Varenicline and counseling for vaping cessation: a double-blind, randomized, parallel-group, placebo-controlled trial.

BACKGROUND: Vaping cessation is virtually unexplored. The efficacy and safety of varenicline for vaping cessation has not been studied and rigorous research is required to advance best practice and outcomes for people who use electronic cigarettes (EC) and want to quit. The objective is to evaluate the efficacy and safety of varenicline (1 mg BID, administered for 12 weeks, with follow-up to week 24) combined with vaping cessation counseling in exclusive daily EC users intending to quit vaping. METHODS: Design: Double-blind, randomized, parallel-group, placebo-controlled trial. SETTING: The study took place at a University-run smoking cessation center. PARTICIPANTS: People who exclusively use ECs daily and intend to quit vaping. INTERVENTION: A total of 140 subjects were randomized to either varenicline (1 mg, administered twice daily for 12 weeks) plus counseling or placebo treatment (administered twice daily, for 12 weeks) plus counseling. The trial consisted of a 12-week treatment phase followed by a 12-week follow-up, nontreatment phase. MAIN OUTCOMES AND MEASURES: The primary efficacy endpoint of the study was biochemically validated continuous abstinence rate (CAR) at weeks 4 to 12. Secondary efficacy end points were CAR at weeks 4 to 24 and 7-day point prevalence of vaping abstinence at weeks 12 and 24. RESULTS: CAR was significantly higher for varenicline vs placebo at each interval: weeks 4-12, 40.0% and 20.0%, respectively (OR = 2.67, 95% CI = [1.25-5.68], P = 0.011); weeks 4-24, 34.3% for varenicline with counseling and 17.2% for placebo with counseling (OR = 2.52, 95% CI = [1.14-5.58], P = 0.0224). The 7-day point prevalence of vaping abstinence was also higher for the varenicline than placebo at each time point. Serious adverse events were infrequent in both groups and not treatment-related. CONCLUSIONS: The findings of the present RCT indicate that inclusion of varenicline in a vaping cessation program for people who use electronic cigarettes and intending to quit may result in prolonged abstinence. These positive findings establish a benchmark of intervention effectiveness, may support the use of varenicline combined with counseling in vaping cessation programs, and may also help guiding future recommendations by health authorities and healthcare providers. TRIAL REGISTRATION: The study has been registered in EUDRACT with Trial registration ID: 2016-000339-42.

Transcranial Magnetic Stimulation for the Treatment of Gambling Disorder: A Systematic Review.

BACKGROUND: Gambling Disorder (GD) is a behavioral addiction listed within the diagnostic category of substance-related and addictive disorders. Recently, transcranial magnetic stimulation (TMS), which non-invasively stimulates the brain and has neuromodulatory properties, has emerged as an innovative treatment tool for GD, thus offering a new option for the management of this complex disorder. The present review explored the efficacy of TMS as a possible non-pharmacological treatment for GD. METHODS: An exhaustive search was performed across the MEDLINE, Web of Science, and EMBASE databases using a specific search string related to GD and TMS. A total of 20 papers were selected for full-text examination, out of which eight fulfilled the inclusion criteria and were therefore systematically analyzed in the present review. RESULTS: This review included eight studies: three randomized-controlled trials (RCTs), three non-controlled studies, one case series, and one case report. Two cross-over RCTs described a decrease in craving after high-frequency (excitatory), repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC) and the medial prefrontal cortex (PFC), respectively; another study applying low-frequency (inhibitory) rTMS on the right DLPFC did not find any positive effect on craving. Among uncontrolled studies, one demonstrated the beneficial effect of high-frequency rTMS over the left DLPFC, while another showed the efficacy of a continuous theta burst stimulation protocol directed over the pre-supplementary motor area, bilaterally. CONCLUSION: The included studies showed the promising effect of excitatory stimulation over the left PFC. However, further investigation is needed, particularly in terms of standardizing stimulation protocols and psychometric assessments.

A Single-Arm, Open-Label, Pilot, and Feasibility Study of a High Nicotine Strength E-Cigarette Intervention for Smoking Cessation or Reduction for People With Schizophrenia Spectrum Disorders Who Smoke Cigarettes.

INTRODUCTION: An estimated 60%-90% of people with schizophrenia smoke, compared with 15%-24% of the general population, exacerbating the already high morbidity and mortality rates observed in this population. AIMS AND METHODS: This study aimed to assess the feasibility of using a new-generation high strength nicotine e-cigarette to modify smoking behavior in individuals with schizophrenia spectrum disorders who smoke cigarettes. A single-arm pilot study was conducted with 40 adults with schizophrenia spectrum disorders who smoked and did not intend to reduce or quit smoking. Participants were given a 12-week supply of a JUUL e-cigarette loaded with a 5% nicotine pod. The primary outcome was smoking cessation at week 12. Additional outcomes included: smoking reduction, continuous abstinence at week 24, adoption rate, adherence to the e-cigarette, feasibility, acceptability, and subjective effects. RESULTS: Sixteen (40%) participants quit by the end of 12 weeks. For the whole sample, we observed an overall, sustained 50% reduction in smoking or smoking abstinence in 37/40 (92.5%) of participants and an overall 75% reduction in median cigarettes per day from 25 to six was observed by the end of the 12 weeks (p < .001). CONCLUSIONS: A high strength nicotine e-cigarette has the potential to help people with schizophrenia spectrum disorders to quit or reduce smoking. Further research with a larger sample and a comparator group is needed. The results provide useful information and direction to augment the existing body of knowledge on smoking cessation for people with schizophrenia spectrum disorders. IMPLICATIONS: Considering that most people with schizophrenia spectrum disorders continue smoking, alternative and efficient interventions to reduce or prevent morbidity and mortality are urgently needed. This study showed that adults who smoke and were not motivated to quit, when provided a new-generation e-cigarette with high nicotine content, demonstrated substantially decreased cigarette consumption without causing significant side effects. Although not specifically measured in this study, nicotine absorption in new-generation devices has been shown to be consistently superior compared with the first generation of e-cigarette devices, and this may help explain the lower quit rates in studies using earlier generation devices.

Lifetime prevalence of suicidal ideation and suicidal behaviors in gender non-conforming youths: a meta-analysis.

Gender identity represents a topic of growing interest in mental health research. People with non-conforming gender identity are prone to suffer from stigmatization and bullying and often present psychiatric issues, which may in turn lead to a high prevalence of suicidal ideation and behaviors. The present meta-analysis aimed to estimate the prevalence of suicidal ideation and suicidal behaviors in gender non-conforming children, adolescents and young adults. A systematic search was performed in Web of Science and PsycINFO from inception to December 2018. We selected cross-sectional and cohort studies including youths (up to 25 years) with a diagnosis confirmed by a clinician according to international classifications, or after a direct interview with a peer. A random-effects meta-analysis was computed for the following outcomes: non-suicidal self-injury (NSSI), suicidal ideation and suicide attempts. Overall, we found a mean prevalence of NSSI of 28.2% (9 studies, 3057 participants, 95% CI 14.8-47.1). A similar prevalence (28%) was found for suicidal ideation (6 studies, 2249 participants, 95% CI 15-46.3), while the prevalence of suicide attempts was 14.8% (5 studies, 1039 participants, 95% CI 7.8-26.3). Subgroup analyses revealed no significant differences according to biological sex. Given the prevalence of suicidal behaviors in gender non-conforming youths, it appears desirable to implement therapeutic and support strategies for this population. Moreover, educational interventions directed to parents, teachers, mental health professionals and general community should be promoted to struggle against stigma and social isolation, factors that may contribute to increasing the risk of suicidal behaviors.

Carbon monoxide levels after inhalation from new generation heated tobacco products.

Heated tobacco products (HTPs) are new tech devices that release nicotine and other volatile compounds into an inhalable aerosol by heating the tobacco. At their operating temperatures, tobacco combustion is unlikely.The aim of this randomized cross-over study was to measure the exposure levels of the combustion marker, carbon monoxide in the exhaled breath (eCO) of subjects after use of two HTPs and to compare these levels with participants' own brand of cigarettes.A total of 12 healthy smokers who reported smoking ≥10 conventional cigarettes per day for at least 5 years took part in the study. Product administration consisted of a first round of 10 puffs, which was followed by an identical second round after a 5 min pause in between rounds. After obtaining a baseline eCO value, this measure was recorded at 5, 10, 15, 30, and 45 min after the first puff of the first round. In contrast to combustible cigarettes, no eCO elevations were observed in the exhaled breath after use of the HTPs under investigation in any of the study participants.

Changes in breathomics from a 1-year randomized smoking cessation trial of electronic cigarettes.

BACKGROUND: Electronic cigarette (EC) use is an emerging behaviour that has been shown to help smokers to reduce cigarette consumption. The aim of this study was to illustrate long-term changes in exhaled breath measurements and respiratory symptoms in smokers invited to quit or reduce their cigarette consumption by switching to ECs. MATERIALS AND METHODS: Prospective evaluation of cigarette consumption, fractional nitric oxide concentration in exhaled breath (FeNO), exhaled carbon monoxide (eCO) and symptom scores was performed in a 1-year randomized, controlled trial of 'healthy' smokers receiving 2·4% nicotine, 1·8% nicotine or no nicotine ECs. FeNO and eCO data are presented on the basis of participants' pooled continuous smoking phenotype classification (failures, reducers and quitters). RESULTS: A significant effect of quitting classification was found on FeNo and eCO at all time points (P < 0·0001). Among quitters, FeNO (medians and interquartile range) rose from 5·5 (4·5-6·9) ppb to 17·7 (13·3-18·9) ppb by week 52. Baseline eCO (medians and interquartile range) decreased from 17 (12-20) ppm to 3 (1-4) ppm by week 52. No significant changes in FeNO and eCO levels were observed in failures and reducers. Improvements in FeNO and eCO levels were correlated with attenuations in symptom scores. CONCLUSIONS: Smokers invited to switch to electronic cigarettes who completely abstained from smoking showed steady progressive improvements in their exhaled breath measurements and symptom scores. FeNo and eCO normalization is highly supportive of improved respiratory health outcomes and adds to the notion that quitting from tobacco smoking can reverse harm in the lung.

Evidence for harm reduction in COPD smokers who switch to electronic cigarettes.

BACKGROUND: Electronic cigarettes (ECs) are battery-operated devices designed to vaporise nicotine, which may help smokers quitting or reducing their tobacco consumption. There is a lack of data on the health effects of EC use among smokers with COPD and whether regular use results in improvement in subjective and objective COPD outcomes. We investigated long-term changes in objective and subjective respiratory outcomes in smokers with a diagnosis of COPD who quit or reduced substantially their tobacco consumption by supplementing with or converting only to ECs use. METHODS: We conducted a retrospective chart review of patients with COPD to identify those reporting regular daily use of ECs on at least two follow-up visits at 12- (F/up1) and 24-months (F/up2). Regularly smoking COPD patients were included as a reference group. RESULTS: A marked reduction in cigarette consumption was observed in ECs users. A significant reduction in COPD exacerbations was reported in the COPD EC user group, their mean (±SD) decreasing from 2.3 (±1) at baseline to 1.8 (±1; p = 0.002) and 1.4 (±0.9; p < 0.001) at F/up1 and F/up2 respectively. A significant reduction in COPD exacerbations was also observed in ECs users who also smoked conventional cigarettes (i.e. 'dual users'). COPD symptoms and ability to perform physical activities improved statistically in the EC group at both visits, with no change in the control group. CONCLUSIONS: These findings suggest that ECs use may aid smokers with COPD reduce their cigarette consumption or remain abstinent, which results in marked improvements in annual exacerbation rate as well as subjective and objective COPD outcomes.

Lung function and respiratory symptoms in a randomized smoking cessation trial of electronic cigarettes.

Quitting smoking is the most important step smokers can take to improve their health. Nonetheless, there is little information on long-term improvements in lung function and/or respiratory symptoms after smoking cessation. Here we illustrate long-term changes in spirometric indices as well as in respiratory symptoms in smokers invited to quit or reduce their cigarette consumption by switching to electronic cigarettes (ECs). Prospective evaluation of cigarette consumption, spirometry and symptoms was performed in a 1-year randomized controlled trial of smokers receiving EC containing 2.4%, 1.8% or 0% nicotine. Spirometric data are presented on the basis of participants' pooled continuous smoking phenotype classification (Quitters, Reducers, Failures), whereas respiratory symptoms on the basis of their point prevalence-smoking phenotype. Smoking phenotype classification (Quitters, Reducers, Failures) had no significant effect on spirometric indices (FEV1, FVC and FEV1/FVC) with the exception of FEF25-75%, which significantly (P =0.034) increased over the time among Quitters; their FEF25-75% (% predicted) improving from (means±S.D.) 85.7±15.6% at baseline (BL) to 100.8±14.6%. High prevalence of cough/phlegm (43.1%) and shortness of breath (SoB; 34.8%) was reported at BL with substantial reduction in their frequency at subsequent follow-up visits. These symptoms virtually disappeared very quickly in both quitters and reducers. Smokers invited to switch to ECs who completely abstained from smoking showed steady progressive improvements in their FEF25-75% Normalization of peripheral airways function was associated with improvement in respiratory symptoms, adding to the notion that abstaining from smoking can reverse tobacco harm in the lung.

Success rates with nicotine personal vaporizers: a prospective 6-month pilot study of smokers not intending to quit.

BACKGROUND: Electronic cigarettes (e-Cigs) are an attractive long-term alternative nicotine source to conventional cigarettes. Although they may assist smokers to remain abstinent during their quit attempt, studies using first generation e-Cigs report low success rates. Second generation devices (personal vaporisers - PVs) may result in much higher quit rates, but their efficacy and safety in smoking cessation and/or reduction in clinical trials is unreported. METHOD: We conducted a prospective proof-of-concept study monitoring modifications in smoking behaviour of 50 smokers (unwilling to quit) switched onto PVs. Participants attended five study visits: baseline, week-4, week-8, week-12 and week-24. Number of cigarettes/day (cigs/day) and exhaled carbon monoxide (eCO) levels were noted at each visit. Smoking reduction/abstinence rates, product usage, adverse events and subjective opinions of these products were also reviewed. RESULTS: Sustained 50% and 80% reduction in cigs/day at week-24 was reported in 15/50 (30%) and 7/50 (14%) participants with a reduction from 25cigs/day to 6cigs/day (p < 0.001) and 3cigs/day (p < 0.001), respectively. Smoking abstinence (self-reported abstinence from cigarette smoking verified by an eCO ≤10 ppm) at week-24 was observed in 18/50 (36%) participants, with 15/18 (83.3%) still using their PVs at the end of the study. Combined 50% reduction and smoking abstinence was shown in 33/50 (66%) participants. Throat/mouth irritation (35.6%), dry throat/mouth (28.9%), headache (26.7%) and dry cough (22.2%) were frequently reported early in the study, but waned substantially by week-24. Participants' perception and acceptance of the products was very good. CONCLUSION: The use of second generation PVs substantially decreased cigarette consumption without causing significant adverse effects in smokers not intending to quit. TRIAL REGISTRATION: (ClinicalTrials.gov Identifier: NCT02124200).

[Electronic cigarette: current overview and future perspectives]. / Sigaretta elettronica: panoramica attuale e prospettive future.

Electronic cigarettes (e-cigs) are experiencing a great popularity and their market has surprisingly grown in a few years. However, the rapidly evolving phenomenon is raising concerns about the safety and efficacy of these products. Opinions and information from the popular press, but also from the scientific community, are often divergent, confused, warning and sometimes purposely false, raising inconsistent doubts and disproportionate concerns for the public health. This can be easily overcome by the application of rational, plausible, evidence-based regulations for e-cigs. In this short article, we will consider the doubts, evaluate the evidence and formulate some proposals for a more equitable and balanced regulation of these products.

Body dysmorphic disorder and psychotherapeutic interventions: a systematic literature review.

Introduction: Body dysmorphism disorder (BDD) is a disabling mental disorder characterized by an anxious preoccupation with a perceived defect in physical appearance. Objective: This systematic review arose with the main objective of identifying the most effective psychotherapeutic intervention in the treatment of BDD. Methods: From February to October 2022, we conducted a systematic review aimed at identifying the psychotherapeutic intervention for BDD, the search for these concepts was on PubMed. There were no language limitations, only time limitations, we delved into studies published in the databases between 2015 and 2022. Results: We identified a total of 393 unique records. Of these, 43 full-text articles were evaluated for eligibility, and seven of these met the inclusion criteria and were included in the final systematic review. Conclusions: Cognitive-behavioral therapy has been shown to be effective compared with other therapies, especially when combined with drug therapy. The results confirm that BDD-NET (INTERNET-based CBT) led to significant improvement of symptoms in patients with body dysmorphism. In conclusion, we can say that cognitive-behavioral therapy, whether in direct or online form, appears to be the most effective treatment for this disorder.

Breaking the Silence: Exploring Peritraumatic Distress and Negative Emotions in Male and Female Physical Domestic Violence Victims.

Background: Domestic violence is a widespread problem affecting individuals, families, and communities worldwide. Peritraumatic distress is associated with post-traumatic stress disorder and other mental health problems among victims, but research on men's experiences is limited. Objective: We analyzed data from 48 physical domestic violence victims (16 males and 32 females) to compare their levels of peritraumatic distress and negative emotions, and to examine the types of aggressors they faced. Methods: We used descriptives to summarize sample characteristics and Peritraumatic Distress Inventory scores and used statistical tests such as Mann-Whitney U, Shapiro-Wilk, Levene's test, contingency tables, and chi-square to investigate differences and associations between variables. Results: Female victims of domestic violence had significantly higher scores on the Peritraumatic Distress Inventory than male victims and experienced significantly higher levels of negative emotions than male victims, including impotence/inability to react, sadness, anger/frustration, loss of control, fear, guilt, and shame. Husbands and domestic partners were the most frequent aggressors against female victims, while wives and ex-wives were the most frequent aggressors against male victims. In addition, partners were found to be the most frequent type of aggressor in the sample. Descriptive statistics, box plots, and scatter plots were used to provide a clear picture of the sample characteristics. Conclusion: Female victims of domestic violence reported higher levels of peritraumatic distress and negative emotions compared to men victims. Partners were the most frequent type of aggressor in the sample.

Protocol for the "magnitude of cigarette substitution after initiation of e-cigarettes and its impact on biomarkers of exposure and potential harm in dual users" (MAGNIFICAT) study.

Introduction: Many smokers who use e-cigarettes (ECs) to quit continue smoking alongside vaping. The impact on health among individuals who simultaneously smoke conventional cigarettes (CCs) and use ECs remains unclear. The varying patterns of dual use present differing levels of overall toxin exposure and relative risks concerning smoking-related diseases. Understanding these complexities is vital to assessing the implications for human health. Objective: Herein we describe a protocol designed to analyze the impact of different level of substituting CCs with ECs on exposure to toxicants. We'll use biomarkers to measure this exposure and assess harm reduction in dual users through clinical endpoints, harm-related biomarkers, and behavioral correlations. We expect to observe progressive changes with varying patterns of dual use. Methods and analyses: For this purpose, we planned to recruit a group of 250 smokers who will be asked to reduce their CC consumption by adopting ECs (intervention group). A separate group of 50 smokers will continue to smoke CC (reference group). Study groups will be followed up for 6 months during which biospecimens will be collected for biomarker analyses, and clinical endpoints will be assessed. The trial is structured to characterize subjects' usage patterns over time using robust biomarkers of exposure and a standardized mobile phone application to facilitate the precise categorization of dual users along the risk continuum based on their usage behaviors. Subject recruitment will start in February 2024 and enrolment is expected to be completed by August 2024. Results will be reported early in 2025. Study findings may provide valuable insights into health benefits or risks associated with varying patterns of dual use. Ethics and dissemination: The study protocol and informed consent forms will be approved by the local Ethical Review Boards. Study results will be disseminated through articles published in reputable, peer-reviewed, open access, scientific journals, presentations at conferences, and the University website.

Psychological and neuropsychological clinical impact in brain cancer patients and evidence-based psychological intervention: a systematic review of the literature.

Background: Cancer patients may suffer from psychological disorders related to their health condition. Various medical, surgical, and interventional procedures, alongside the distinct tumor localization, have been linked to an elevated predisposition towards psychological disorders, including but not limited to depression, anxiety, post-traumatic stress disorder (PTSD), and cognitive impairments. Objective: To systematically review the literature on neurocognitive rehabilitation of patients before and after brain cancer. Methods: The systematic review was performed according to the PRISMA 2020 guidelines for the systematic review of the PRISMA Group. The literature search was conducted from February 2022 to December 2022 in the databases of PubMed, APA PsycNet, and Web of Science. The focus was on cognitive-behavioural treatments, with Goal Management Training (GMT), and also an app on the iPad- ReMind- that includes psychoeducation, strategy training, and retraining, and new technologies such as virtual reality, in patients with cognitive deficits after neurosurgery. Conclusions: Overall, neurocognitive rehabilitation had an improvement on cancer patients and a recovery of executive and cognitive functions, a better quality of life, and psychological well-being.

Tobacco Smoking or Nicotine Phenotype and Severity of Clinical Presentation at the Emergency Department (SMOPHED): Protocol for a Noninterventional Observational Study.

BACKGROUND: In the last few years, several nicotine products have become available as alternatives to smoking tobacco. While laboratory and limited clinical studies suggest that these devices are less toxic compared to classic tobacco cigarettes, very little is known about their epidemiological impact. Visiting the emergency department (ED) often represents the first or even the only contact of patients with the health care system. Therefore, a study conducted at the ED to assess the impact of these products on health can be reliable and reflect a real-life setting. OBJECTIVE: The aim of this noninterventional observational study (SMOPHED study) is to analyze the association between the severity of clinical presentation observed during ED visits among patients using various nicotine products and the subsequent outcomes, specifically hospitalization and mortality. METHODS: Outcomes (hospitalization and mortality in the ED) will be examined in relation to various patterns of nicotine products use. We plan to enroll approximately 2000 participants during triage at the ED. These individuals will be characterized based on their patterns of tobacco and nicotine consumption, identified through a specific questionnaire. This categorization will allow for a detailed analysis of how different usage patterns of nicotine products correlate with the clinical diagnosis made during the ED visits and the consequent outcomes. RESULTS: Enrollment into the study started in March 2024. We enrolled a total of 901 participants in 1 month (approximately 300 potential participants did not provide the informed consent to participate). The data will be analyzed by a statistician as soon as the database is completed. Full data will be published by December 2024. CONCLUSIONS: There is substantial debate about the harm reduction potential of alternative nicotine products in terms of their smoking-cessation and risk-reduction potential. This study represents an opportunity to document epidemiological data on the link between the use of different types of nicotine products and disease diagnosis and severity during an ED visit, and thus evaluate the harm reduction potential claims for these products. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/54041.

A multicenter prospective randomized controlled trial investigating the effects of combustion-free nicotine alternatives on cardiovascular risk factors and metabolic parameters in individuals with type 2 diabetes who smoke: the DiaSmokeFree study protocol.

Stopping smoking is crucial for public health and especially for individuals with diabetes. Combustion-free nicotine alternatives like e-cigarettes and heated tobacco products are increasingly being used as substitutes for conventional cigarettes, contributing to the decline in smoking prevalence. However, there is limited information about the long-term health impact of those products in patients with diabetes. This randomized controlled trial aims to investigate whether switching from conventional cigarettes to combustion-free nicotine alternatives will lead to a measurable improvement in cardiovascular risk factors and metabolic parameters over a period of 2 years in smokers with type 2 diabetes. The multicenter study will be conducted in seven sites across four countries. A total of 576 smokers with type 2 diabetes will be randomly assigned (1:2 ratio) to either standard of care with brief cessation advice (Control Arm) or combustion-free nicotine alternatives use (Intervention Arm). The primary end point is the change in the proportion of patients with metabolic syndrome between baseline and the 2-year follow-up. Additionally, the study will analyze the absolute change in the sum of the individual factors of metabolic syndrome at each study time point. Patient recruitment has started in September 2021 and enrollment is expected to be completed by December 2023. Results will be reported in 2026. This study may provide valuable insights into cardiovascular and metabolic health benefits or risks associated with using combustion-free nicotine alternatives for individuals with type 2 diabetes who are seeking alternatives to tobacco cigarette smoking. The study protocol, informed consent forms, and relevant documents were approved by seven ethical review boards. Study results will be disseminated through articles published in high-quality, peer-reviewed journals and presentations at conferences.

A Global Health Survey of People Who Vape but Never Smoked: Protocol for the VERITAS (Vaping Effects: Real-World International Surveillance) Study.

BACKGROUND: There is only limited information about the health effects of regular vaping. Research on the health status of people who used to smoke faces the challenge that previous smoking may have caused unknown health effects. Only studies of people who vape but have never smoked combustible cigarettes can enable the detection of harms attributable to vaping. Large prospective studies of well-characterized electronic cigarette users with and without a history of combustible cigarette smoking are warranted to establish the long-term effects of regular vaping on respiratory health. OBJECTIVE: We will conduct a global cross-sectional survey of individuals from 6 world regions. Respiratory symptoms will be assessed using a validated questionnaire-the Respiratory Symptom Experience Scale (RSES). Current vapers who are nonusers of other tobacco or nicotine products will be compared with matched controls who are nonusers of vapes and other tobacco or nicotine products. METHODS: This will be a multicountry, cross-sectional internet-based survey of 750 adults aged ≥18 years who satisfy the criteria for inclusion in either a cohort of people who exclusively vape and who are nonusers of other tobacco or nicotine products ("vapers cohort"; target N=500) or a cohort of nonvapers who are also nonusers of other tobacco or nicotine products ("controls cohort"; target N=250). The primary end point of the study is the RSES score. RSES scores of people in the "vapers cohort" will be compared with those of people in the "controls cohort." Additionally, the study will collect data to characterize patterns of vaping product use among the vapers cohort. Data collection will include information about the age initiation of using vape products, reasons for starting and continuing the use of vape products, specific types of products used, flavors and nicotine strengths of recently used products, as well as the frequency and intensity of product use in the past 30 days. RESULTS: Participant recruitment started in April 2023, and enrollment was completed by November 2023 with 748 participants. Results will be reported in 2024. CONCLUSIONS: This will be the first study providing key insights into respiratory health effects associated with using electronic cigarettes in people who vape with no established use of combustible cigarettes or other tobacco or nicotine products. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/54236.

Changes in Oral Health and Dental Esthetic in Smokers Switching to Combustion-Free Nicotine Alternatives: Protocol for a Multicenter and Prospective Randomized Controlled Trial.

BACKGROUND: Although the detrimental effects of conventional combustible cigarettes on oral health and dental esthetics are well known, there is limited information about the long-term impact of combustion-free nicotine alternatives (C-F NA) such as e-cigarettes or heated tobacco products. OBJECTIVE: This multicenter, prospective, 3-parallel-arm randomized controlled trial will investigate whether switching from combustible cigarettes to C-F NA will lead to measurable improvements in oral health parameters and dental esthetics over 18 months in adult smokers with limited gum disease. METHODS: Regular smokers not intending to quit and without clinical signs of periodontitis will be randomly assigned (1:4 ratio) to either standard of care with brief cessation advice (control group; arm A) or C-F NA use (intervention group; arm B). The study will also include a reference group of never smokers (reference group; arm C). The primary end point is the change in the Modified Gingival Index (MGI) score from baseline between the control arm (arm A) and the intervention arm (arm B) at the 18-month follow-up. In addition, the study will analyze the within- and between-group (arms A, B, and C) changes in MGI assessment, plaque imaging, dental shade quantitation, tooth stain scores, and oral health-related quality of life questionnaires measured at each study time point. All participants will attend a total of 7 clinic visits: screening, enrollment, and randomization (visit 0); baseline visit-day 14 (visit 1); day 90 (visit 2); day 180 (visit 3); day 360 (visit 4); and day 540 (visit 5). This multicenter study will be conducted in 4 dental clinics in 4 countries. The statistical analysis will involve descriptive statistics for continuous and categorical data. Primary end points will undergo tests for normality and, based on distribution, either a 2-sided t test or Mann-Whitney U test. Linear mixed model with random factors center and study arms by center will also be applied. Secondary end points, including MGI assessment and quality of life, will be subjected to similar tests and comparisons. Only if one value of the parameter MGI is missing after day 1, the last available observation will be carried forward. The analysis will be performed on the substituted data. Secondary parameters will not have missing value replacement. RESULTS: Participant recruitment began in October 2021, and enrollment was completed in June 2023. Results will be reported in 2025. CONCLUSIONS: This will be the first study to provide key insights into oral health benefits or risks associated with using C-F NA in smokers who are seeking alternatives to cigarette smoking. TRIAL REGISTRATION: ClinicalTrials.gov NCT04649645; https://clinicaltrials.gov/ct2/show/NCT04649645. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/53222.

Behavioral Therapy for People With Diabetes Who Smoke: A Scoping Review.

BACKGROUND: Tobacco smoking exacerbates diabetes-related complications; its prevalence is notwithstanding substantial. Persons with diabetes face a number of barriers and challenges to quitting such as multiple lifestyle restrictions; tailored interventions are required for smoking cessation. OBJECTIVE: To identify research on behavioral interventions for smoking cessation in diabetes. METHODS: Studies had to be randomized controlled trials, quasiexperimental or systematic reviews. The behavioral interventions included were: the 5As, Cognitive-Behavioral Therapy, Motivational Interviewing, Contingency Management, Health Coaching and Counselling, as compared to standard care. The outcomes were self-reported and/or biochemically verified smoking cessation. CINAHL Complete, MEDLINE Complete, the Cochrane databases of systematic reviews and randomized controlled trials, PsychInfo and PubMed Central were searched until July, 2023. Keywords used included diabetes, smoking cessation and each of the behavioral interventions included. RESULTS: 1615 papers were identified. Three studies on the 5As/brief advice, 4 on Motivational Intervention and 1 on counseling were retained. The results on the 5As and Motivational Interviewing were conflicting. More intensive interventions appear to be more successful in achieving smoking cessation in smokers with diabetes. CONCLUSIONS: Future research should focus on the continued development and evaluation of structured smoking cessation interventions based on the 5As, Motivational interviewing and Cognitive Behavioral Therapy.