View clinical trials related to Nicotine Dependence.
Filter by:The purpose of this study is to better characterize differences in mood, attention, brain activation patterns underlying the beneficial effects of pharmacological treatments previously demonstrated to be help individuals successfully quit tobacco smoking. Smokers will be randomly assigned to one of three treatments: 1) bupropion sustained release (SR), 2) nicotine patch, or 3) placebo patches plus pills across a 45-day period with a 3-week intensive post-treatment follow-up. In addition, 20 percent of the subjects will be randomized to a delayed-quit control group.
The primary aim of this project is to test the effect of exercise on acute nicotine withdrawal. Acute nicotine withdrawal is characterized by a complex array of symptoms associated with increased risk of relapse among individuals attempting smoking cessation. The available remedies do not target all aspects of withdrawal. For example, pharmacologic treatments reduce withdrawal-based craving, but have no effect on cue-related craving, altered sleep, and mood disturbances during withdrawal. Therefore, non-pharmacologic behavioral techniques with the potential to attenuate persistent withdrawal symptoms are needed. We hypothesized that exercise can be a valid non-pharmacologic strategy to improve these domains.
The transdermal nicotine patch is the most widely used form of tobacco dependence treatment in the US and Europe, but most smokers are unable to successfully quit with this form of treatment. Failure to respond to this treatment may, to a large extent, be due to the use of nicotine patches for only 8 weeks, the recommended treatment duration. We have found in a controlled randomized clinical trial that using the nicotine patch for 24 weeks can increase quit rates significantly. We propose here a clinical trial to replicate and extend these results to a community setting in the real-world, using the same research design utilized in clinical trials to demonstrate the effectiveness of methadone maintenance therapy for opiate dependence. Specifically, 540 smokers will receive counseling and standard (8-weeks), extended (24-weeks), or maintenance (52 weeks) therapy with transdermal nicotine patches. The main outcome is biochemically-verified smoking cessation at week 52. The cost-effectiveness, safety, and mechanism of effect (e.g., promotion of recovery following a lapse) for maintenance therapy with transdermal nicotine will also be assessed. The study results may change how we treat nicotine dependence with transdermal nicotine.
Background: - Individuals who have schizophrenia are significantly more likely to smoke than the general population, which leads to increased smoking-related illnesses and high rates of nicotine dependence. Research suggests that high rates of smoking and nicotine addiction in people with schizophrenia are related to the fact that nicotine temporally improves performance in several cognitive tasks, including sensory gating, long-term memory, and visual tracking-all of which are affected by schizophrenia. - Smoking among schizophrenia patients may be a form of self-medication, since nicotine may temporarily treat and improve cognitive deficits caused by schizophrenia. Researchers are interested in studying the effects of nicotine on the brain activity of individuals with schizophrenia to better understand how nicotine affects the brain regions connected to memory, visual tracking, and attention. Objectives: - To identify specific brain regions involved in the anticipatory learning deficits found in schizophrenia patients who smoke. - To determine whether and how nicotine enhances performance in these regions. Eligibility: - Smokers (at least 10 cigarettes per day) between 18 and 50 years of age who either are healthy volunteers or have been diagnosed with schizophrenia/schizoaffective disorder. Design: - Participants will be asked to avoid consuming alcohol and restrict consuming caffeinated beverages for 24 hours before the study days. Participants will provide urine and breath samples at the start of the study to be tested for chemicals that may interfere with the study. - The study will require two to four visits, with two fMRI sessions and other visits for a clinical interview or training. Participants will have a training session with a possible mock MRI scan to learn how to do tasks that track eye movement and measure ability to pay attention. - During the fMRI scanning sessions, participants will receive either a nicotine patch or a placebo patch without nicotine. After the patch is in place, participants will perform tasks while receiving MRI scans. The scans will take up to 2 hours. - Participants will provide blood samples after finishing the MRI sessions.
Background: - Central nicotinic acetylcholine receptors (nAChRs) are the primary target for the action of nicotine. In addition to being involved in tobacco dependence, they are also involved in a variety of brain disorders, including Alzheimer's and Parkinson's diseases. Researchers are interested in developing better ways to study the action of nAChRs to improve treatments for smoking cessation and other problems affected by these receptors. These new study methods may involve different radiotracers, which are drugs that can help show brain activity during positron emission tomography (PET) scanning. Objectives: - To evaluate the feasibility of using a radiotracer, 2-[18F]F-A-85380, in PET scanning of the brain. Eligibility: - Healthy volunteers between 21 and 45 years of age who do not use tobacco. Design: - Participants will be asked to avoid consuming alcohol or using a number of over-the-counter medications, including antihistamines, cough medicines, and nasal decongestants, for 5 days before the study day. Participants provide urine and breath samples at the start of the study to be tested for chemicals that may interfere with the study. - Participants will visit the clinical center the morning of the day before the scanning session to provide blood and urine samples as required. Participants will return and be admitted for an overnight stay later that afternoon or evening. - On the day of the study, participants will receive a single dose of the radiotracer 2-[18F]F-A-85380, and will have a series of PET scans over the next 7 hours and provide blood samples during that time. Participants will spend that night at the clinical center and leave on the morning after the end of the study. - Participants will return for follow-up visits 2 weeks and 1 month after the end of the study.
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....
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.
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.
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.
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.