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Background Tobacco use is a leading risk factor for premature mortality. Individuals with mental disorders exhibit a smoking prevalence twice that of the general population and engage in higher levels of tobacco consumption, thereby elevating their risk for tobacco-related health complications. Unlike with other substance use disorders, clinical practice in Germany neglects tobacco dependence as a risk factor prior to the initiation of psychotherapy, despite a clear need for intervention: Prolonged cigarette smoking exacerbates mental health symptoms and influences processes central to psychotherapy, such as implicit cognitive processes and emotion regulation. Moreover, short-term nicotine withdrawal associated with tobacco dependence can undermine motivation, reduce positive reinforcement, and cause emotional instability, potentially hindering efforts to improve mental health or the effectiveness of psychotherapeutic interventions. These factors underscore the importance of integrating smoking cessation strategies prior to formal psychotherapy to optimize the therapeutic process and patient outcomes. This study investigates the effects of initiating an intensified smoking cessation program prior to starting psychotherapy. Main measure outcomes of interest are the degree of tobacco dependence, smoking behavior, and mental health outcomes in smokers with mental disorders. By addressing smoking behavior prior to therapy, this trial seeks to establish a more solid foundation for therapeutic work, potentially improving mental health outcomes and promoting a comprehensive approach to mental health care. Methods A single-center randomized controlled trial in an outpatient psychotherapeutic clinic will examine the effects of an intensified smoking cessation intervention versus a waiting control condition. The primary outcome measures include smokers’ nicotine dependence, smoking behavior, and mental health symptoms related to their primary mental disorder, analyzed using variance analysis methods. The smoking intervention consists of a common guideline-based cognitive-behavioral program supplemented by a digital health application. Secondary outcomes include changes in self-reported self-efficacy and implicit cognitive biases. In addition, motivational measures, self-efficacy, implicit approach tendencies, and attitudes toward online interventions will be assessed as secondary measures and examined as potential predictors, moderators, or mediators in exploratory analyses. Attitudes toward online interventions will be measured once at baseline, while all other measures will be assessed before the intervention, post-treatment, and at 6-week and 6-month follow-up sessions. Discussion Addressing smoking behavior before psychotherapy holds potential to significantly enhance mental health outcomes. This study investigates the integration of smoking cessation strategies prior to psychotherapeutic care for cigarette-smoking individuals with mental disorders. By aligning tobacco dependence treatment with approaches used for other substance use disorders, we aim to establish and discuss a comprehensive and guideline-conformant method. This strategy seeks to improve patient outcomes and a cohesive, integrated method for treating smokers with comorbid mental health disorders. Trial registration Prospectively registered on ISCRTN on 01.05.2024, reference number ISRCTN12859609.

We explored the relationship between the Fagerström Test for Nicotine Dependence (FTND) and smoking abstinence rates in 10 randomized, double-blind placebo-controlled Phase 2-4 varenicline studies. Participants were adult smokers (≥10 cigarettes/day) who were motivated to quit. Efficacy end points included continuous abstinence rate (CAR) for weeks 9-24 analyzed, by baseline FTND and Heaviness of Smoking Index (HSI) scores, and treatment. Data were analyzed using logistic regression models. Overall, 2,763 varenicline (M [SD] FTND score: 5.6 [2.2]) and 2,229 placebo subjects (5.5 [2.1]) were included in the analysis. An increase of one unit in baseline FTND or HSI score decreased the odds of abstinence at Week 24 by 11% (odds ratio [OR] 0.89, 95% CI 0.86-0.92, p < .0001) and 18% (OR 0.82, 95% CI 0.79-0.87, p < .0001), respectively. Treatment had a significant impact on CAR 9-24: odds of abstinence were increased threefold for varenicline versus placebo (OR 3.3, 95% CI 2.8-3.8, p < .0001). There was no interaction between treatment and FTND (p = .98) or HSI score (p = .97) for CAR 9-24. The HSI score predicted abstinence outcome as effectively as the FTND score. Abstinence rates decreased with increasing dependence scores. There was no interaction between treatment and baseline FTND or HSI score, suggesting that they have no effect on the efficacy of varenicline versus placebo. These results also suggest that the HSI may be as effective at predicting smoking cessation outcome as the whole FTND questionnaire.

Background Smoking is a leading cause of preventable death, disproportionately affecting people with low socioeconomic status (SES) and serious psychological distress (SPD). The U.S. Food and Drug Administration (FDA) has proposed reducing nicotine levels in cigarettes and other combusted tobacco products to minimally addictive levels, a policy with significant public health potential. However, misperceptions about very low nicotine cigarettes (VLNCs), such as beliefs that they are less harmful or ineffective for quitting, may reduce policy effectiveness. While previous randomized controlled trials (RCTs) have examined the effects of using VLNCs, none have incorporated messaging to address misperceptions. This study evaluates the impact of a messaging campaign on smoking behaviors, risk perceptions, and quit intentions among people who smoke, focusing on individuals with low SES, SPD, and neither. The primary objective is to assess whether exposure to VLNC-related messages reduces the number of cigarettes smoked per day compared to VLNC use alone. Secondary objectives include examining effects on other tobacco product use, nicotine dependence, forgoing cigarettes, perceived risks, and quit intentions. Methods This multi-site, open-label, parallel-arm RCT will enroll 1230 adults who smoke ( n  = 410 per group: with SPD, low SES, neither category). After a 1-week baseline period, participants will be randomized (1:1) to receive either (1) VLNCs with messaging or (2) VLNCs only (control). Messaging will include pack inserts and digital ads shown during weekly visits to address misperceptions and encourage quitting. Participants will complete daily logs via text messages and attend weekly visits over 4 weeks for data collection, including self-reported smoking behavior, expired carbon monoxide (CO) samples, and questionnaire assessments. The primary outcome is the number of cigarettes smoked per day in the final study week (week 4). Secondary outcomes include the use of other tobacco products, nicotine dependence, forgoing cigarettes, and quit intentions. Discussion This trial will be the first to examine the effects of a messaging campaign accompanying VLNC use among priority populations. Results will inform FDA regulatory strategies and public health messaging to support nicotine reduction policy implementation. Trial registration ClinicalTrials.gov NCT06787937. Registered on 22 January 2025.

Cyanoethyl mercapturic acid (CEMA) is a urinary metabolite of acrylonitrile, a toxicant found in substantial quantities in cigarette smoke, but not in non-combusted products such as e-cigarettes or smokeless tobacco and rarely in the diet or in the general human environment. Thus, we hypothesized that CEMA is an excellent biomarker of combusted tobacco product use. We tested this hypothesis by analyzing CEMA in the urine of 1259 cigarette smokers (urinary cotinine ≥25 ng/mL) and 1191 nonsmokers. The analyses of CEMA and cotinine were performed by validated liquid chromatography-tandem mass spectrometry methods. Logistic regression was fit for log-transformed CEMA to construct the receiver operating characteristic curve. We found that a CEMA cutpoint of 27 pmol/mL urine differentiated cigarette smokers from nonsmokers with sensitivity and specificity greater than 99%. The use of different cotinine cutpoints to define smokers (10-30 ng/mL) had little effect on the results. CEMA is a highly reliable urinary biomarker to identify users of combusted tobacco products such as cigarettes as opposed to users of non-combusted products, medicinal nicotine, or nonusers of tobacco products. CEMA can be used to distinguish users of combusted tobacco products from non-combusted products such as e-cigarettes, smokeless tobacco, and medicinal nicotine. Levels of CEMA in the urine of people who use these non-combusted products are extremely low, in contrast to cotinine.

Background Electronic cigarettes have been developed and marketed in recent years as smoking substitutes. However, no studies have evaluated their effects on the cardiovascular system. The purpose of this study was to examine the immediate effects of electronic cigarette use on left ventricular (LV) function, compared to the well-documented acute adverse effects of smoking. Methods Echocardiographic examinations were performed in 36 healthy heavy smokers (SM, age 36 ± 5 years) before and after smoking 1 cigarette and in 40 electronic cigarette users (ECIG, age 35 ± 5 years) before and after using the device with “medium-strength” nicotine concentration (11 mg/ml) for 7 minutes. Mitral flow diastolic velocities (E, A), their ratio (E/A), deceleration time (DT), isovolumetric relaxation time (IVRT) and corrected-to-heart rate IVRT (IVRTc) were measured. Mitral annulus systolic (Sm), and diastolic (Em, Am) velocities were estimated. Myocardial performance index was calculated from Doppler flow (MPI) and tissue Doppler (MPIt). Longitudinal deformation measurements of global strain (GS), systolic (SRs) and diastolic (SRe, SRa) strain rate were also performed. Results Baseline measurements were similar in both groups. In SM, IVRT and IVRTc were prolonged, Em and SRe were decreased, and both MPI and MPIt were elevated after smoking. In ECIG, no differences were observed after device use. Comparing after-use measurements, ECIG had higher Em (P = 0.032) and SRe (P = 0.022), and lower IVRTc (P = 0.011), MPI (P = 0.001) and MPIt (P = 0.019). The observed differences were significant even after adjusting for changes in heart rate and blood pressure. Conclusions Although acute smoking causes a delay in myocardial relaxation, electronic cigarette use has no immediate effects. Electronic cigarettes’ role in tobacco harm reduction should be studied intensively in order to determine whether switching to electronic cigarette use may have long-term beneficial effects on smokers’ health. Trial registration Current Controlled Trials ISRCTN16974547

Rationale Individuals with depression smoke more than smokers without depression. Research has shown that cigarette demand is a useful tool for quantifying tobacco reinforcement and supposes a clinical predictor of treatment outcomes. Despite previous studies examining the relative reinforcing efficacy of nicotine among different populations of smokers, to date, no study has assessed cigarette demand among individuals with elevated depressive symptoms. Objective The aim of this study was to compare cigarette demand among samples of smokers with low and elevated depressive symptoms. Further, it also sought to examine the relationship between depressive symptomatology and the individual CPT demand indices. Methods Participants (80 non-depressed smokers and 85 depressed smokers) completed the 19-item version of the Cigarette Purchase Task (CPT). Depression symptomatology was assessed using the Beck Depression Inventory-Second Edition (BDI-II). Depressed smokers needed to present at least moderate depressive symptoms as indicated by scoring ≥ 20 on the BDI-II. Results Depressive symptomatology and nicotine dependence were significantly associated with elasticity of demand ( R 2  = 0.112; F (2, 155) = 9.756, p  = ≤ 0.001). Depressive symptoms, cigarettes per day, and years of regular smoking also predicted breakpoint scores ( R 2  = 0.088; F (4, 153) = 3.697, p  = 0.007). Conclusion As smokers with elevated depressive symptoms are less sensitive to increases in cigarette prices than those with low depressive symptomatology, future studies should consider these cigarette demand indices when designing depression-focused smoking cessation treatments. Providing this difficult-to-treat population with interventions that promote both pleasurable and alternative reinforcing activities is highly encouraged.

Background Smoking is highly prevalent among people who have experience of severe mental ill health, contributing to their poor physical health. Despite the ‘culture’ of smoking in mental health services, people with severe mental ill health often express a desire to quit smoking; however, the services currently available to aid quitting are those which are widely available to the general population and may not be suitable or effective for people with severe mental ill health. The aim of this study is to explore the effectiveness and cost-effectiveness of a bespoke smoking-cessation intervention specifically targeted at people with severe mental ill health. Methods/design SCIMITAR+ is a multicentre, pragmatic, two-arm, parallel-group, individually randomised controlled trial. We aim to recruit 400 participants aged 18 years and above with a documented diagnosis of bipolar disorder, schizophrenia or schizoaffective disorder who smoke. Potentially eligible participants identified in primary or secondary care will be screened, and baseline data collected. Eligible, consenting participants will be randomly allocated to one of two groups. In the intervention arm, the participant will be assigned a mental health professional trained to deliver smoking-cessation interventions who will work with the participant and participant’s GP or mental health specialist to provide an individually tailored smoking-cessation service. The comparator arm will be usual care – following current NICE guidelines for smoking cessation, in line with general guidance that is offered to all smokers, with no specific adaptation or enhancement in relation to severe mental ill health. The primary outcome will be self-reported smoking cessation at 12 months verified by expired carbon monoxide (CO) measurement. Secondary outcome measures include Body Mass Index at 12 months, the Fagerström Test for Nicotine Dependence, Motivation to Quit questionnaire, SF-12, PHQ-9, GAD-7, EQ-5D-5 L, and health service utilisation at 6 and 12 months. The economic evaluation at 12 months will be conducted in the form of an incremental cost-effectiveness analysis. Discussion SCIMITAR+ trial is the largest trial to our knowledge to investigate the effectiveness of a bespoke smoking-cessation service for people with severe mental ill health. Trial registration International Standard Randomised Controlled Trials Number, ISRCTN72955454 . Registered on 16 January 2015.

Background The TAPS Tool is a substance use screening and brief assessment instrument that was developed for use in primary care medical settings. It is one of the first screening instruments to provide rapid assessment of all commonly used substance classes, including illicit and prescription opioids, and is one of the only available screeners designed and validated in an electronic self-administered format (myTAPS). This secondary analysis of data from the TAPS Tool validation study describes the feasibility and acceptability of the myTAPS among primary care patients. Methods Adult patients (N = 2000) from five primary care clinics completed the TAPS Tool on a tablet computer (myTAPS), and in an interviewer-administered format. Requests for assistance and time required were tracked, and participants completed a survey on ease of use, utilization of audio guidance, and format preference. Logistic regression was used to examine outcomes in defined subpopulations, including groups that may have greater difficulty completing an electronic screener, and those that may prefer an electronic self-administered approach. Results Almost all participants (98.3%) reported that the myTAPS was easy to use. The median time to complete myTAPS screening was 4.0 min (mean 4.48, standard deviation 2.57). More time was required by participants who were older, Hispanic, Black, or reported non-medical prescription drug use, while less time was required by women. Assistance was requested by 25% of participants, and was more frequently requested by those who with lower education (OR = 2.08, 95% CI 1.62–2.67) or age > 65 years (OR = 2.79, 95% CI 1.98–3.93). Audio guidance was utilized by 18.3%, and was more frequently utilized by participants with lower education (OR = 2.01, 95% CI 1.54–2.63), age > 65 years (OR = 1.79, 95% CI 1.22–2.61), or Black race (OR = 1.30, 95% 1.01–1.68). The myTAPS format was preferred by women (OR = 1.29, 95% CI 1.00–1.66) and individuals with drug use (OR = 1.43, 95% CI 1.09–1.88), while participants with lower education preferred the interviewer-administered format (OR = 2.75, 95% CI 2.00–3.78). Conclusions Overall, myTAPS screening was feasible and well accepted by adult primary care patients. Clinics adopting electronic screening should be prepared to offer assistance to some patients, particularly those who are older or less educated, and should have the capacity to use an interviewer-administered approach when required.

The decrease in smoking rates in North America has plateaued, underscoring the need for new approaches to treat nicotine dependence. Inter-individual differences in smoking behavior result, in part, from variation in the rate of CYP2A6-mediated nicotine metabolism. A phenotypic measure of CYP2A6 activity is the nicotine metabolite ratio (NMR), the ratio of 3'hydroxycotinine/cotinine. The NMR is associated with smoking cessation. However, the NMR is also associated with genetic (eg, CYP2A6 genotype) and other (eg, sex and ethnicity) factors. Here we aimed to determine if previously identified non-CYP2A6 sources of variation in the NMR mitigated the association between the NMR and short-term abstinence. The NMR was determined from blood samples collected at intake from daily smokers aged 18-65. Biochemically-verified point prevalence abstinence (exhaled carbon monoxide level ≤ 8 ppm) was measured at 1 week following the target quit date in participants from a smoking cessation clinical trial (NCT01314001). Analyses were restricted to N = 462 blacks and N = 693 whites in the intent-to-treat sample. Lower NMR (<0.31) was associated with a higher likelihood of 1-week abstinence (OR = 1.43; 95% CI = 1.12, 1.84). NMR was associated with abstinence even after controlling for treatment arm (nicotine patch or varenicline) and factors previously associated with NMR variation including sex, ethnicity, estrogen-containing hormonal therapy, body mass index, alcohol, and cigarette consumption. NMR was associated with 1-week smoking abstinence; NMR may be a useful addition to medication screening approaches evaluating treatments for nicotine dependence.

Virtual reality (VR) has been shown to be effective in eliciting responses to nicotine cues in cigarette smokers. The primary aim of this study was to investigate whether cigarette-deprived smokers would exhibit increased craving and changes in heart rate when viewing cigarette related cues as compared to non-smoking cues in a VR environment, and the secondary aim was to assess the extent to which self-assessed measures of withdrawal and dependence correlated with VR craving. Nicotine-dependent cigarette smokers were recruited for a 2 day study. On Day 1, participants smoked as usual and on Day 2 were deprived from smoking overnight. On both days, participants completed self-assessment questionnaires on withdrawal, craving, and nicotine-dependence. Participants completed a VR session during the cigarette deprivation condition only (Day 2). During this session, they were exposed to active smoking and placebo (non-smoking) cues. The data show that self-reported levels of \"craving\" (p < .01) and \"thinking about cigarettes\" (p < .0001) were significantly greater after exposure to the active cues versus non-smoking cues. Significant increases in heart rate were found for 3 of 4 active cues when compared to non-smoking cues (p < .05). Finally, significant positive correlations were found between self-reported craving prior to the VR session and craving induced by active VR cues (p < .01). In this report, active VR cues elicited craving during cigarette deprivation. This is the first study to demonstrate that self-reported craving, withdrawal symptoms, and nicotine dependence severity predict cue-induced craving in the VR setting.