Treating Schizophrenic Smokers: Effects on Craving, Cues and Withdrawal
Tobacco Use DisorderThis is a clinical research protocol to study the efficacy of combined varenicline (Chantix) and motivational interviewing (MI) for smoking cessation in a sample of smokers who have been diagnosed with schizophrenia or schizoaffective disorder. The study is a double-blind, randomized, controlled, subacute treatment trial of MI plus varenicline (VAR-MI) versus MI plus placebo (PLA-MI). The pharmaceutical treatment will utilize Chantix at a dose of 1 mg/day for a period of two weeks. The primary goal is to determine if VAR-MI decreases baseline behavioral measures of urge and withdrawal and reduces baseline rates of cigarette consumption. The primary efficacy measures of VAR-MI vs. PLA-MI treatment are: Minnesota Nicotine Withdrawal Scale, Questionnaire for Smoking Urge-brief, number of cigarettes smoked per day in the previous week, CO levels, and Brief Psychiatric Rating Scale and Positive And Negative Symptom Scale scores on the last day of the study. Other primary outcome measures are to determine the effects of VAR-MI and PLA-MI on smoking cue-induced urges in tobacco cue reactivity sessions and reward responsiveness as assessed by a computerized task.
p16 Methylation for Smoking Cessation
Tobacco Use DisorderSmoking Cessation1 moreSmoking 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).
Quitline Use in Surgical Patients
Tobacco DependenceElective surgery represents a teachable moment to deliver tobacco interventions. The overall goal of this proposal is to increase the utilization of the QUITPLANSM Helpline by surgical patients who smoke. Two specific aims will be pursued using a multidisciplinary research team. In the first aim, we will develop a practice-based intervention to promote QUITPLANSM Helpline utilization by surgical patients (Specific Aim 1A) using a combination of key informant interviews (approximately 30 subjects), and focus groups (approximately 25 subjects) then develop methods to educate providers in its implementation (Specific Aim 1B) and test their effectiveness in approximately 20 providers. In the second aim, we will perform a randomized clinical trial of this intervention in 300 patients scheduled for elective surgery, with the primary outcome being utilization of the QUITPLANSM Helpline (Specific Aim 2). Subjects will be randomized to receive either the intervention developed in Specific Aim 1, or a brief control intervention.
Green Tea Extract in Preventing Cancer in Former and Current Heavy Smokers With Abnormal Sputum...
Lung CancerTobacco Use DisorderRATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. Green tea extract may keep cancer from forming. PURPOSE: This randomized phase II trial is studying green tea extract in preventing cancer in former and current heavy smokers with abnormal sputum.
Effectiveness of GW468816, an NMDA Glycine Site Antagonist, for Prevention of Relapse to Smoking...
Nicotine DependenceThe purpose of this study is to evaluate the efficacy of the glycine antagonist, GW468816, compared with placebo on duration of abstinence and rates of relapse in recently quit female smokers in a randomized, double-blind, five-week clinical trial. According to the investigators, the new medication, GW468816, is thought to send certain signals in the brain that may be effective in helping people stay abstinent after they have recently quit smoking. GW468816 is a non-nicotine drug. The investigators of this study hypothesize that subjects receiving GW468816 will demonstrate a significantly longer time to relapse to smoking than those in the placebo group, as measured by the primary outcome measure (see below).
Financial Incentives for Smoking Cessation
Tobacco Use DisorderThe purpose of this study is to test the effectiveness of financial incentives for increasing long-term smoking cessation rates among employees at General Electric worksites throughout the United States.
Smoking-cessation: A Spanish-Language Clinical Trial
Smoking CessationTobacco DependenceThe purpose of this study is to develop and test a series of culturally relevant and appropriate booklets in Spanish, designed to assist Hispanic smokers in quitting smoking and remaining smoke-free.
Aspirin and Zileuton and Biomarker Expression in Nasal Tissue of Current Smokers
Tobacco Use DisorderThis randomized phase II trial studies the effects of aspirin and zileuton on genes related to tobacco use in current smokers. Aspirin and zileuton may interfere with genes related to tobacco use and may be useful in preventing lung cancer in current smokers.
Effect of Black Raspberry Phytochemicals on Oral Microbiome in Current Smokers and Non-smokers
Healthy SubjectTobacco Use DisorderThis randomized clinical trial studies the effects of black raspberry compounds (phytochemicals) on the bacteria in the mouth (oral microbiome) of current smokers and non-smokers. The oral microbiome protects the body from pathogenic bacteria. Smoking alters the oral microbiome and may increase the susceptibility to cancer by modulating normal host-bacteria interactions. Black raspberry phytochemicals may protect the oral microbiome of smokers and may lower their risk of developing oral cancer.
A Dietary Supplement for Early Cigarette Withdrawal
Nicotine DependenceCigarettes1 moreThe purpose of this study is to determine whether a dietary supplement (DS) is effective in protecting against sad mood during early cigarette withdrawal. This study will also assess whether the dietary supplement will be well tolerated during early cigarette withdrawal.