Implications of Switching from Conventional to Electronic Cigarettes on Quality of Life and Smoking Behaviour: Results from the EQualLife Trial.

INTRODUCTION: Electronic cigarettes and "vaping" have become popular since their appearance in Europe and the USA in approximately 2006. They are often perceived as having fewer health risks than conventional cigarettes, which makes them of interest as a support tool in smoking cessation. However, its efficacy regarding cessation or reduction of smoking under real-life conditions remains controversial. Our objective was to clarify this question in an observational study of smoking habits after initiating vaping without targeted intervention, as compared to a validated cessation programme. METHODS: From October 2015 to April 2018, 80 subjects (60 in the e-cigarette group and 20 in the supervised smoking cessation group) were included in two trial visits, one at the start of the trial and the second after 3 months, plus 4 questionnaire surveys: at the start of the trial and after a 1, 2, and 3 month period. The questionnaire included a nicotine use inventory, a modified Fagerström test for nicotine dependence, and the WHO-QOL-BREF survey. RESULTS: E-cigarettes were effective, leading to a significant (p < 0.03) reduction (p < 0.03) in tobacco consumption and nicotine dependence, with an abstinence rate of 43% after 3 months. Compared to participants in the smoking cessation programme, their use was not associated with an improvement in quality of life during the quitting attempt, and there were no significant differences in clinical symptoms between groups. The reduction in nicotine dependence was more pronounced (p < 0.012) for the smoking cessation programme, with higher abstinence rates (p = 0.011 after 12 weeks) and lower (p < 0.003) remaining tobacco consumption compared to electronic cigarettes. DISCUSSION/CONCLUSIONS: The use of electronic cigarettes reduced nicotine dependence and tobacco consumption, but a supervised smoking cessation programme was superior in terms of achieved cessation in both regards. Electronic cigarettes did not improve the quality of life. Since e-cigarettes could be associated with long-term health risks, their usefulness in smoking cessation remains questionable, and a professionally guided and validated smoking cessation programme still appears to be superior and preferable, in terms of achieved cessation. Although this trial is limited regarding the number of participants and follow-up time, it highlights the need for additional, large clinical trials evaluating the efficacy of e-cigarettes for smoking cessation in comparison to a professionally guided smoking cessation programme.

Transcranial direct current stimulation combined with a brief intervention for smoking cessation: a randomized double-blind clinical trial.

Non-invasive brain stimulation methods are currently being evaluated for treatment of addictive disorders. Some evidence indicates that modulating left and right prefrontal brain activity by transcranial direct current stimulation (tDCS) can reduce craving and relapse rates in tobacco addiction. Therefore, this study investigated the effects of active and sham tDCS as an add-on treatment to a standardized brief intervention for smoking cessation. This randomized, double-blind study included 36 participants (22 women and 14 men) with nicotine dependence according to ICD-10 criteria. At five visits on alternate days, participants underwent a 20-min active or sham tDCS over the left dorsolateral prefrontal cortex and subsequently participated in a 10-min brief intervention for smoking cessation. Patients were followed up after 3 months. On each treatment day and at follow-up, abstinence was assessed as the smoking status nonsmoker and craving was assessed with the German version of the Questionnaire on Smoking Urges. At each visit, the number of cigarettes smoked per day was recorded and carbon monoxide in expired air and cotinine in saliva were measured. At follow-up, a study-specific questionnaire was used to assess tobacco use. All 36 participants completed the treatment sessions, but one participant in each group was lost to follow-up. Abstinence rates were not significantly different between the groups at any of the study visits, but craving was significantly lower in the active group at tDCS session 5 compared with session 1. tDCS combined with a brief intervention may support smoking cessation, but studies need to evaluate whether longer and more intensive treatment can achieve significant, sustainable effects.

[Non-smoker protection and tobacco cessation]. / Nichtraucherschutz und Tabakentwöhnung.

Non-smoker protection and tobacco cessation Abstract. Objective: Whereas, on the one hand, employees in child and adolescent psychiatric institutions (CAP) have to enforce smoking bans among patients, on the other hand, they have a high likelihood of being smokers themselves. Little data are available on the enforcement of smoking regulations and what cessation support is offered by CAP institutions. Method: In an online survey, n = 78 senior staff members or directors of German CAP institutions (41.9 % of all addressed CAP institutions) responded to questions on smoking regulations, exceptions, and cessation support for employees. Results: The enforcement of comprehensive smoking bans is rarely reported (<20 % of CAP institutions). Employees are exempted or allowed to smoke mostly outside of the building (e. g., in designated smoking areas: 69-78 % depending on ward type). Cessation support was offered by less than half of the CAP institutions (47%). Conclusions: The data presented point toward future areas for tobacco control in CAP care, including transparent regulations, staff training, and dissemination of support for occupational smoking cessation.

S3 Guideline "Smoking and Tobacco Dependence: Screening, Diagnosis, and Treatment" - Short Version.

INTRODUCTION: In addition to the prevention of tobacco consumption, the establishment and assurance of high-quality treatment for harmful use and dependence on tobacco products remains an important health-related task in Germany. Regular updating of the Association of the Scientific Medical Societies (AWMF) S3 guideline "Smoking and Tobacco Dependence: Screening, Diagnosis, and Treatment" (Tobacco Guideline) offers a sustainable and reputable source of knowledge on smoking cessation. METHODS: Under the auspices of the German Society for Psychiatry, Psychotherapy, Psychosomatics, and Neurology (DGPPN) and the German Society for Addiction Research and Addiction Therapy (DG-Sucht), the Tobacco Guideline was revised in 2019-2020 by 63 experts, who were involved in the development process of the text, in 11 working groups. Undue influence of conflicts of interest on the guideline could be minimized through careful conflict of interest management. Delegates from 50 professional societies discussed the 80 guideline recommendations and voted online. RESULTS: In addition to recommendations for screening and diagnostics, the Tobacco Guideline takes a positive stance towards the use of low-threshold counseling and support services. If, due to the severity of the tobacco-related disorder, brief counseling, telephone counseling, or internet- or smartphone-based methods are not sufficiently effective, individual or group behavioral therapy, possibly in combination with medication, is indicated. If nicotine replacement therapy is not effective, varenicline or bupropion should be offered. Alternative strategies with a lower level of recommendation are hypnotherapy, mindfulness-based treatments, or medication with cytisine. In adolescents and pregnant women, the use of medication should be limited to well-specified exceptions and nicotine replacement. The mean agreement with the recommendations reached a value of 98%. A general overview of the treatment recommendations of the Tobacco Guideline is provided by three clinical algorithms.

[Chemsex : A new challenge in addiction medicine and infectious diseases]. / Chemsex : Eine neue Herausforderung der Suchtmedizin und Infektiologie.

BACKGROUND: Recently there has been an increase in reports of the phenomenon called chemsex, a subform of sexualized substance use. Chemsex is a neologism consisting of the two terms "chemicals" and "sex". It describes the use of methamphetamine, γ­hydroxybutyrate/γ-butyrolactone (GHB/GBL), mephedrone and sometimes other substances in a sexual context, especially by men who have sex with men (MSM). Chemsex has been described as a significant risk factor for mental and physical diseases. OBJECTIVE: Due to the increasing importance of the phenomenon and the significantly increased number of publications on the subject, this article provides an overview of the current and relevant literature. The aim is to raise awareness on this topic among practitioners and researchers and thus to facilitate access to the help system for those affected. METHOD: A literature search was conducted in PubMed/Medline, Cochrane and Embase for the terms "chemsex", "sexualized drug use" and "slamming. A total of 22 articles were identified as being relevant. RESULTS: In the published literature on chemsex the current focus lies on somatic comorbidities. There is a significantly increased risk of sexually transmitted diseases. Mental illnesses such as depression, substance-induced psychosis and addiction also appear to be a significant consequence of chemsex. An individualized and specialized treatment approach is not yet established. DISCUSSION: The complexity of chemsex with its psychiatric and somatic aspects does not yet appear to be sufficiently reflected by the current data situation; however, due to the mutual influence of these different comorbidities, this patient clientele appears to be particularly at risk in the absence of a specialized treatment option, which is why further research on this topic is needed.

[Implementation of Tobacco Control Strategies in Psychiatric Institutions for Children and Adolescents: an Online Survey of Leading Staff Members]. / Umsetzung von Tabakkontrollmaßnahmen in Einrichtungen der Kinder- und Jugendpsychiatrie: Eine Online-Befragung von leitenden Mitarbeitenden.

OBJECTIVE: Tobacco control measures are relevant also in child and adolescent psychiatric institutions and their implementation in Germany will be assessed in this study. METHODS: In an online survey, n=78 leading staff members responded to standardized questions assessing how smoking in patients was dealt in such institutions. RESULTS: The majority of institutions (70-87%) had smoking bans in the psychiatric clinic buildings and premises. Depending on the type of psychiatric ward, exceptions were in place in the form of a designated smoking area (38%), smoking pavilion (19%), or when patients suffered from certain mental disorders (28%). Documentation of violations of the ban varied with the type of ward (30-79%), while in most cases violations led to consequences (84-93%) including confiscation of smoking utilities (42-63%) or a curfew (25-38%). Smoking cessation aids were reported by 78% of the institutions, most often as consultations (64%). Pharmacological treatments for smoking were provided in inpatient wards (71-83%). One in two institutions documented the result of cessation attempts (54%). Smoking-related working groups (14%) or the use of standardized diagnostic instruments (0-4%) were much less frequently reported. DISCUSSION: We provide a first look at tobacco control policy measures in child and adolescent psychiatric institutions on a national scale. This allows us to derive future areas for tobacco control.

[Potential Savings in Treatment Costs of COPD through Smoking Cessation: Modeling for DMP COPD in Germany - Scientific Action Group on Tobacco Cessation (WAT) e. V.] / Das Einsparpotenzial der Behandlungskosten bei COPD durch Rauchstopp ­ Modellierung für DMP COPD in Deutschland.

Based on real-life data for the stage distribution of COPD patients (GOLD) and the actual stage-related treatment costs in a large nationwide cohort study (COSYCONET) 1, the influence of the reduced smoking rate on treatment costs was determined for the scenario of a reduction in the smoking rate of 26 % in this patient group by 10 percentage points to 16 %. The assumption was made that with a reduced smoking rate, lower stages (I/II) will be more strongly represented, while higher and more cost-intensive stages (III/IV) will be proportionally reduced. The intervention to achieve tobacco abstinence was calculated for the rough model calculations with the typical costs of a guideline-compliant treatment by a behavioral therapy group cessation program and the parallel use of medication support 2 3. The result showed a potential reduction of case costs by 10.5 %, not including reduction in costs associated with treatment of comorbidities.

Evaluation of the cognitive behavioral smoking reduction program "Smoke_less": a randomized controlled trial.

The vast majority of smokers are unable or unwilling to quit, but many are open to reducing smoking. No treatment options exist for these smokers besides medication-based therapies. Thus, this study investigated the efficacy of a cognitive behavioral therapy (CBT) smoking reduction program, Smoke_less. A sample of 155 outpatient smokers aged 18-70 years was recruited at the Tobacco Dependence Outpatient Clinic of the Medical Center of the University of Munich, Germany, and randomly assigned to the experimental group (Smoke_less: four weekly CBT group sessions and two telephone calls over 5 weeks, n = 51), active comparator group (one 15-minute counseling session, n = 49), or waiting control group (no intervention during the study, n = 55). The primary endpoint was a ≥50% smoking reduction in the intention-to-treat group 1 week and 6 months after the intervention. We evaluated also abstinence rates at follow-up. Significantly more participants in the Smoke_less group had reduced smoking ≥50% compared to the waiting group at 1 week [OR 7.59 (2.59-22.19)] and 6 months [OR 5.00 (1.68-14.84)] and compared to the active comparison group at 1 week [OR 8.58 (2.67-27.31)] but not at 6 months [OR 1.73 (0.71-4.20)]. We found no significant effects on abstinence rates. The CBT smoking reduction program Smoke_less is effective for smoking reduction but is superior to brief counseling only in the short term. Further research is required to improve its efficacy in long-term smoking reduction to provide a valid, non-medication-based alternative to smokers unable or unwilling to quit. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT02337400.

A Face-Aging App for Smoking Cessation in a Waiting Room Setting: Pilot Study in an HIV Outpatient Clinic.

BACKGROUND: There is strong evidence for the effectiveness of addressing tobacco use in health care settings. However, few smokers receive cessation advice when visiting a hospital. Implementing smoking cessation technology in outpatient waiting rooms could be an effective strategy for change, with the potential to expose almost all patients visiting a health care provider without preluding physician action needed. OBJECTIVE: The objective of this study was to develop an intervention for smoking cessation that would make use of the time patients spend in a waiting room by passively exposing them to a face-aging, public morphing, tablet-based app, to pilot the intervention in a waiting room of an HIV outpatient clinic, and to measure the perceptions of this intervention among smoking and nonsmoking HIV patients. METHODS: We developed a kiosk version of our 3-dimensional face-aging app Smokerface, which shows the user how their face would look with or without cigarette smoking 1 to 15 years in the future. We placed a tablet with the app running on a table in the middle of the waiting room of our HIV outpatient clinic, connected to a large monitor attached to the opposite wall. A researcher noted all the patients who were using the waiting room. If a patient did not initiate app use within 30 seconds of waiting time, the researcher encouraged him or her to do so. Those using the app were asked to complete a questionnaire. RESULTS: During a 19-day period, 464 patients visited the waiting room, of whom 187 (40.3%) tried the app and 179 (38.6%) completed the questionnaire. Of those who completed the questionnaire, 139 of 176 (79.0%) were men and 84 of 179 (46.9%) were smokers. Of the smokers, 55 of 81 (68%) said the intervention motivated them to quit (men: 45, 68%; women: 10, 67%); 41 (51%) said that it motivated them to discuss quitting with their doctor (men: 32, 49%; women: 9, 60%); and 72 (91%) perceived the intervention as fun (men: 57, 90%; women: 15, 94%). Of the nonsmokers, 92 (98%) said that it motivated them never to take up smoking (men: 72, 99%; women: 20, 95%). Among all patients, 102 (22.0%) watched another patient try the app without trying it themselves; thus, a total of 289 (62.3%) of the 464 patients were exposed to the intervention (average waiting time 21 minutes). CONCLUSIONS: A face-aging app implemented in a waiting room provides a novel opportunity to motivate patients visiting a health care provider to quit smoking, to address quitting at their subsequent appointment and thereby encourage physician-delivered smoking cessation, or not to take up smoking.

[Smoke-free psychiatry in Germany: A closer look]. / Rauchfreie Psychiatrie: Eine Bestandsaufnahme.

OBJECTIVE: In order to protect non-smokers, the federal states of Germany have adopted a law that provides for extensive smoking bans. In many of these federal laws, acute psychiatric facilities are treated as an exception. Therefore, it is often up to the institutions themselves to develop and enforce regulations. The aim of this study was to evaluate the situation in acute psychiatric facilities. METHODS: The survey was created on the basis of previously evaluated questionnaires and consisted of 53 questions. A total of 289 hospitals were contacted. Participants were invited to take part in the survey via e-mail. RESULTS: 59 hospitals (20.4 %) participated in the survey. Binding regulations were in place in 48 (81.4 %) hospitals, in 26 (44.1 %), smoking was prohibited on open wards. Three hospitals (5.1 %) strictly prohibited smoking on locked wards. Stop-smoking medication was available in 31 (55.3 %) hospitals. 19 (32.2 %) offered smoking cessation interventions. 22 (37.3 %) hospitals have set up a working group on the subject. CONCLUSION: Currently, the issue of smoking in psychiatric facilities does not receive enough attention. The physical and mental health of psychiatric patients would benefit from a smoke-free policy. In order to achieve this, psychiatric staff and patients need appropriate support.

Electronic Cigarettes-Attitudes and Use in Germany.

INTRODUCTION: Smoking is the leading preventable cause of death and disease. Previous studies on electronic cigarette (e-cigarette) use have reported reduction and cessation of conventional cigarette smoking; however, health effects are still a matter of discussion. This cross-sectional study investigated the attitudes of adults in Germany towards using e-cigarettes instead of or in addition to cigarettes. Furthermore, it examined the extent to which e-cigarettes are used as a smoking cessation tool. METHODS: In 2012, we recruited a sample of 319 participants comprising e-cigarette users (vapers, 33%), cigarette smokers (smokers, 37%) and smokers of both cigarette types (dual users, 30%). The Integrated Model for Change (I-Change Model) was used as a theoretical framework and a modified Fagerström Test of Nicotine Dependence was used to assess nicotine dependence. Data were collected by means of a questionnaire and smoking status was substantiated by measuring exhaled carbon monoxide. RESULTS: The vapers were more often men, were less addicted to nicotine and had a higher motivation to stop smoking than the smokers. In addition, vapers reported better health and had a lower carbon monoxide concentration than smokers. Furthermore, vapers had a more positive attitude towards e-cigarettes and higher self-efficacy in terms of abstaining from cigarettes in certain situations. CONCLUSIONS: This is the first study to report on the use of e-cigarettes in Germany. Our results support those of previous studies in other populations. Further research is still needed on the potential health effects of e-cigarettes and their efficacy as a smoking cessation aid. IMPLICATIONS: The study is the first description of attitudes and use of e-cigarettes in Germany.

Smoking Cessation Program for Inpatients with Substance Use Disorder: A Quasi-Randomized Controlled Trial of Feasibility and Efficacy.

AIMS: The present study investigated the feasibility, acceptance and efficacy of a newly developed cognitive behavioral program for smoking cessation/reduction ('Rethink your Smoking' program, RSP) in inpatients with substance use disorder (SUD). METHOD: One hundred ninety-nine inpatients with SUD were randomly assigned to either the RSP (n = 101) or a minimal intervention (MI) program (n = 98). In addition, participants were offered optional nicotine replacement therapy. Data from a group of patients with SUD without any intervention (control group, n = 78) were included in the analyses for comparison. Assessments were performed at admission, discharge and follow-up after 3 and 6 months. RESULTS: RSP proved to be feasible and was well accepted by participants. Patients in both interventions showed lower scores for physical nicotine dependence and number of cigarettes smoked per day and higher scores for various motivational parameters at discharge and 3 months later. Both interventions were superior to no intervention, but no differences were found between the RSP and MI. CONCLUSION: A smoking cessation/reduction program is feasible for substance-dependent in-patients undergoing detoxification. Although the RSP appears to be effective in terms of harm reduction in in-patients with SUD, more cost- and time-efficient programs might also be suitable for this population.

Smoking and quality of life in lung cancer patients: systematic review.

OBJECTIVES: Lung cancer (LC) accounts for the largest number of cancer deaths worldwide, with smoking being the leading cause for its development. While quality of life (QoL) is a crucial factor in the treatment of patients with LC, the impact of smoking status on QoL remains unclear. This systematic review aims to provide a comprehensive overview of available evidence on the relationship between smoking status and QoL among patients with LC. METHODS: A systematic search of Embase, Medline and Web of Science was conducted. Studies reporting the impact of smoking status on QoL among patients with LC were eligible for inclusion. Two reviewers independently assessed the eligibility of studies, extracted data and evaluated the risk of bias using the Critical Appraisal Skills Programme appraisal tool for cohort studies. A descriptive synthesis was performed due to the heterogeneity of the studies. RESULTS: A total of 23 studies met the inclusion criteria (17 studies providing cross-sectional and 6 longitudinal data). The studies included a total of 10 251 participants. The results suggested a tendency towards lower QoL among smokers compared with non-smokers. The effect of smoking cessation on QoL was insufficiently investigated in the included studies and therefore remains inconclusive. CONCLUSIONS: The findings of this review suggest that current smokers may experience worse QoL than former and never smokers. The results of this systematic review should, however, be viewed in the context of the difficulty of data collection in this patient group given the low survival rates and low performance status, among other factors and in light of the large variety of different QoL measures used. Future research requires uniform QoL measures, a holistic representation of all patients with LC as well as a comprehensive consideration of all potential determinants of QoL. The potential benefits of smoking cessation on QoL among patients with LC require investigation.

Small pouches, but high nicotine doses-nicotine delivery and acute effects after use of tobacco-free nicotine pouches.

Tobacco-free nicotine pouches are new nicotine products for oral consumption. They can contain very high nicotine amounts that have not been addressed with clinical studies yet. Thus, nicotine delivery, effects on craving, and side effects were assessed using pouches with up to 30 mg nicotine. In this single-center, five-arm, crossover study, 15 regular cigarette smokers consumed tobacco-free nicotine pouches from different brands with 6, 20, and 30 mg for 20 min. Comparators were nicotine-free pouches and tobacco cigarettes. At baseline and predefined time points over a study period of 240 min, plasma nicotine concentrations, effects on cigarette craving, and side effects were assessed. Cardiovascular parameters including arterial stiffness were measured using a MobilOGraph. Consumption of 30 mg nicotine pouches has led to a higher nicotine uptake compared with the cigarette (Cmax: 29.4 vs 15.2 ng/mL; AUC: 45.7 vs 22.1 ng/mL × h). Nicotine uptake in the acute phase was rapid during use of the 30 mg pouch and cigarette. Extraction rate of nicotine differed between pouches. Use of all products has reduced acute cigarette craving, even the nicotine-free pouch. During consumption of the cigarette and the pouches with 20 and 30 mg, heart rate increased about 27, 12, and 25 bpm, respectively. Parameters for arterial stiffness were elevated and all pouches have induced mouth irritations. The pouches with 30 mg nicotine had overall the strongest side effects and may induce addiction. As craving was also reduced by products with less nicotine, it is questionable whether such high nicotine contents should be allowed on the market. A limit of nicotine content is warranted. The nicotine release rate varies across products and needs to be known to estimate the nicotine delivery.

Lethal Lust: Suicidal Behavior and Chemsex-A Narrative Review of the Literature.

Chemsex is described as the use of certain drugs-commonly methamphetamine, gamma-butyrolactone (GBL)/gammahydroxybutyrate (GHB), and mephedrone-before or during planned sexual activity primarily among men who have sex with men (MSM). Evidence shows that MSM who engage in chemsex are at increased risk of physical harm, such as sexually transmittable infections (STIs), and are more likely to experience mental health symptoms. To further assess this, we reviewed the recent literature to evaluate whether the psychological impact of chemsex behavior includes suicidal ideation and suicidal attempts. Pubmed/MEDLINE was searched for articles reporting suicidal ideation and behavior among chemsex users with the terms "chemsex", "sexualized drug use", "suicide", and "mental health". Twelve articles (three case reports and nine cross-sectional studies) were included in the final narrative review. Overall, we retrieved mixed results regarding the relationship between chemsex practice and suicidality outcomes. Considering the inhomogeneous nature of the studies, the findings indicate that suicidality could be an issue of concern among MSM in general but among chemsex users in particular. Possible risk factors for suicidality among chemsex participants may include adversities experienced due to one's sexual orientation and an increased risk for HIV and other STI infections and the resulting negative impact on mental well-being. These aspects warrant further investigations.

Chronotype, Social Jetlag, and Nicotine Use.

Late chronotype, which often leads to higher social jetlag (SJL), is strongly associated with the prevalence of smoking. Any circadian disruption, strain, or misalignment, results in people not being able to live according to their biological time as is described by SJL, which we will therefore use as umbrella term. We hypothesized two scenarios potentially explaining the association between smoking and SJL: (A) If smoking delays the clock, circadian phase should advance upon quitting. (B) If people smoke more to compensate the consequences of SJL, circadian phase should not change upon quitting. To distinguish between these two hypotheses, we accompanied participants of a smoking cessation program (not involving nicotine replacement products) across the cessation intervention (3 weeks prior and 6 weeks after) by monitoring their circadian behavior, sleep quality, and daytime sleepiness via questionnaires and actimetry. Our results show no effects of cessation on SJL, chronotype, sleep quality, or daytime sleepiness, thereby favoring scenario (B). Thus, smoking may be a consequence of rather than a cause for SJL. Daytime sleepiness was a significant predictor for the outcome in our model but did not improve with cessation.

Two Different Heated Tobacco Products vs. Cigarettes: Comparison of Nicotine Delivery and Subjective Effects in Experienced Users.

Heated tobacco products (HTPs) produce aerosol using a different mechanism than tobacco cigarettes, leading to lower emissions of some harmful substances, but also of nicotine as reported by some independent studies. Lower nicotine delivery could lead to compensatory puffing when product use does not sufficiently satisfy cravings. Thus, this three-arm crossover study was conducted to characterize the potential of two different HTPs to deliver nicotine and satisfy cravings compared with conventional cigarettes in users who had already switched to HTPs. Fifteen active, non-exclusive HTP users consumed the study products according to a pre-directed puffing protocol. At predetermined time points, venous blood was sampled and the subjective effects of consumption were assessed. Nicotine delivery by both HTPs was comparable, but significantly lower than that by conventional cigarettes, suggesting a lower addictive potential. Cravings were reduced by all products, with no statistically significant differences between them, despite the different nicotine deliveries. This indicated that HTPs do not necessarily need high nicotine deliveries with high addictive potential, as are characteristic of tobacco cigarettes. These results were followed up on with an ad libitum use study.

Usage Pattern and Nicotine Delivery during Ad Libitum Consumption of Pod E-Cigarettes and Heated Tobacco Products.

Many different nicotine delivery products, such as e-cigarettes (e-cigs) or heated tobacco products (HTPs), are available on the market. To better understand these products, it is crucial to learn how consumers use them and how much nicotine they deliver. Therefore, a pod e-cig, an HTP, and a conventional cigarette (CC) were each used by 15 experienced users of the respective product category for 90 min without special use instructions ("ad libitum"). Sessions were video recorded to analyze usage patterns and puff topography. At defined time points, blood was sampled to determine nicotine concentrations, and subjective effects were inquired about using questionnaires. During the study period, the CC and HTP groups averaged the same number of consumption units (both 4.2 units). In the pod e-cig group, the highest number of puffs was taken (pod e-cig 71.9; HTP: 52.2; CC: 42.3 puffs) with the most extended mean puff duration (pod e-cig: 2.8 s; HTP: 1.9 s; CC: 1.8 s). Pod e-cigs were predominantly used with single puffs or in short clusters of 2-5 puffs. The maximum plasma nicotine concentration was highest for CCs, followed by HTPs, and then pod e-cigs with 24.0, 17.7, and 8.0 ng/mL, respectively. Craving was reduced by all products. The results suggest that the high nicotine delivery known for tobacco-containing products (CCs and HTPs) may not be needed for non-tobacco-containing products (pod e-cigs) to satisfy cravings in experienced users.

Cardiovascular functions and arterial stiffness after JUUL use.

INTRODUCTION: The rapid growth in the e-cigarette market after the launch of JUUL e-cigarettes led to much discussion on the potential benefits and risks of pods, JUUL devices, and conventional e-cigarettes compared with combustible cigarettes. Independent data are required to assess the effects of these products on cardiovascular surrogate parameters and cardiovascular risk. METHODS: We conducted a single-center three-arm study comparing combustible cigarettes with JUUL e-cigarettes with the old and new technology. We recruited 32 participants who were active smokers (n=15) or vapers (n=17) and performed a total of 39 measurements before and 5, 15, and 30 minutes, after participants smoked a combustible cigarette or vaped a JUUL e-cigarette with the new or old technology. Measurements included peripheral and central blood pressures and parameters of arterial stiffness, including pulse wave velocity and augmentation index. RESULTS: Peripheral systolic blood pressure, central blood pressure, and peripheral pulse rate increased significantly in all three groups (each p<0.05). Heart rate (HR) changes lasted significantly longer than blood pressure changes. The augmentation index and pulse wave velocity increased in all three groups, and a multivariate analysis of variance showed that the increases were independent of systolic blood pressure, sex, age, device, and HR. CONCLUSIONS: Changes in blood pressure and arterial stiffness are similar after cigarette smoking and JUUL use. These changes may be associated with an increased cardiovascular risk compared with no product use. However, a long-term follow-up evaluation of JUUL use and a head-to-head comparison with conventional e-cigarettes are still needed.

Efficacy of approach bias modification as an add-on to smoking cessation treatment: study protocol for a randomized-controlled double-blind trial.

BACKGROUND: Although effective treatments for smoking cessation are available, long-term abstinence is the exception rather than the norm. Accordingly, there is a need for novel interventions that potentially improve clinical outcome. Although implicit information processing biases, for example approach biases for smoking-related stimuli, are ascribed a dominant role in the maintenance of tobacco dependence, these biases are hardly targeted in current treatment. Past research has shown that so-called Approach Bias Modification (AppBM) trainings, aiming to modify this bias, lead to improved long-term abstinence in abstinent alcoholic inpatients when delivered as an add-on to treatment-as-usual. Findings on the efficacy of AppBM in smoking have been inconsistent. The present large-scale clinical trial pursues two goals. First, it aims to investigate the efficacy of AppBM as an add-on to treatment-as-usual in a representative sample of adult smokers. Second, possible mechanisms of change are investigated. METHODS: The study is a randomized-controlled, double-blind, parallel-group superiority trial. We aim at a final sample of at least 336 adult smokers. Participants are allocated with a 1:1:1 allocation ratio to one of the following conditions: (1) treatment-as-usual + AppBM, (2) treatment-as-usual + Sham, (3) treatment-as-usual only. During the add-on training, participants are presented smoking-related and positive pictures and are instructed to respond by either pushing or pulling a joystick, depending on the tilt of the pictures (5○ to the left/right). During AppBM, all smoking-related pictures are tilted in the direction that is associated with pushing, thereby aiming to train an avoidance bias for smoking. All positive pictures are tilted in the direction associated with pulling. During Sham, the contingency is 50/50. Participants are assessed before and after the intervention and at a 6-month follow-up. The primary outcome is prolonged abstinence, and secondary outcomes include smoking-related variables and psychological distress. Additionally, the motivational significance of smoking-related stimuli (i.e., approach bias, valence) is assessed with different experimental tasks (Approach-Avoidance Task; Single Target Implicit Association Test) and psychophysiological measures. DISCUSSION: This is the first large-scale clinical trial investigating the efficacy of AppBM as an add-on in smokers including a TAU only condition. Additionally, it is the first study to systematically investigate potential mechanisms mediating the effects of treatment on clinical outcome. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00019221 , 11/11/2019.