. To explore the role of ENDS nicotine delivery in promoting switching to ENDS, we conducted a study in which people who smoked cigarettes were offered an ENDS that had previously been shown to replicate the rapid nicotine pharmacokinetics of combustible cigarettes (BIDI® Stick).MethodsTwenty-five cigarette smoking adults, not seeking smoking cessation treatment, but open to using ENDS as a cigarette substitute, were provided with a 12-week supply of BIDI® Stick in tobacco or menthol flavors, during a study that included seven biweekly sessions and a 6-month follow-up. Daily diaries assessed ENDS and cigarette use, and exhaled carbon monoxide (eCO) served as an objective marker of smoke intake. Subjective ratings were collected to assess the rewarding properties of ENDS and combustible cigarettes, and indices of nicotine dependence.ResultsOver 12 weeks, ENDS use increased to an average of 15.8 occasions per day (SD = 20.2) and self-reported cigarette consumption decreased by 82% from 16.7 cigarettes/day (SD = 6.0) at baseline to 3.0 cigarettes/day (SD = 4.1) at week 12. The eCO level decreased by 27% from an average of 20.0 ppm (SD = 9.8) at baseline to 14.5 ppm (SD = 9.9) at week 12. Four of 25 participants completely switched to ENDS and were smoking abstinent during weeks 9–12. At 6 months one participant was confirmed to be abstinent. Ratings of subjective reward for the ENDS were very similar to those of participants’ usual brands of cigarettes. Dependence level was lower for the ENDS than for combustible cigarettes.ConclusionsIn this study, the ENDS effectively replicated the subjective rewarding effects of participants’ usual brands of cigarettes and led to a substantial reduction in reported cigarettes/day. Exhaled CO showed less of a decrease, possibly due to compensatory smoking behavior and/or the timing of eCO measurements that might not have reflected smoke intake throughout the day. The relatively low rate of sustained smoking abstinence at 6 months suggests that additional approaches continue to be needed for achieving higher rates of complete switching.Trial registrationClinicalTrials.gov identifier NCT05855343.

Varenicline and Nicotine Replacement Therapy for Smokers Admitted to Hospitals

Varenicline is the most effective sole pharmacotherapy for smoking cessation. If used in combination with nicotine replacement therapy (NRT), cessation rates may be further improved, but the efficacy and safety of the combination need to be evaluated. To examine whether hospitalized smokers treated with varenicline and NRT lozenges achieve higher prolonged smoking abstinence rates compared with those treated with varenicline alone. A double-blind, placebo-controlled randomized clinical trial was conducted in adult medical or surgical inpatients of 5 Australian public hospitals with a history of smoking 10 cigarettes or more per day, interested in quitting, and available for 12-month follow-up between May 1, 2019, and May 1, 2021 (final 12-month data collection in May 2022). Data analysis was performed from June 1 to August 30, 2023. A 12-week varenicline regimen was initiated during hospitalization at standard doses in all participants. Participants were randomized to additionally use NRT (2 mg) or placebo lozenges if there was an urge to smoke. Behavioral support (Quitline) was offered to all participants. The primary outcome was biochemically verified sustained abstinence at 6 months. Secondary outcomes included self-reported prolonged abstinence, 7-day point prevalence abstinence (3, 6, and 12 months), and medicine-related adverse events. A total of 320 participants (mean [SD] age, 52.5 [12.1] years; 183 [57.2%] male) were randomized. The conduct of biochemical verification was affected by COVID-19 restrictions; consequently, the biochemically verified abstinence in the intervention vs control arms (18 [11.4%] vs 16 [10.1%]; odds ratio [OR], 1.14; 95% CI, 0.56-2.33) did not support the combination therapy. The secondary outcomes in the intervention vs control arms of 7-day point prevalence abstinence at 6 months (54 [34.2%] vs 37 [23.4%]; OR, 1.71; 95% CI, 1.04-2.80), prolonged abstinence at 12 months (47 [29.9%] vs 30 [19.1%]; OR, 1.77; 95% CI, 1.05-3.00), and 7-day point prevalence abstinence at 12-months (48 [30.6%] vs 31 [19.7%]; OR, 1.79; 95% CI, 1.07-2.99) significantly improved with the combination therapy. The self-reported 6-month prolonged abstinence (61 [38.6%] vs 47 [29.7%]; OR, 1.49; 95% CI, 0.93-2.39) favored the combination therapy but was not statistically significant. Medicine-related adverse events were similar in the 2 groups (102 [74.5%] in the intervention group vs 86 [68.3%] in the control group). In this randomized clinical trial of the combination of varenicline and NRT lozenges in hospitalized adult daily smokers, the combination treatment improved self-reported abstinence compared with varenicline alone, without compromising safety, but it did not improve biochemically validated abstinence. anzctr.org.au Identifier: ACTRN12618001792213.

Financial incentive interventions for smoking cessation among Chinese smokers: study protocol for a cluster randomised controlled trial

IntroductionThere is an urgent issue to relieve the burdens caused by tobacco use through feasible and effective smoking cessation interventions, particularly in a middle-income country with less accessible smoking cessation...

In-clinic Versus Online Recruitment of Women With a History of Cervical Intraepithelial Neoplasia or Cervical Cancer to a Smoking Cessation Trial: A Post hoc Comparison of Participant Characteristics, Study Retention, and Cessation Outcomes.

Recruiting special populations to smoking cessation trials is challenging and approaches beyond in-clinic recruitment may be beneficial. This secondary analysis of data from a smoking cessation RCT for individuals with a history of cervical cancer or cervical intraepithelial neoplasia (CIN) explored differences associated with in-clinic vs. online recruitment. Participants were recruited from clinics within a university-based NCI-designated cancer center (n = 87) and online nationally via Facebook (n = 115). Baseline measures included sociodemographics, smoking history, and cancer or CIN history. Study retention and smoking abstinence were assessed 12 months post-baseline. Group differences in baseline characteristics were evaluated. Retention and abstinence were evaluated while controlling for group differences and predictors. Participants recruited online (vs. in-clinic) had higher educational attainment (p = .01) and health literacy (p = .003). They were more likely to have CIN versus cancer, to be further from the time of diagnosis, and to have completed active treatment (p values < .001). While controlling for these group differences and independent predictors, retention was higher among participants recruited online (log-likelihood χ2(1) = 11.41, p < .001). There were no recruitment differences in self-reported (p = .90) or biochemically confirmed smoking abstinence (p = .18). Compared to individuals recruited in-person, individuals recruited online were more educated, had higher health literacy, and presented with a different clinical profile (ie, more likely to have CIN vs. cancer and to have completed active treatment). There were few differences in participant characteristics between recruitment approaches, and no differences on any smoking-related variables. Online recruitment has the potential to improve enrollment of cancer survivors in smoking cessation trials. People with a history of CIN or cervical cancer recruited to a smoking cessation RCT online (vs. in-clinic) were more likely to have a diagnosis of CIN versus cancer and were more educated and health literate. Participants recruited online were more likely to be retained in the study and there were no differences in smoking abstinence rates at 12 months. Incorporating online recruitment increased the reach of tobacco treatment efforts to a larger and more diverse sample. This could reduce the burden of tobacco-related disease, improve CIN and cancer treatment outcomes, and reduce secondary malignancies and morbidity among this underserved group.

Systematic review and meta-analysis of text messaging interventions to support tobacco cessation

ObjectiveTo review randomised controlled trials (RCTs) investigating the effectiveness of text message-based interventions for smoking cessation, including the effects of dose (number of text messages) and concomitant use of behavioural...

Anxiety sensitivity reduction-smoking cessation intervention among individuals who engage in dual cigarette and cannabis use: A secondary analysis

IntroductionCannabis use among individuals who smoke is prevalent in the general population and related to adverse health effects, including higher levels of interoceptive perturbation (i.e., a disturbance in internal experiences). An important aspect of smoking cessation among individuals who co-use cannabis is to address behavioral associations between physiological sensations and habitual behaviors via integrated treatments focused on reducing reactivity to internal perturbations such as anxiety sensitivity (i.e., the belief that such symptoms produce personal harm). MethodsThe current study involved a secondary analysis of a randomized clinical trial (RCT) of an integrated anxiety sensitivity-smoking cessation intervention compared to standard smoking cessation. The current study sought to extend findings from the initial trial to examine if the integrated intervention produced better smoking cessation outcomes than standard care among individuals who engage in dual cigarette and cannabis use. Participants were 149 adults who engage in dual cigarette and cannabis use (41.6 % female; Mage = 30.89, SD = 13.1). ResultsResults indicated that the anxiety sensitivity intervention produced statistically significant differences in distal (long-term) smoking abstinence at 3-, 6-, and 12-month follow-up assessments but not proximal (short-term; quit-week to 2-weeks) smoking abstinence. ConclusionsOverall, the potential of an integrated anxiety sensitivity smoking cessation intervention to yield better long-term smoking abstinence rates than standard cessation treatment among individuals who engage in dual cigarette and cannabis use is clinically significant.

Effects of a text messaging smoking cessation intervention amongst online help-seekers and primary health care visitors: findings from a randomised controlled trial

BackgroundSmoking continues to be a leading risk factor for several diseases globally. We hypothesised that an intervention delivered via text messages could help individuals who were looking to quit.MethodsA two-arm, parallel-groups, randomised controlled trial was employed. Both groups received treatment as usual, with the intervention group also receiving a 12-week text messaging intervention. Participants were adult, weekly or more frequent smokers, recruited online and in primary health care centres. Research personnel were blinded, while participants were not. Primary outcomes were prolonged abstinence and point prevalence of abstinence, 3 and 6 months post-randomisation. All randomised participants were included in analyses.ResultsBetween 18 September 2020 and 16 June 2022, we randomised 1012 participants (intervention: 505, control: 507). Outcome data was available for 67% (n = 682) of participants at 3 months and 64% (n = 643) at 6 months. At 3 months, the odds ratio (OR) of prolonged abstinence was 2.15 (95% compatibility interval [CoI] = 1.51; 3.06, probability of effect [POE] > 99.9%, p < 0.0001), and for point prevalence of abstinence, it was 1.70 (95% CoI = 1.18; 2.44, POE = 99.8%, p = 0.0034) in favour of the text messaging intervention. At 6 months, the OR of prolonged abstinence was 2.38 (95% CoI = 1.62; 3.57, POE > 99.9%, p = < 0.0001), and for point prevalence, it was 1.49 (95% CoI = 1.03; 2.14, POE = 98.3%, p = 0.0349) in favour of the text messaging intervention. Analyses with imputed data were not markedly different.ConclusionsAmongst general population help-seekers—who on average had smoked for 25 years—access to a 12-week text messaging intervention produced higher rates of self-reported smoking abstinence in comparison to treatment as usual only. The intervention could be part of the societal response to the burden which smoking causes; however, findings are limited by risk of bias due to attrition, self-reported outcomes, and lack of blinding.Trial registrationThe trial was preregistered in the ISRCTN registry on 27/07/2020 (ISRCTN13455271).

Cigarette Smoking Abstinence Among Pregnant Individuals Using E-Cigarettes or Nicotine Replacement Therapy

Smoking cigarettes during pregnancy can impair maternal and child health, and pregnant individuals have increasingly used electronic cigarettes (e-cigarettes) for various reasons, including quitting smoking. To assess smoking abstinence rates among pregnant individuals who used e-cigarettes compared with those who used nicotine replacement therapy (NRT). This cohort study is a secondary data analysis of phase 8 of the US Pregnancy Risk Assessment Monitoring System, conducted between 2016 and 2020. Eligible participants included pregnant individuals who smoked combustible cigarettes within the 3 months before pregnancy and either used e-cigarettes or NRT during pregnancy. Data analysis was conducted from March 2022 to April 2023. Combustible cigarette use within 3 months before pregnancy and use of either e-cigarettes or NRT during pregnancy. The primary outcome was the individual's self-reported smoking abstinence status during the last 3 months of pregnancy. Weighted percentages were reported and weighted multivariable logistic regression models were used to examine the association of e-cigarette use vs NRT with smoking abstinence. A propensity score was used to control for confounding by sociodemographics, pregnancy characteristics, prepregnancy smoking intensity, depression, behavioral support, and hookah use. The cohort included 1329 pregnant individuals (759 ≥25 years [60.2%]; 766 non-Hispanic White individuals [79.8%]) of whom 781 had an education level of high school or lower (61.4%), and 952 had an annual household income of $48 000 or less (81.5%). Of the 1329 individuals, 890 (unweighted percentage, 67.0%) were existing e-cigarette users, 67 (unweighted percentage, 5.0%) were new e-cigarette users, and 372 (unweighted percentage, 28.0%) were NRT users. Compared with individuals who used NRT during pregnancy, individuals who used e-cigarettes had a higher rate of smoking abstinence in late pregnancy (456 individuals [50.8%] vs 67 individuals [19.4%]; propensity score adjusted odds ratio [OR], 2.47; 95% CI, 1.17-5.20; P = .02). In the secondary analysis stratified by the timing of e-cigarette use initiation, existing users of e-cigarettes who initiated before pregnancy had a higher smoking abstinence rate than NRT users (446 users [53.1%] vs 67 users [19.4%]; adjusted OR, 2.61; 95% CI, 1.23-5.51; P = .01). However, new e-cigarette users who initiated use during pregnancy had a similar smoking abstinence rate in late pregnancy when compared with NRT users (10 users [20.6%] vs 67 users [19.4%]; adjusted OR, 1.13; 95% CI, 0.22-5.87; P = .88). These findings suggest that individuals who used e-cigarettes during pregnancy had a higher smoking abstinence rate in late pregnancy than individuals who used NRT, especially for those who initiated e-cigarette use before pregnancy, indicating that replacement of cigarettes with e-cigarettes during pregnancy may be a viable strategy for harm reduction.

Access to effective smoking cessation medications in patients with medicare, medicaid and private insurance

ObjectivesCompare financial barriers to the most effective smoking cessation medications - varenicline and combination nicotine replacement therapy (CNRT) across major insurance categories and determine whether these financial barriers impact smoking cessation outcomes. Study designLongitudinal retrospective observational cohort study. MethodsPatients seen at Duke Smoking Cessation Program 05/2016 through 07/2021 were studied. Those prescribed varenicline or CNRT were determined to have financial barriers to access if they could not purchase the medication using insurance or their own funds. Outcomes were compared between Medicare, Medicaid, and private insurers. Abstinence was defined as self-reported 7-day smoking abstinence. ResultsPatients with Medicare were 5.08 times more likely to face a financial barrier to highly effective smoking cessation medications compared to patients with private insurance (p<0.00001) and 2.81 times more likely compared to Medicaid (p<0.00001). Patients able to access these highly effective medications achieved a smoking abstinence rate that was 1.58 times higher than those who could not (p = 0.01) ConclusionsFindings suggest Medicare coverage of the most effective smoking cessation medications is considerably worse than Medicaid or private insurance; inability to access these medications may lead to lower rates of smoking abstinence.

Adaptive Smoking Cessation Using Precessation Varenicline or Nicotine Patch

Adaptive pharmacotherapy, ie, starting a medication regimen and then modifying that regimen based on patient response, is common in many medical domains but is not common in smoking cessation. Recently, studies have found that adaptive treatment using precessation nicotine patches is efficacious for smoking cessation; however, adaptive treatment using precessation varenicline and adaptive treatment in clinical practice settings have not been fully assessed. To determine whether adaptive pharmacotherapy leads to higher smoking abstinence rates than standard pharmacotherapy in a clinical practice setting. This double-blinded stratified placebo-controlled randomized clinical trial compared adaptive treatment with standard treatment for smoking cessation. The study was conducted at a university health system in Durham, North Carolina, from February 2018 to May 2020 and was stopped early due to COVID-19. Data were analyzed as intent-to-treat from May 24, 2021, to February 27, 2022. Participants were allowed to choose varenicline or nicotine patches and were then randomized to adaptive or nonadaptive (standard) treatment. Participants started on their chosen medication (adaptive) or placebo (standard) 4 weeks before their target quit day. Two weeks later, participants were assessed for treatment response. Adaptive participants who did not decrease daily cigarettes smoked by at least 50% (nonresponders) received bupropion in addition to their chosen medication. Participants in the adaptative treatment group who did decrease daily cigarettes smoked by at least 50% (responders) and participants in the standard treatment group received additional placebo bupropion. Participants in the standard treatment group received varenicline starting 1 week before the target quit date or nicotine patches starting on the target quit day. All participants received brief behavioral support. The main outcome was biochemically verified 30-day continuous smoking abstinence 12 weeks after their target quit smoking day. Other measures included demographic characteristics, smoking history, and repeated smoking assessments. Of the planned 300 participants, a total of 188 participants (mean [SD] age, 49.1 [12.5] years; 102 [54%] female) were enrolled before the trial was stopped because of the COVID-19 pandemic. A total of 127 participants chose to use varenicline, including 64 randomized to adaptive treatment and 63 randomized to standard treatment, and 61 participants chose to use nicotine patches, including 31 randomized to adaptive treatment and 30 randomized to standard treatment. At baseline, participants smoked a mean (SD) of 15.4 (7.3) cigarettes per day. At 12 weeks after the target quit day, biochemically verified 30-day continuous smoking abstinence was observed in 23 of 95 participants (24%) in the adaptive treatment group and 8 of 93 participants (9%) in the standard treatment (odds ratio [OR], 3.38; 95% CI, 1.43-7.99; P = .004); among participants who used varenicline, 30-day continuous abstinence was 18 participants (28%) in the adaptive treatment group, and 5 participants (8%) in the standard treatment group (OR, 4.54; 95% CI, 1.57-13.15); among participants who used nicotine patches, 30-day continuous abstinence was 5 participants (16%) in the adaptive treatment group and 3 participants (10%) in the standard treatment group (OR, 1.73; 95% CI, 0.38-7.99). Sleep problems were more common for participants in the varenicline adaptive treatment group than in the varenicline standard treatment group (rate ratio, 1.74; 95% CI, 1.18-2.58; P = .03). This randomized clinical trial found that adaptive pharmacotherapy was efficacious for smoking cessation treatment in a practice setting. ClinicalTrials.gov Identifier: NCT02501265.

Effectiveness of intensive stand-alone smoking cessation interventions for individuals with diabetes: A systematic review and intervention component analysis.

Tobacco smoking poses a significant threat to the health of individuals living with diabetes. Intensive stand-alone smoking cessation interventions, such as multiple or long (>20 minutes) behavioral support sessions focused solely on smoking cessation, with or without the use of pharmacotherapy, increase abstinence when compared to brief advice or usual care in the general population. However, there is limited evidence so far for recommending the use of such interventions amongst individuals with diabetes. This study aimed to assess the effectiveness of intensive stand-alone smoking cessation interventions for individuals living with diabetes and to identify their critical features. A systematic review design with the addition of a pragmatic intervention component analysis using narrative methods was adopted. The key terms 'diabetes mellitus' and 'smoking cessation' and their synonyms were searched in 15 databases in May 2022. Randomized controlled trials which assessed the effectiveness of intensive stand-alone smoking cessation interventions by comparing them to controls, specifically amongst individuals with diabetes, were included. A total of 15 articles met the inclusion criteria. Generally, the identified studies reported on the delivery of a multi-component behavioral support smoking cessation intervention for individuals with type I and type II diabetes, providing biochemically verified smoking abstinence rates at follow-up at six months. The overall risk-of-bias of most studies was judged to be of some concern. Despite observing inconsistent findings across the identified studies, interventions consisting of three to four sessions, lasting more than 20 min each, were found to be more likely to be associated with smoking cessation success. The additional use of visual aids depicting diabetes-related complications may also be useful. This review provides evidence-based smoking cessation recommendations for use by individuals with diabetes. Nonetheless, given that the findings of some studies were found to be possibly at risk-of-bias, further research to establish the validity of the provided recommendations is suggested.

Efficacy and safety of selegiline across different psychiatric disorders: A systematic review and meta-analysis of oral and transdermal formulations

Selegiline is an irreversible, selective type-B monoamine oxidase inhibitor (MAOI) approved for Parkison's disease—oral and major depressive disorder—transdermal formulation) resulting in non-selective MAOI activity at oral doses≥20 mg/day. The present systematic review and meta-analysis appraises the evidence of different formulations/dosages of selegiline across different psychiatric conditions. We inquired PubMed/MEDLINE/Cochrane-Central/WHO-ICTRP/Clarivate-WebOfScience and the Chinese-Electronic-Journal Database from inception to 10/26/2022 for selegiline trials involving psychiatric patients. Random-effects meta-analyses assessed heterogeneity, publication/risk biases, and confidence in the evidence, followed by sensitivity, subgroup, and meta-regression analyses. Co-primary outcomes were: changes in symptom score (standardized mean difference=SMD) and author-defined response (risk ratios=RRs). RRs of adverse events and all-cause discontinuation were secondary and acceptability outcomes, respectively. Systematic-review included 42 studies; meta-analysis, 23. Selegiline outperformed placebo in depressive symptom reduction (SMD=-0.96, 95%C.I.=-1.78, -0.14, k = 10, n = 1,308), depression (RR=1.61, 95%C.I.=1.20, 2.15, k = 9, n = 1,238) and atypical-depression response (RR=2.23, 95%C.I.=1.35, 3.68, k = 3, n = 136). Selegiline failed to outperform the placebo in negative (k = 4) or positive symptoms of schizophrenia (k = 4), attention-deficit-hyperactivity disorder (ADHD) symptoms reduction (k = 2), and smoking abstinence rate (k = 4). Selegiline did not differ from methylphenidate and ADHD scores (k = 2). No significant difference emerged in acceptability, incident diarrhea, headache, dizziness, and nausea RRs, in contrast to xerostomia (RR=1.58, 95%C.I. =1.03, 2.43, k = 6, n = 1,134), insomnia (RR=1.61, 95%C.I.=1.19, 2.17, k = 10, n = 1,768), and application-site reaction for transdermal formulation (RR=1.81, 95%C.I.=1.40, 2.33, k = 6, n = 1,662). Confidence in findings was low/very-low for most outcomes; moderate for depressive symptoms reduction (transdermal). Selegiline proved effective, safe, and well-tolerated for depressive disorders, yet further evidence is warranted about specific psychiatric disorders.

The Effectiveness of Smartphone App-Based Interventions for Assisting Smoking Cessation: Systematic Review and Meta-analysis.

Smoking is a leading cause of premature death globally. Quitting smoking reduces the risk of all-cause mortality by 11%-34%. Smartphone app-based smoking cessation (SASC) interventions have been developed and are widely used. However, the evidence for the effectiveness of smartphone-based interventions for smoking cessation is currently equivocal. The purpose of this study was to synthesize the evidence for the effectiveness of smartphone app-based interventions for smoking cessation. We conducted a systematic review and meta-analysis of the effectiveness of smartphone interventions for smoking cessation based on the Cochrane methodology. An electronic literature search was performed using the Cochrane Library, Web of Science, PubMed, Embase, PsycINFO, China National Knowledge Infrastructure, and Wanfang databases to identify published papers in English or Chinese (there was no time limit regarding the publication date). The outcome was the smoking abstinence rate, which was either a 7-day point prevalence abstinence rate or a continuous abstinence rate. A total of 9 randomized controlled trials involving 12,967 adults were selected for the final analysis. The selected studies from 6 countries (the United States, Spain, France, Switzerland, Canada, and Japan) were included in the meta-analysis between 2018 and 2022. Pooled effect sizes (across all follow-up time points) revealed no difference between the smartphone app group and the comparators (standard care, SMS text messaging intervention, web-based intervention, smoking cessation counseling, or apps as placebos without real function; odds ratio [OR] 1.25, 95% CI 0.99-1.56, P=.06, I2=73.6%). Based on the subanalyses, 6 trials comparing smartphone app interventions to comparator interventions reported no significant differences in effectiveness (OR 1.03, 95% CI 0.85-1.26, P=.74, I2=57.1%). However, the 3 trials that evaluated the combination of smartphone interventions combined with pharmacotherapy compared to pharmacotherapy alone found higher smoking abstinence rates in the combined intervention (OR 1.79, 95% CI 1.38-2.33, P=.74, I2=7.4%). All SASC interventions with higher levels of adherence were significantly more effective (OR 1.48, 95% CI 1.20-1.84, P<.001, I2=24.5%). This systematic review and meta-analysis did not support the effectiveness of delivering smartphone-based interventions alone to achieve higher smoking abstinence rates. However, the efficacy of smartphone-based interventions increased when combined with pharmacotherapy-based smoking cessation approaches. PROSPERO CRD42021267615; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=267615.

Coordinating smoking cessation treatment with menstrual cycle phase to improve quit outcomes (MC-NRT): study protocol for a randomized controlled trial

BackgroundWomen experience greater difficulty achieving smoking abstinence compared to men. Recent evidence suggests that hormonal fluctuations during different phases of the menstrual cycle can contribute to lower smoking abstinence rates following a quit attempt among women. However, these findings are limited by small sample sizes and variability among targeted smoking quit dates. This clinical trial aims to clarify whether targeting the quit date to the follicular or luteal phase of the menstrual cycle can improve smoking abstinence.MethodsParticipants will enroll in an online smoking cessation program providing nicotine replacement therapy (NRT) and behavioral support. We will randomize 1200 eligible individuals to set a target quit date: (1) during the mid-luteal phase, (2) during the mid-follicular phase, or (3) 15–30 days after enrollment with no regard to the menstrual cycle phase (usual practice). Participants will receive a 6-week supply of combination NRT consisting of a nicotine patch plus their choice of nicotine gum or lozenge. Participants will be instructed to start using NRT on their target quit date. Optional behavioral support will consist of a free downloadable app and brief videos focusing on building a quit plan, coping with cravings, and relapse prevention, delivered via e-mail. Smoking status will be assessed via dried blood spot analysis of cotinine concentration at 7 days, 6 weeks, and 6 months post-target quit date.DiscussionWe aim to overcome the limitations of previous studies by recruiting a large sample of participants and assigning target quit dates to the middle of both the follicular and luteal phases. The results of the trial can further elucidate the effects of the menstrual cycle on smoking cessation outcomes and whether it is beneficial to combine menstrual cycle phase timing strategies with accessible and low-cost NRT.Trial registrationClinicalTrials.gov NCT05515354. Registered on August 23, 2022.

Safety and efficacy of early varenicline prescription in hospitalized patients with acute myocardial infarction: East Asian population

Smoking is a strong risk factor for patients with acute myocardial infarction (AMI). Varenicline is commonly used as a smoking cessation medication, but little is known about its usage in patients with AMI, particularly in hospitalized patients. This is a prospective observational, single-center study collected from May 2018 to July 2021. Study patients underwent percutaneous coronary intervention for AMI.The primary end point was set as safety of varenicline, focusing on any serious adverse cardiac events within 24 weeks after treatment. Efficacy of smoking abstinence was also assessed through self-reports of complete abstinence over a week before the 24- week clinic visit. A total of 162 patients hospitalized with AMI were enrolled in our study. Mean age was 56.7 ± 9.95 years and 97% of the patients were male. Most patients (93.2%) received their first dose of varenicline during hospitalization. Time from admission to first dose of study medication was 2.31 ± 2.73 days and duration of drug intake was 7.41 ± 5.18 weeks. At week 24, only one patient had recurrent myocardial infarction, five patients had undergone revascularization for target lesion failure, and no additional patients developed stroke or died. In terms of efficacy, the rate of smoking abstinence was 79%. Light smokers found it easier to quit smoking than heavy smokers. This study may represent the first report on the safety and efficacy of early initiation of varenicline treatment in East Asian population hospitalized due to AMI who recently underwent percutaneous coronary intervention.