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Tobacco Use Disorder clinical trials

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NCT ID: NCT01037153 Completed - Nicotine Dependence Clinical Trials

Effects of Nicotine on Brain Activity as Measured by fMRI

Start date: August 6, 2002
Phase: N/A
Study type: Observational

Background: - Nicotine addiction is common among people who smoke tobacco, and the addictive properties of nicotine make smoking cessation difficult even for people who want to quit. Research has shown that smoking causes changes in the brain that lead to addiction and craving, but more research is needed to determine how different doses of nicotine and different intervals of receiving nicotine affect brain function. A greater understanding of nicotine's effect on the brain, as studied through functional magnetic resonance imaging (fMRI), may improve the effectiveness of smoking cessation therapies and treatments. Objectives: - To determine the effects of nicotine on brain function and chemistry in experienced cigarette smokers. Eligibility: - Current smokers (at least 20 cigarettes per day for at least 1 year) between 18 and 50 years of age. Design: - The study involves five separate research experiments. Most participants will be involved in only one experiment. - The experiments will evaluate brain activity and function using fMRI. Participants will be trained in a series of tests on cognitive function before beginning the experimental part of the study. - Experiment 1: Participants will have three fMRI scan sessions after receiving different dose levels of intravenous nicotine. - Experiment 2: Participants will have four fMRI scan sessions after receiving two doses of nicotine separated by 1/4, 1/2, 3, and 24 hours. - Experiment 3: Participants will have two sets of nicotine injections separated by 45 minutes, with each injection series containing five rapid injections of small amounts of nicotine (to mimic five puffs on a cigarette). - Experiment 4: Participants will have three fMRI sessions after receiving a single injection of nicotine at three different rates (over 15, 60, or 120 seconds). In addition there will be three more sessions involving a nicotine patch and a nicotine injection as well as a placebo session. - Experiment 5: Participants will have three fMRI sessions that will involve looking at different kinds of pictures related to or not related to smoking after receiving a single injection of nicotine. - Participants will also provide blood samples for further study....

NCT ID: NCT01036711 Completed - Nicotine Dependence Clinical Trials

Effects of Nicotine on Cognitive Task Performance and Brain Activity as Measured by fMRI

Start date: September 17, 2002
Phase:
Study type: Observational

Background: - Many cigarette smokers claim that smoking improves their ability to think and concentrate, and have reported problems in thinking and concentration after quitting smoking. Some research has indicated that nicotine can enhance certain aspects of attention and memory in humans. However, more research is needed to determine how nicotine affects different elements of the brain s ability to think, pay attention, respond to rewards, and make decisions. Researchers are interested in using functional magnetic resonance imaging (fMRI) to study the effects of nicotine on brain function and activity. Objectives: - To determine the effects of nicotine on attentional and other thinking processes, including reward-seeking behavior. Eligibility: - Individuals between 18 and 50 years of age who are either current smokers (10 or more cigarettes per day for at least 1 year) or nonsmokers. Design: - The study has four experiments. Each experiment requires two MRI scanning sessions and a training session. Participant can do one or all of the experiments. - Participants will receive training on the types of computerized tests that will be given during the active portion of the study. Participants will also fill out questionnaires on nicotine use and other alcohol and drug use, and provide breath and urine samples. - During the test sessions, participants will have fMRI scanning while performing up to four different sets of tasks that test attention, memory, concentration, reward-seeking behavior, and decision making. Smokers will wear a nicotine patch or placebo patch during the test sessions, but will not be told which patch they are receiving. The order of these sessions will be different for individual participants. - Participants will provide blood and urine samples throughout the research study for evaluation purposes.

NCT ID: NCT01034085 Completed - Schizophrenia Clinical Trials

Effects of Nicotine on Areas of Impaired and Preserved Functioning in Schizophrenia

Start date: June 2, 2009
Phase:
Study type: Observational

Background: - Some people with schizophrenia have problems with their working memory and paying attention for extended periods. These difficulties cannot be treated with antipsychotic medications or with many standard therapies. - The prevalence of cigarette smoking among individuals with schizophrenia is about three times higher than in the general population. Research has shown that nicotine, the addictive component found in cigarettes, can help improve attentional and working memory performance. Researchers are interested in learning more about whether there may be an overlap in the cognitive functions beneficially affected by nicotine and areas of dysfunction in individuals with schizophrenia. Objectives: - To evaluate the potential of transdermal nicotine to alleviate cognitive deficits in schizophrenia, and to determine whether naturally maintained cigarette-smoking, in comparison, is an effective self-medication. - To gather preliminary data on genetics that may account for individual and group differences in the performance effects of nicotine. Eligibility: - Current smokers (25 or more cigarettes per week for at least 1 year) between 18 and 55 years of age who are either healthy volunteers or have been diagnosed with schizophrenia/schizoaffective disorder. Design: - The study will require five visits to the research center, with an initial screening visit, a training session, and three test sessions. Ideally, all visits will occur 1 week apart. - Training session: Participants will receive training on the types of computerized cognitive and attentional behavior tests that will be given during the active portion of the study. Participants will also fill out questionnaires on nicotine use and other alcohol and drug use. - Test sessions: Participants will be assigned to random groups and will complete tests that assess cognitive performance (a) while maintaining their usual smoking behavior, (b) after minimal deprivation (3.5 hours without smoking) while wearing a placebo patch, and (c) under the influence of a standard nicotine patch. The order of these sessions will be different for individual participants. - Participants will provide blood samples throughout the research study for evaluation purposes.

NCT ID: NCT01034020 Completed - Nicotine Dependence Clinical Trials

Effects of Nicotine on Elements of Attentions in Smokers and Nonsmokers

Start date: February 14, 2006
Phase: Phase 1
Study type: Interventional

Background: - Many cigarette smokers claim that smoking helps them stay alert and improves their concentration, and have reported problems in attention and concentration after quitting smoking. Some research has indicated that nicotine can enhance certain aspects of attention and memory in humans. However, more research is needed to determine how nicotine affects different elements of the brain's ability to pay attention. Knowing which aspects of attention are affected by nicotine may help produce new medications and therapies to help people successfully stop smoking. Objectives: - To investigate the dose-related effects of nicotine on the ability to pay attention in smokers and nonsmokers. - To compare the effects of nicotine in smokers and nonsmokers. Eligibility: - Individuals between 18 and 50 years of age who are either current smokers (at least 15 cigarettes per day on average for at least 2 years) or healthy, nonsmoking volunteers. Design: - The study will consist of one training session and three testing sessions. Each session will last about 2 hours. - The training session will introduce participants to the study tests and evaluate their tolerance of the two levels of nicotine nasal spray used in the study. Smokers will receive the higher dose of nicotine to introduce them to the effects of the spray. Nonsmokers will be given first the lower dose of the spray, followed by higher dose at least 30 minutes later. Nonsmoking participants who cannot tolerate the higher dose will not continue in the study. - At the start of each testing session, smokers will have one cigarette to standardize the time of the most recent exposure to nicotine. - During the testing sessions, participants will receive a placebo spray, a lower dose of nicotine, or a higher dose of nicotine, and then will be asked to perform tests that evaluate mood, attention, and performance.

NCT ID: NCT01031693 Completed - Nicotine Dependence Clinical Trials

Pilot Study of Transcranial Magnetic Stimulation (TMS) in Nicotine Addiction

Start date: July 13, 2009
Phase: Phase 1
Study type: Interventional

Background: - Treatment for nicotine addiction is characterized by high rates of relapse. New treatment therapies for nicotine addiction are exploring the use of brain scanning equipment to control and decrease nicotine and cigarette cravings. - Transcranial magnetic stimulation (TMS) uses magnetic pulses to stimulate the brain. These pulses can change activity in parts of the brain. Researchers are interested in determining whether TMS delivered in single pulses can decrease activity in the parts of the brain that respond to nicotine craving. Objectives: - To determine whether single pulse TMS can reduce cue-induced nicotine craving and use in cigarette smokers. Eligibility: - Individuals 18 years of age and older who are physically healthy and have smoked 10 or more cigarettes per day for at least 1 year. - A small group of healthy nonsmoking control subjects 18 years of age and older will also participate in the study. Design: - The study will involve seven study visits and two follow-up visits. The control participants will have only two visits: one with a magnetic resonance imaging (MRI) scan and one with TMS to evaluate brain function and response. - Participants will have an initial assessment about tobacco use habits and craving patterns, and will provide blood and urine samples before beginning the study. - Participants will have two initial MRI brain scans. The first scan will look at the structure of the brain at rest. During the other scan, participants will look at images related to and not related to cigarette smoking. - The single pulse TMS sessions (with either actual TMS or inactive [sham] TMS) will be held daily for 5 consecutive days. Magnetic pulses will be triggered by cigarette-related picture cues and delivered at varying intervals before the participant sees a cigarette-related picture. During these testing visits, researchers will ask questions related to tobacco use and craving, and collect urine and breath samples for further study. - Participants will have two follow-up visits, 1 week and 2 weeks after the TMS sessions, to evaluate memory and mood, and will have one final MRI brain scan at the end of the study.

NCT ID: NCT01031433 Completed - Nicotine Dependence Clinical Trials

Assessment of Craving in Nicotine-Dependent Patients With Schizophrenia Using Virtual Reality

Start date: July 28, 2009
Phase:
Study type: Observational

Background: - The prevalence of cigarette smoking among individuals with schizophrenia is noticeably higher than in the general population, and smoking cessation attempts frequently are unsuccessful in this population. Little is known about the effects of cigarette/nicotine craving in individuals with schizophrenia. Researchers are interested in learning more about how craving affects people with schizophrenia and developing new ways to treat cravings and improve the effectiveness of smoking cessation therapies and treatments. - In recent years, virtual reality (VR) has been studied to determine whether it can be used to induce craving by using life-like cue settings. VR cues involving cigarette use, including images of cigarettes and scent cues of tobacco smoke, may be used to elicit craving in smokers. Researchers are interested in learning more about how individuals with schizophrenia respond to specific VR cues and settings. Objectives: - To determine the feasibility of using a contextual real-world paradigm using virtual reality involving cigarette smoking in people with schizophrenia. - To examine if virtual reality cues will elicit craving in smokers with schizophrenia. Eligibility: - Current smokers (five or more cigarettes per day for at least 1 year) between 18 and 45 years of age who have been diagnosed with schizophrenia/schizoaffective disorder. Design: - The study will involve three sessions, with an initial screening visit, a test session, and a follow-up session. - Screening visit: Participants will be screened with a medical and psychiatric history, and will answer questions about smoking history, current smoking habits and craving patterns, and general anxiety levels. This session will also introduce participants to the operation and use of the VR equipment. Participants who are comfortable using the VR system will return within 2 days for the test session. - Test session: Participants will use the VR equipment to view neutral scenes and scenes that are designed to elicit cravings for cigarettes. After viewing each scene, participants will answer questions about their overall mood, anxiety levels, and any cigarette cravings they may have. - Follow-up session: Participants will return 1 week after the VR session to answer questions about mood, anxiety levels, and current smoking habits and craving patterns.

NCT ID: NCT01031121 Completed - Nicotine Dependence Clinical Trials

Breath Carbon Monoxide and Cotinine as Biomarkers to Distinguish Smokers From Nonsmokers

Start date: June 8, 2009
Phase: N/A
Study type: Observational

Background: - Self-report and biochemical verification are used to determine smoking status in treatment trials and clinical research. Each method has merits and limitations that make it appropriate for particular situations. Participants who feel social pressure to report tobacco abstinence may provide unreliable self-reporting results. Biochemical verification using breath carbon monoxide (CO) is a more reliable indicator, but several biological and environmental factors (including exposure to secondhand smoke) can affect the sensitivity and specificity of breath CO measurement. - An ideal biomarker of smoking status is cotinine, the major metabolite of nicotine. Cotinine levels found in blood, urine, and saliva can be used to distinguish between smokers and nonsmokers, as well as between light and heavy smokers. Researchers are interested in using cotinine assessments to develop suitable breath CO cutoff levels to categorize different types of smokers and nonsmokers for use in future research. Objectives: - To determine a breath carbon monoxide (CO) cutoff level that optimally discriminates between heavy and light smokers and nonsmokers who are and who are not exposed to environmental tobacco smoke. Eligibility: - Individuals between 18 and 64 years of age who fall into one of the following groups: - current smokers reporting more than 10 cigarettes per day for at least 6 months - current smokers reporting 10 or fewer cigarettes per day for at least 6 months - nonsmokers reporting regular environmental exposure to tobacco smoke - nonsmokers reporting limited or no exposure to tobacco smoke Design: - The study will involve a single outpatient session. - Participants will provide breath CO, urine, and saliva samples, and will complete several smoking-related questionnaires on smoking history, current craving levels, and perceived level of nicotine dependence.

NCT ID: NCT01023659 Completed - Smoking Cessation Clinical Trials

Distribution of Bupropion and Varenicline to Increase Smoking Cessation Attempts

Start date: April 2010
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT01021215 Completed - Clinical trials for Tobacco Use Disorder

Zileuton With or Without Celecoxib As Chemopreventive Agents in Smokers

Start date: May 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical research study is to learn how zileuton alone or the combination of zileuton and celecoxib may affect certain chemicals in the body that may be linked with a risk for smoking-related lung disease. These effects will be measured by a urine test

NCT ID: NCT01018394 Completed - Tobacco Dependence Clinical Trials

Nicotine Lozenge or Tobacco-Free Snuff for Smokeless Tobacco Reduction

Start date: January 2009
Phase: Phase 2/Phase 3
Study type: Interventional

Smokeless tobacco (ST) is a known human carcinogen. Long-term ST use is known to increase the risk for oropharyngeal cancer. Extant literature on cigarette smokers suggests that smoking reduction increases smoking abstinence among smokers not interested in quitting. The overarching goal of this line of research is to develop a ST reduction intervention among ST users not interested in quitting tobacco. Our first step is to conduct the proposed pilot study designed to assess the efficacy of the nicotine lozenges or tobacco-free snuff for reducing ST use or facilitating ST abstinence among ST users not interested in quitting.