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.

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.

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.

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.

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.

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.

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.

PERCEPTIONS AND EXPERIENCES OF M-HEALTH TECHNOLOGIES AND SOCIAL MEDIA: A QUALITATIVE STUDY IN PATIENTS WITH SCHIZOPHRENIA.

The growing influence of technology in the realm of mental health presents promising prospects for patients with psychiatric disorders like schizophrenia. The objective of this study is to investigate the perceptions of individuals with schizophrenia spectrum disorder regarding the utilization of technology and social media. The qualitative methodology used consists of an individual structured interview and the data were subjected to thematic analysis. The results show that the participants use digital tools for various activities such as work, searching for information, entertainment, and socialising. Their perceptions confirm the usefulness and easy accessibility of these tools, which enable positive changes in the organisation of daily life and social relationships. In general, it is possible to identify both positive and negative aspects of technology and social media, such as abuse and addictive behaviour, network and information overload problems, and the risk that privacy may not be guaranteed; among the positive ones, the promotion of remote sociability, speed in carrying out tasks and acquiring useful information emerge. Most of the participants express a positive perception of the possibility that digital tools can help in the field of mental health.

User evaluation and feasibility test of an app designed for smoking cessation in Italian people who smoke: preliminary findings from an uncontrolled pre-test post-test open study.

BACKGROUND: mHealth is a public health practice that exploits the use of mobile devices, including smartphone applications. We will describe an uncontrolled pre-test post-test open pilot study concerning the feasibility evaluation of a smartphone App designed to help in smoking cessation. The aim of this study is to evaluate the feasibility of a smartphone app as a tool for smoking cessation. This study is necessary to the literature because smoking is a major public health concern and has been linked to various health issues such as cardiovascular disease, respiratory disease, and cancer. While there are several smoking cessation interventions available, the use of mobile devices to aid in smoking cessation is a relatively new and innovative approach that requires further investigation. METHODS: The App "Smoke Free" was configured on the devices of N = 30 participants who smoked combustible cigarette, 13 males and 17 females aged 18 to 55 years, with the indications to use it for 90 days, describe their experience, suggest new features, and report any critical aspect. The study consisted of an initial screening visit to select participants that reflected the inclusion criteria and 4 study visits: a baseline visit, two follow-up visits, and one final visit. We used descriptive stats to summarize results. Repeated measures ANOVA and Wilcoxon test were used to test differences in smoking consumption, self-reported craving, and measured eCO level. Statistical software Jamovi was used for analysis. Interviews were conducted via phone or in-person and analyzed using qualitative description principles. RESULTS: Participants evaluated the app as having good aesthetic appeal and user-friendliness but being moderately useful, despite some quitting or reducing their smoking behavior. To improve it, participants have proposed features such as more notifications, social network integration, and damage caused by smoking to the body over time for future app updates. CONCLUSIONS: The application was moderately useful with good feasibility, with several suggestions for future updates that could improve its effectiveness.

Mental Pain Correlates with Mind Wandering, Self-Reflection, and Insight in Individuals with Psychotic Disorders: A Cross-Sectional Study.

Understanding the cognitive processes that contribute to mental pain in individuals with psychotic disorders is important for refining therapeutic strategies and improving patient outcomes. This study investigated the potential relationship between mental pain, mind wandering, and self-reflection and insight in individuals diagnosed with psychotic disorders. We included individuals diagnosed with a 'schizophrenia spectrum disorder' according to DSM-5 criteria. Patients in the study were between 18 and 65 years old, clinically stable, and able to provide informed consent. A total of 34 participants, comprising 25 males and 9 females with an average age of 41.5 years (SD 11.5) were evaluated. The Psychache Scale (PAS), the Mind Wandering Deliberate and Spontaneous Scale (MWDS), and the Self-Reflection and Insight Scale (SRIS) were administered. Statistical analyses involved Spearman's rho correlations, controlled for potential confounders with partial correlations, and mediation and moderation analyses to understand the indirect effects of MWDS and SRIS on PAS and their potential interplay. Key findings revealed direct correlations between PAS and MWDS and inverse correlations between PAS and SRIS. The mediation effects on the relationship between the predictors and PAS ranged from 9.22% to 49.8%. The largest statistically significant mediation effect was observed with the SRIS-I subscale, suggesting that the self-reflection and insight component may play a role in the impact of mind wandering on mental pain. No evidence was found to suggest that any of the variables could function as relationship moderators for PAS. The results underscore the likely benefits of interventions aimed at reducing mind wandering and enhancing self-reflection in psychotic patients (e.g., metacognitive therapy, mindfulness). Further research will be essential to elucidate the underlying mechanisms.

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.

Love Addiction - Current Diagnostic and Therapeutic Paradigms in Clinical Psychology. (v2).

Background: We have investigated and analyzed the latest research on love addiction in the fields of clinical psychology, diagnosis, psychotherapy and treatment. Methods: From 30 November 2021 to July 2022 a review was conducted aimed at identifying the current diagnostic paradigms associated with this new behavioral dependence, investigating in depth what has not yet emerged, searching for strong and weak correlations with related theoretical constructs, comorbidities, investigate which evaluation scales are currently used and outline a guiding design that allows you to move between current scientific discoveries, searching for relevant studies in the databases PubMed, National Center for Biotechnology Information (NCBI), PsycINFO, MDPI, APA, ScienceDirect, and ReserchGate. Results: We identified a total of 102 unique articles. Among these, 22 full-text articles were assessed for eligibility and 5 of these met the eligibility criteria and were, therefore, included in the final systematic review. Conclusions: Group psychotherapy has proved to be a valid alternative, in fact the scientific landscape suggests that most group therapies are successful because these dynamics involve the reward and attachment systems in the brain in most subjects. Although there is currently no official classification for this type of addiction, the continuing interests of clinical psychology open up new scenarios for achieving greater psychophysical well-being.

A Clinical Psychological View about Delusional Characterizations in Subjects with Schizophrenia Spectrum Disorder during the COVID-19 Period.

(Background) The period experienced during the COVID-19 virus and the respective social regulations associated with it caused enormous psychosocial stress. (Objective) The objective of the present work was to observe whether the lived period induced a change in delusional characterizations in subjects with schizophrenia spectrum disorder. (Methods) A systematic literature review was conducted following the PRISMA 2020 guidelines for systematic reviews of the PRISMA GROUP. The literature search was conducted from November 2021 to May 2022, using various scientific platforms including PubMed. (Results) A total of 865 articles were found, from which 176 duplicates were removed. The remaining articles were reviewed by reading the titles and abstracts; fourteen were included. (Conclusions) During this research, it was possible to confirm the initial thesis, namely that delirium absorbs external reality by being modified by it. It was observed that the speed of absorption is estimated to be directly proportional to the speed of the modification of social reality and to the impact that the latter has on the subject's private sphere. Moreover, the situation of radical change represented a condition of abnormal psychosocial stress, which led to an increase in diagnoses of schizophrenia spectrum disorders and, specifically, a weighty increase in diagnoses of brief psychotic disorder (BDP). In the coming years, it is estimated that there will be an increase in diagnoses of schizophrenia spectrum disorder caused by both environmental and biological factors.

Comparing the Effectiveness, Tolerability, and Acceptability of Heated Tobacco Products and Refillable Electronic Cigarettes for Cigarette Substitution (CEASEFIRE): Randomized Controlled Trial.

BACKGROUND: People who smoke and who face challenges trying to quit or wish to continue to smoke may benefit by switching from traditional cigarettes to noncombustible nicotine delivery alternatives, such as heated tobacco products (HTPs) and electronic cigarettes (ECs). HTPs and ECs are being increasingly used to quit smoking, but there are limited data about their effectiveness. OBJECTIVE: We conducted the first randomized controlled trial comparing quit rates between HTPs and ECs among people who smoke and do not intend to quit. METHODS: We conducted a 12-week randomized noninferiority switching trial to compare effectiveness, tolerability, and product satisfaction between HTPs (IQOS 2.4 Plus) and refillable ECs (JustFog Q16) among people who do not intend to quit. The cessation intervention included motivational counseling. The primary endpoint of the study was the carbon monoxide-confirmed continuous abstinence rate from week 4 to week 12 (CAR weeks 4-12). The secondary endpoints included the continuous self-reported ≥50% reduction in cigarette consumption rate (continuous reduction rate) from week 4 to week 12 (CRR weeks 4-12) and 7-day point prevalence of smoking abstinence. RESULTS: A total of 211 participants completed the study. High quit rates (CAR weeks 4-12) of 39.1% (43/110) and 30.8% (33/107) were observed for IQOS-HTP and JustFog-EC, respectively. The between-group difference for the CAR weeks 4-12 was not significant (P=.20). The CRR weeks 4-12 values for IQOS-HTP and JustFog-EC were 46.4% (51/110) and 39.3% (42/107), respectively, and the between-group difference was not significant (P=.24). At week 12, the 7-day point prevalence of smoking abstinence values for IQOS-HTP and JustFog-EC were 54.5% (60/110) and 41.1% (44/107), respectively. The most frequent adverse events were cough and reduced physical fitness. Both study products elicited a moderately pleasant user experience, and the between-group difference was not significant. A clinically relevant improvement in exercise tolerance was observed after switching to the combustion-free products under investigation. Risk perception for conventional cigarettes was consistently higher than that for the combustion-free study products under investigation. CONCLUSIONS: Switching to HTPs elicited a marked reduction in cigarette consumption among people who smoke and do not intend to quit, which was comparable to refillable ECs. User experience and risk perception were similar between the HTPs and ECs under investigation. HTPs may be a useful addition to the arsenal of reduced-risk alternatives for tobacco cigarettes and may contribute to smoking cessation. However, longer follow-up studies are required to confirm significant and prolonged abstinence from smoking and to determine whether our results can be generalized outside smoking cessation services offering high levels of support. TRIAL REGISTRATION: ClinicalTrials.gov NCT03569748; https://clinicaltrials.gov/ct2/show/NCT03569748.

Psychological Experience of Smoking Addiction in Family and Friends of Schizophrenic Adults Who Smoke Daily: A Qualitative Study.

The smoking addiction of patients with severe mental disorders has consequences not only for the patients but also for the people around them. This is qualitative research on family and friends of patients with Schizophrenia spectrum disorders to investigate their perception and vision of smoking, its impact on the patients' physical and mental health, and the possible attempts to combat addiction. The research also investigates the participants' views on electronic cigarettes as a means of replacing traditional cigarettes and helping the patient to quit smoking. The survey method used was a semi-structured interview. The answers were recorded, transcribed and analyzed with the technique of thematic analysis. The results of this study show that the view of most participants on smoking is negative (83.3%), although not all of them consider smoking cessation treatments for these patients of primary importance (33.3%). Nevertheless, a good number of them have tried to intervene spontaneously with their own resources and strategies (66.6%). Finally, low-risk products, and in particular electronic cigarettes, are considered by many participants as a useful alternative to traditional cigarettes in patients with schizophrenia spectrum disorders. About the meaning that cigarettes can assume for the patient, recurring themes emerge: they are considered as a way to manage nervousness and tension or as a means to contrast daily monotony and boredom or repeat usual gestures and habits.

Qualitative study on the perception of combustible cigarettes, e-cigarettes and heated tobacco cigarettes among pregnant women.

The research proposes to investigate the psychological reasons that may explain women's addiction to smoking during pregnancy and the perception of combustible cigarettes, electronic cigarettes and heated tobacco cigarettes. The sample included 30 participants who smoke or people who previously smoked who chose to quit or continue smoking during pregnancy. The data was gathered via a semi-structured interview and developed from three research questions: feelings, opinions and perceptions of pregnant women toward e-cigarettes, heated tobacco cigarettes, and combustible cigarettes. The study used thematic qualitative analysis for the methodological formulation of the results. The Standards for Reporting Qualitative Research Standards (QRRS) checklist was used. In this qualitative research, three psychological reasons for the onset of smoking were found and analyzed: feelings of stress, nervousness, and loneliness. According to the results: 40.91% of the women who smoked combustible cigarettes decided to keep on smoking and 59.09% decided to quit, 16.67% of participants who use heated tobacco cigarette decided to continue during pregnancy and the remaining 83.33% decide to stop; lastly, there is a condition of fairness for adults who use e-cigarette, 50% decided to continue smoking during pregnancy and the other 50% decided to stop smoking. The data indicate that those who continue to smoke during pregnancy are participants who smoke combustible cigarettes, stating that they reduce the amount of smoke inhaled. Meanwhile, participants who use heated tobacco cigarettes or e-cigarettes are certain that they pose less risk than combustible cigarettes; nevertheless, most of them decide to quit smoking during pregnancy. Another important aspect that has been noted is that of formal abandonment treatments, as quite unexpectedly, there has been a unanimous recognition of strong distrust toward the possible risks to the unborn child. There is a lot of distrust and little knowledge of official smoking cessation therapies, and because of this, participants stated that they can quit smoking whenever they want and only with their own willpower. Five categories and related themes emerged from the thematic analysis, such as reasons for starting with themes such as stress, irritation, loneliness, adolescence and integration; reasons for attachment to topics such as habit and carelessness about one's health; perceptions of traditional cigarettes compared to e-cigarettes and heated cigarettes with related topics such as sensory experiences and side effects; feelings and use of official smoking cessation therapies with issues as willpower and knowledge; information on the effects of smoke during pregnancy and breastfeeding, including risk information.

Development and User Evaluation of a Food-recognition app (FoodRec): Experimental Data and Qualitative Analysis.

Background: different studies revealed strong correlation between smoking cessation and a worsening of the diet, whose consequence include loss of appetite, weight loss, etc. Objective: the objective of FoodRec project is to exploit technology to monitor the dietary habits of people during their smoke quitting process, catching relevant changes which can affect the patient health and the success of the process. This work was an uncontrolled pre-test post-test open pilot study in which an interdisciplinary group created an app for food recognition (FoodRec) to monitor their mood status and dietary habits during the test period. Methods: participants used the FoodRec App for two consecutive weeks for usability and suitability assessment. Tests included 149 smokers involved in a smoke quitting process, aged between 19 and 80. For the quantitative test, data were analyzed regarding users features, meals uploads, mood states and drink intakes. For the qualitative test, a user evaluation test of the app has been performed with four assignments being carried out on a group of 50 participants. Results: the App was perceived as extremely user-friendly and lightweight. It also turned out to be useful in the perception of users' dietary habits and helpful in relieving the stress of a food intake reduction process. Conclusion: this work investigated the role and impact of the FoodRec App in a large international and multicultural context. The experience gained in the current study will be used to modify and refine the large international RCT protocol version of the app.