Active clinical trials for "Tobacco Use Disorder"

Using a 2x2 randomized factorial design, we will conduct a statewide field trial in Missouri to compare the relative and combined effects of these two strategies for augmenting an existing, evidence-based tobacco quitline program. Among 2000 low-income smokers, half will receive standard Missouri quitline services and half will receive new Specialized Quitline services targeted to this group. In each of these groups, half also will receive calls from a trained navigator to help them address unmet Basic Needs and the accompanying psychological distress that act as barriers to smoking cessation.

The objective of the study is to determine the effect of non-invasive brain stimulation on craving for tobacco and brain metabolites.

Tobacco smoking is a major health problem, leading to considerable morbidity and mortality due to cancer, impaired pulmonary function, and cardiovascular diseases. Chronic nicotine consumption related to smoking may affect pulmonary function and can cause neuronal alterations leading to increased emotional distress and decreased cognitive functioning, especially when the smoker attempts to quit. These may explain the huge difficulty in quitting and the dependence on cigarettes as a means of maintaining emotional balance. The possibility that reduced sleep quality is a major negative outcome that contributes to nicotine addiction has been largely overlooked. Several studies have shown that smoking and smoking cessation disrupt sleep quality; however, the vast majority of these studies were based on subjective reports. Moreover, it is not clear to what degree disrupted sleep quality among smokers may be related to reduced pulmonary function, and to what degree reduced sleep quality contributes to the emotional cognitive distress of active and abstinent smokers and to their urge to smoke. The main hypothesis of this proposal is that smoking and early phases of smoking cessation will be associated with reduced sleep quality. This poor sleep quality will be associated with emotional and cognitive symptoms and difficulty in abstaining from tobacco smoking. Successful abstinence from smoking over time will lead to normalization of the quality of sleep. Experiments to investigate this hypothesis will be conducted on healthy young adults addressing the following specific aims: 1) To examine physiological and psychological factors predicting reduced quality of sleep among smokers, including: poor pulmonary function, the degree of nicotine dependence, altered regulation of stress systems (HPA axis and the sympathetic nervous system), and emotional distress (anxiety and depression); 2) To explore the impact of smoking cessation on sleep quality and related symptoms. Specifically, whether smoking cessation induces fragmented sleep and poor sleep quality, and whether the diminished sleep quality can predict the magnitude of emotional and cognitive symptoms; 3) To examine whether poor sleep (before and during abstinence) can predict the level of the urge to smoke and smoking relapse among abstinent smokers; 4) To explore whether sleep quality ultimately improves following prolonged abstinence from smoking. Addressing these aims, nonsmokers and smokers will be examined before and during smoking abstinence on the following measures: quality of sleep via actigraphy and polysomnography (PSG), pulmonary function test, biological markers of stress (cortisol and α-amylase) and smoking (i.e., cotinine, the main metabolite of nicotine), and emotional and cognitive functioning via psychometric tests. Results of this study will provide novel insight on the role of sleep in nicotine addiction. Experiments will show how reduced quality of sleep may result from chronic smoking and interfere with attempts to quit smoking. Also, the experiment will shed light on the interrelated physiological and psychological mechanisms that mediate the interplay between smoking addiction and sleep. The research will utilize a variety of powerful methods and an interdisciplinary collaboration of experts in the fields of sleep, addiction, and pulmonary medicine. It is anticipated that the results will contribute substantially to our knowledge of smoking addiction and may promote the development of effective therapeutic interventions to this major public health problem.

Tobacco smoking continues to be the primary cause of preventable mortality in the United States. Despite the availability of smoking cessation aids, the majority of those trying to quit smoking end up relapsing. Thus, there is a strong need to evaluate alternative treatment targets such as orexin antagonists, which have shown promise in preclinical models at reducing the motivational aspects of drug use.The current work will evaluate the influence of orexin antagonism on several factors impacting the motivation to smoke.

The primary aim of this study is to conduct a 60-patient feasibility, acceptability, and preliminary efficacy study of mSMART (Mobile App based Personalized Solutions and Tools for Medication Adherence of Rx Pill), a smartphone application ("app") for improving medication adherence among substance users. The investigators will compare 2 groups of cigarette smokers undergoing a quit attempt with varenicline (Chantix): a) an experimental group using the mSMART app on their smartphone and a MEMS Cap (Medication Event Monitoring System, a smart pillbox that will a record a date and time-stamped medication event whenever pill box is opened and closed, and thus allow for primary measurement of medication adherence) and b) a control group using the MEMS Cap and mobile web-based surveys on their smartphone.

The purpose of this study is to determine whether electronic cigarettes can reduce reactivity to smoking-related cues.

Electronic Nicotine Delivery Systems (ENDS), commonly referred to as electronic cigarettes have gained in popularity over the last several years. The technology used to manufacture ENDS has been evolving rapidly with a variety of delivery mechanisms, nicotine content, e-liquids and flavorings. Only in the last few years have researchers begun to examine the health risks and benefits, nicotine blood levels, patterns of use, likability, and craving and withdrawal relief of ENDS. These studies have shown great variability in nicotine delivery, effects on heart rate, and relief of craving or withdrawal among various ENDS brands among tobacco cigarette smokers. This study will test a new generation ENDS, the NJOY King Bold (NJOY, Scottsdale, AZ). It is a single use unit that resembles a traditional cigarette and delivers approximately 150 puffs. The cartridge inside contains 26 milligrams of nicotine. Our primary objective is to evaluate the short-term effects of using the NJOY Kings ENDS on heart rate, carbon monoxide and blood nicotine levels and well as on craving for cigarettes and nicotine withdrawal. Our secondary objective is to evaluate the subject's usage patterns for cigarettes and NJOY King ENDS during a one-week period in which they can use each freely. The study includes three visits to the clinic spaced approximately one week apart. Subjects who pass the screening visit will return to the clinic for Visit 2 in which they will sample the NJOY King ENDS for about 20 minutes before taking home enough to last till Visit 3, one week later. They will be instructed to use as many or as few as they like during the week. Subjects will keep a daily diary of number of tobacco cigarettes smoked and number of e-cigarette puffs taken. Subjects will return to the clinic for Visit 3 after 12 hours of abstinence from any form of nicotine in order to assure that they have no nicotine left in their bloodstream. Eligible subjects will then participate in two series of 10 puffs of NJOY Kings spaced one hour apart. During the 2.5 hours of the testing day, the following will be measured: 1) heart rate, 2) carbon monoxide, 3)blood will be sampled for nicotine levels, 4) craving for cigarettes and nicotine withdrawal symptoms will be assessed.

Primary care physicians can play an important role in reducing tobacco smoking in the population. The general practice is a suitable setting for implementing proactive smoking interventions, because a large proportion of the population can be regularly reached in a favorable psychological state. Further, a trustful interpersonal relationship between the practitioners and their patients is supposed to increase the susceptibility to preventive measures. However, currently general practitioners are not capitalizing this advantage although evidence based treatments are available, which are effective and cost-effective. Outreach programs combining educational and practice-based measures have been found to be effective in engaging practitioners in screening and in giving advice. Computer expert-system and brief counseling interventions, which are based on the Transtheo-retical Model of behavior change (TTM), are promising approaches for the entire population of practitioners and smoking patients. For large scale implementation, data are needed about the degree of integration in every day routine clinical practice that could be achieved by implementing such interventions. Objectives: Evaluating different strategies for the implementation of proactive smoking interventions in general practices. Methods: In a randomized controlled trial, 150 randomly selected general practices of a defined German region will be included. The procedure comprises the implementation of 1) an on-site computer expert-system intervention, 2) a counseling intervention provided by the practitioner, or 3) the computer expert-system plus the counseling intervention. During an implementation phase of one month, two on site training sessions and support by phone will be provided. Routine use of the interventions will be monitored for the following 6 months. Main outcome measures are the number and rate of identified and treated smokers. A follow-up assessment will be realized 12 months after practice attendance to determine the smoking status of the treated smokers.

The investigators want to find out if providing a Community Health Educator Referral Liaison (CHERL) helps practices help their patients change risky behaviors (tobacco use, physical inactivity, unhealthy diet, and risky drinking) by connecting patients to available services in the community or directly providing behavior change support.

Objectives. To evaluate the effectiveness and cost effectiveness of clinical practice guide based intervention with two face-to-face visits and e-mail tracking compared to brief advice to obtain continued smoking abstinence at 6 and 12 months after intervention. Methodology. simple randomized controlled multicentric trial. All smokers (N=1064) aged 18 or older that attend by any reason to the primary care center and that have an e-mail account and they checked it at least once a week will be invited to participate. The enrolled participants will be randomly divided into control (N=532) and intervention group (N=532). An intensive intervention, based on the recommendations of the clinical practice guides, that will include six contacts (2 face-to-face and 4 by e-mail) will be applied to the intervention group. Control group will receive brief advice. The main dependent variable will be continued abstinence of tobacco consumption at six and twelve months after the beginning of the intervention which will be validated by and a carbon monoxide breathe analysis measured by a cooximeter in standard conditions. Secondary variables will include: stage change on the quitting smoking process and evaluation of the effectiveness on the reduction of the number of smoked cigarettes at six and twelve months after intervention. A descriptive analysis of all variables will be done. A multivariate analysis will be undertaken to assess differences among intervention and control group; logistic regression for dichotomic variables and lineal regression for continuous variables.