View clinical trials related to Smoking Cessation.
Filter by:The purpose of this study is to collect the efficacy and safety information in subjects who have been retreated with varenicline (Champix®) within 52 weeks of initial treatment for their appropriate use in daily practice and are participants for varenicline Drug Use Investigation protocol A3051109 ((NCT# NCT00772941).
The investigators propose to evaluate the relationship between PTSD, mood, craving and withdrawal symptoms and factors associated with relapse in the context of a randomized clinical smoking cessation trial. The use of supplemental nicotine administration (SNA) during a "pre-treatment" phase before a targeted quit date is an innovative development in smoking cessation, and may be helpful in treating smokers with PTSD. The use of SNA during ad lib smoking for smokers with PTSD is predicted to reduce both the physiological and emotional dependence on inhaled nicotine, thereby increasing the odds of successful smoking cessation. Smokers with PTSD will be randomly assigned to 1 of 2 pre-cessation patch therapy conditions (active patch versus placebo patch) for 2 weeks before a target quit-smoking date. All participants will receive brief cognitive-behavioral therapy (CBT) and will begin standard nicotine replacement therapy on their quit day. PTSD symptoms, mood, smoking craving and withdrawal symptoms will be evaluated using electronic diary assessment for one week prior to the pre-cessation period, during the 2-week pre-cessation period, and 6 weeks post quit date. The study is designed to address the following aims: Specific Aim 1: To examine the effects of SNA on PTSD symptoms, mood, craving and withdrawal through electronic diary assessment. Hypothesis 1.1. SNA will decrease craving for cigarettes during the 2 week pretreatment period as compared to the placebo patch condition. Hypothesis 1.2. SNA will decrease the perceived improvement in mood and PTSD symptoms associated with smoking behavior. Hypothesis 1.3. SNA during the pre-cessation period will result in a reduction of withdrawal symptoms following the quit-date. Specific Aim 2: To evaluate the effect of SNA on quit rates among smokers with PTSD. Hypothesis 2. SNA during the pre-cessation period will result in improved quit rates Specific Aim 3: To investigate potential predictors of relapse including PTSD symptom severity, mood, anxiety sensitivity, distress tolerance, and self-efficacy. Hypothesis 3.1 - 3.5 Increased PTSD symptom severity, increased baseline negative affect, increased anxiety sensitivity, decreased distress tolerance, and lower self-efficacy each will independently be associated with shorter abstinence from smoking.
The specific aim of this proposed pilot study is to compare two standardized processes (paper and electronic) to deliver a customized MedlinePlus health information prescription.
Smoking among Latino males living in the U.S. is a significant public health problem, one that can contribute to disparities in life expectancy and increase mortality. Latinos smoke at the same rate as White males but are less likely than Whites to quit. Interventions do not reach Latino smokers because many speak only Spanish and previous interventions have had notable limitations. First, most have recruited volunteers, so hard-to-reach Latino smokers likely did not participate. Second, cessation effects were short-term only. Third, no program has attempted to boost Latino cessation rates by capitalizing on a "teachable moment", a time when quitting may seem especially relevant. To address these deficits, we propose to conduct a teachable moment intervention trial for Latino smokers. We will attempt to capitalize on the potential teachable moment of Latinas' pregnancy as an impetus for Latinos' cessation. We will include couples, rather than just men, to sustain intervention effects. We will partner with community leaders to develop an intervention based primarily on Social Cognitive Theory, the Teachable Moment Model, and the Cognitive-Behavioral Couple Therapy Model. Some elements will be at the individual level to help Latinos quit smoking and others will be couple-based to improve communication and reduce stress in the postpartum relationship. The program will be culturally sensitive to Latino values, such as familismo, valuing of and duty to the family and personalismo, valuing warm personal relationships. We will recruit Latino couples (n=366) into a Guia (control) arm in which men receive a culturally appropriate smoking cessation guide, and a couple-based smoking cessation counseling arm. Hypothesis 1: Latino expectant fathers who receive couple-based counseling to quit smoking will be more likely to be abstinent from smoking at 28 weeks in pregnancy and 12 months post-randomization than Latino expectant fathers who receive a self-help smoking cessation guide. Hypothesis 2: Couple-based counseling will improve mediators, such as couple communication about smoking, self-efficacy, outcome expectancies, stress levels, risk perceptions, emotion, and self-image, which in turn, will increase cessation rates among Latino expectant fathers. Hypothesis 3: Couples in the counseling arm will have a greater increase in cessation during pregnancy and a lower decrease in cessation at 6 and 12 months post-randomization than couples in the Guia arm.
Smoking cessation is often difficult for smokers to achieve for a variety of reasons including: difficulty with nicotine withdrawal, failure to perceive the benefits of smoking cessation, and failure to perceive the risks associated with smoking. We argue that the most effective biomarkers to affect perceptions of harm, especially for lung cancer, are those that signal progression towards disease development Proposed is a pilot study of educating smokers about the role of genetics and lung cancer in Durham VA out-patient clinics. The goal of this pilot study is to assess the interest in study participation from the VA smoking population, as well as to determine the fraction of subjects who will complete the study to power a future larger trial. Interested patients will receive a 15 minute educational presentation on the function of p16 and its role in development of lung cancer. They will then be assessed for airway obstruction by hand-held spirometry followed by review of a questionnaire assessing their understanding of the presented information, their concern for developing lung cancer, and their desire to quit smoking. All patients will be offered smoking cessation assistance at this point. Enrolled patients will then be given 3 sputum cups to take home and return with morning sputum samples by mail. Samples will be assessed for evidence of p16 methylation and patients will be informed of the results. Follow-up phone interviews will be performed at 2 to 4 weeks after patients have received their results by mail to assess their understanding of the results, and their desire to stop smoking. A final phone interview will occur approximately 3 months after the sputum testing to assess attempts to stop smoking as well as the patients continued understanding of their test results. For purposes of this pilot, we are interested primarily in the descriptive statistics (e.g., frequencies) associated with the outcome of each objective (e.g., how many expressed interest, how many returned the sputum samples).
Background: - Denicotinized cigarettes are similar to commercial cigarettes but contain and deliver virtually no nicotine. Denicotinized cigarettes are used as a control condition in smoking research, as a substitute treatment for nicotine dependence, and as a strategy to reduce incidence of nicotine addiction. However, the symptoms of nicotine withdrawal and craving for cigarettes must be minimized to ensure that smokers will continue to use denicotinized cigarettes instead of their preferred cigarettes. - Although research has shown that smokers preferred cigarettes that delivered nicotine, subjective measures of tobacco craving and withdrawal were similar after standard and denicotinized cigarettes. This suggests that the process of smoking and non-nicotine components of tobacco smoke mediate some of the effects of cigarette smoking. More research is needed on the comparative physical and mental effects of regular cigarettes and denicotinized cigarettes. Objectives: - To compare the effects of complete abstinence or smoking denicotinized cigarettes with smoking nicotinized cigarettes on the following measures: (1) withdrawal symptoms and quality of sleep, (2) hormonal responses, (3) mood and cognitive performance, and (4) functional brain activity. Eligibility: - Men between 18 and 50 years of age who are either current smokers (at least 15 cigarettes per day for at least 2 years) or nonsmoking volunteers. Design: - Participants will be divided into four groups: (1) nonsmokers, (2) smokers who receive nicotinized cigarettes, (3) smokers who receive denicotinized cigarettes, and (4) smokers who will abstain from cigarettes. - The study will last 16 days. Smokers will have 14 visits to the clinical center; nonsmokers will have 6 visits. From Day 6 to Day 14, current smokers will follow the smoking regimen assigned by the researchers (not smoking, smoking denicotinized cigarettes, or smoking nicotinized cigarettes). - Nonsmokers will have one day of training on the memory and thinking tasks that will be performed in the functional magnetic resonance imaging (fMRI) scanner, and will have 5 additional days of two fMRI scans per day (total of 10 fMRI scans). - Current smokers will have 2 days of training on the memory and thinking tasks that will be performed in the fMRI scanner, physical assessments on Day 3 and Day 6, and 5 days of two fMRI scans per day (total of 10 fMRI scans). - Participants in the complete abstinence group will be asked to resume smoking after the abstinence period and the denicotinized cigarettes group will resume nicotinized cigarettes on day 14. Participants can decline to resume smoking, and if desired they will be referred for smoking cessation treatment.
The purpose of this study is to test whether it is feasible to provide a smoking cessation program together with a yoga program to help women quit smoking. We anticipate that women will be enthusiastic about the program and that we will be able to recruit and treat women for smoking cessation within the designated time frame.
Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.
Bupropion and varenicline are indicated for smoking cessation. The objectives of this study are two-fold: (1) to explore the logistic feasibility of distributing bupropion and varenicline free of charge to treatment-seeking smokers in the province of Ontario, Canada and (2) to evaluate the real-world effectiveness of bupropion and varenicline treatment in Ontario compared to a no-drug comparison group. In an open label study, Ontario smokers who smoke 10 or more cigarettes per day and intend to quit smoking in the next 30 days, will enroll via the study website, visit their physician to receive a prescription for bupropion or varenicline for 12 weeks or neither if they so choose, forming the no-drug comparison group. All participants will receive weekly motivational emails for 12 weeks. Abstinence measures will be taken at 4, 8 and 12 weeks and at 6 and 12 months. The proportion of eligible participants who were able to confirm an appointment with a physician to receive the prescription will be also measured.
This study will evaluate the single-dose pharmacokinetics, safety, and tolerability of a varenicline patch applied to the skin.