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Nicotine Dependence clinical trials

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NCT ID: NCT01557556 Withdrawn - Nicotine Dependence Clinical Trials

Pexacerfont to Reduce Stress-induced Tobacco Craving

Start date: February 24, 2012
Phase:
Study type: Observational

Background: - Stressful situations often cause tobacco cravings. These cravings can make it very difficult for smokers who are trying to quit. Research has shown that craving may involve hormone pathways in the brain. The anti-anxiety drug pexacerfont acts on these hormone pathways. Researchers want to see if pexacerfont can act on the brain and lessen stress-related tobacco cravings in smokers who are trying to quit. Objectives: - To test the effects of pexacerfont on tobacco craving in smokers who want to quit smoking. Eligibility: - Smokers between 18 to 55 years of age who are trying to quit. (Participants must have smoked at least 10 cigarettes per day for at least 1 year.) Design: - Participants will be screened with a physical exam and medical history. - Participants will be assigned to take either pexacerfont or a placebo. They will take three pills every morning for the first 7 days, then one pill every morning for 23 days. - At the first visit, participants will provide blood and urine samples. They will then be asked to prepare a 5-minute speech and give it to the study researchers. They will also be asked to do mental math problems for another 5 minutes. During these tests, blood pressure, heart rate, sweating, and skin temperature will be measured. Participants will fill out questionnaires about stress levels, tobacco cravings, and personal experiences. - Participants will take the study pills for 30 days. Before the 2-week point, participants will be asked to try to quit smoking for 2 weeks. - Participants will have four study visits. These visits will involve brain imaging scans and emotional stress tests. Tobacco cravings and other stress levels will be measured at each study. Blood and urine samples may be collected at these studies. - Participants will have follow-up visits and phone calls for up to 6 months after the end of the study visits.

NCT ID: NCT01554436 Completed - Smoking Cessation Clinical Trials

Neuropsychological Prognosis Factors of Smoking Cessation

Start date: December 2008
Phase: Phase 4
Study type: Interventional

The low overall effectiveness of available smoking cessation treatment so far, indicate the need for new and more efficacious ways to help smokers maintain abstinence. Smokers are a highly heterogeneous population. Identification of individual characteristics that predict success in smoking cessation is highly desirable to allow designing more specific strategies in order to enhance success in quitting tobacco.The main objective of this study is to assess whether the presence of certain neuropsychological deficits found before the initiation of smoking cessation is associated with a greater relapse rate.The secondary objectives concern how neuropsychological performance are involved in motivation and craving in the whole sample of smokers or in subsample. Long-term perspective is to define clinical or neuropsychological factors associated with agood or poor prognosis for success and provived more specific and therefore more effective care.

NCT ID: NCT01553084 Completed - Smoking Cessation Clinical Trials

A Comparative Effectiveness & Long Term Health Study in Wisconsin Smokers

NHLBI-RO1
Start date: May 2012
Phase: Phase 4
Study type: Interventional

The overall purpose of this research is two-fold. First, the two smoking cessation medication treatments with the strongest evidence of effectiveness have never been directly compared. This research will determine how these two treatments compare in effectiveness in a head-to-head trial, and which types of smokers benefit most from each. Second, much of the data on smoking and health come from studies from many years ago. Today's smokers differ from earlier smokers in many ways that could influence the impact of smoking on health (e.g., weight, sex, diet, socio-economic status); the proposed work will determine how smoking cessation affects cardiovascular and pulmonary health in today's smokers.

NCT ID: NCT01550029 Active, not recruiting - Bipolar Disorder Clinical Trials

Targeted Intervention for Bipolar Smokers

Start date: July 2010
Phase: N/A
Study type: Interventional

The purpose of this research is to develop and test a new type of smoking cessation counseling for individuals with bipolar disorder.

NCT ID: NCT01524627 Completed - Nicotine Dependence Clinical Trials

Effects of Varenicline on Smoking Reminders

VSMK
Start date: December 2011
Phase: Phase 2
Study type: Interventional

Varenicline is the best smoking cessation agent to date; however it is only effective in a subgroup of smokers and is associated with undesirable side effects in other subgroups. To understand the underlying pharmaco-heterogeneity, the proposed project will use perfusion functional magnetic resonance imaging and a functional candidate gene association approach using brain, behavioral, and clinical endpoints in a placebo-controlled study of chronic varenicline administration in smokers. Brain and behavioral responses to smoking cues will be will be significantly greater in 9/10-repeats compared to 10/10-repeats. DAT 9/10-repeat smokers receiving varenicline will have better treatment outcome compared to 10/10-repeats. For the purposes of the clinical trial portion of the study, the change from cigarettes per day at Baseline to the last day of treatment will be reported.

NCT ID: NCT01511614 Completed - Nicotine Dependence Clinical Trials

Nicotine Withdrawal Symptoms and Smoking Relapse

Start date: May 20, 2013
Phase: N/A
Study type: Interventional

Background: - Smoking is thought to cause changes in the brain that lead to addiction and craving. Smokers who try to quit experience nicotine withdrawal symptoms that include irritability, anxiety, and difficulty concentrating. These symptoms make it difficult for people to stop smoking. Many people say that they continue smoking to help relieve these symptoms, often within the first week after trying to quit. Researchers want to study what is happening in the brain to cause these symptoms, which may help identify new ways to successfully quit smoking. Objectives: - To study nicotine withdrawal symptoms and brain function in smokers who stop smoking for 36 hours. Eligibility: - Individuals between 18 and 65 years of age who smoke at least 10 cigarettes per day. Participants must be able to stop smoking for 36 hours on two occasions. Design: Phase 1 - This study will involve three visits to the National Institute on Drug Abuse. - NOT be able to smoke for 36 hours before the two imaging visits. - Wear a nicotine skin patch or a placebo (fake) patch during your 36 hour smoking abstinence period and study visits. - Have your blood drawn to test for levels of stress-related hormones. - Complete multiple MRI scanning sessions that last about 1.5 to 2 hours each. - Undergo EEG (brain waves) recording. - Answer questionnaires about how you think and feel. - Complete various tasks and procedures inside and outside of the MRI scanner. Phase 2 - This study will involve thirteen visits to the National Institute on Drug Abuse. - Set a quit date and develop a treatment plan with a study therapist. - Take Chantix (varenicline) every day for a period of 12 weeks. - Meet for weekly and biweekly counseling sessions with a therapist. - Answer questionnaires about how you think and feel. Phase 3 - This study will involve three visits to the National Institute on Drug Abuse. - Complete an MRI scanning session that will last about 20min each visit - Meet with a study staff member on each visit who will ask you questions about your smoking behavior and how you think and feel.

NCT ID: NCT01509547 Completed - Nicotine Dependence Clinical Trials

Varenicline for Adolescent Smoking Cessation

Start date: August 2012
Phase: Phase 3
Study type: Interventional

This is a placebo-controlled smoking cessation treatment study for adolescents ages 14-21. After assessment and inclusion into the study, participants will be randomized to receive a 12-week double blind course of varenicline or placebo.

NCT ID: NCT01505725 Completed - Nicotine Dependence Clinical Trials

Nicotine Reinforcement and Smoking-Cue Reactivity: Association With Genetic Polymorphisms

Start date: March 16, 2010
Phase:
Study type: Observational

Background: - Researchers have been studying behavioral components of nicotine addiction by looking at how drugs have a reinforcing effect, connecting the stimulation provided by the drug (nicotine) to the behavior that produces it (smoking). Based on previous studies, researchers are interested in learning more about how nicotine affects current smokers' responses to psychological tests and smoking-related cues, and in studying whether certain kinds of genetic background may affect smokers' responses to these kinds of studies. Objectives: - To compare the effect of nicotine versus denicotinized cigarettes during specific psychological tests. - To compare the effects of smoking cues versus neutral cues on craving, mood, and autonomic response. - To study the effect of genes on nicotine reinforcement and smoking-cue reactivity. Eligibility: - Individuals between 18 and 64 years of age who are current smokers (at least 10 cigarettes per day for at least 1 year) and are not currently interested in reducing their smoking or seeking treatment for tobacco dependence. Design: - Pilot session: - Participants will practice smoking using the measuring equipment that will be used in the study. - After successful practice, participants will read or listen to music for 1 hour, during which they are not allowed to smoke. - After the 1-hour period, participants will sample study cigarettes that have different levels of nicotine, and will be asked to guess whether the cigarettes are normal study cigarettes or denicotinized cigarettes. - Baseline session: - Blood, urine, and breath samples will be taken at the start of the session. - Participants will smoke part of an initial cigarette, and then will read or listen to music for 1 hour, during which they are not allowed to smoke. - After the 1-hour period, participants will give another breath sample and will complete questionnaires about mood and concentration levels. - Trial sessions: - Participants will smoke study cigarettes, and will be asked to either respond to questions about perceived nicotine levels in the cigarettes or press a lever for the chance to be rewarded with additional puffs of the cigarette. After the session, participants will give another breath sample and will complete questionnaires about mood and concentration levels. - Participants will also participate in cue-reactivity sessions to test the body's physiological response to smoking cues (a pack of cigarettes) and neutral cues (a pack of unsharpened pencils). After the session, participants will complete questionnaires on mood and concentration 15, 30, 45, and 60 minutes after the session. - At the conclusion of the last experimental session, participants will discuss the study with researchers, and may receive a referral list of smoking treatment programs.

NCT ID: NCT01480232 Terminated - Smoking Cessation Clinical Trials

A Safety and Cognitive Function Study of EVP-6124 Versus Placebo in Subjects With Nicotine Dependence

Start date: December 2011
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the initial evidence for efficacy of the investigational medicine, EVP-6124, to improve smoking cessation outcomes with and without a standard taper of nicotine replacement therapy (NRT) in healthy nicotine dependent smokers

NCT ID: NCT01422239 Completed - Nicotine Dependence Clinical Trials

A Smoking Cessation Treatment for Adult Women

Start date: January 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to develop and pilot test a smoking cessation counseling that focuses on the perceived risks of quitting smoking (e.g., weight gain, managing cravings and negative affect, loss of enjoyment). Aim 1: To develop the risk-based smoking cessation intervention. Aim 2: To examine whether manualized smoking cessation counseling about the perceived risks of quitting is feasible to administer and acceptable to adult women who want to quit smoking. Aim 3: To examine smoking cessation outcomes for women who receive the risk-based treatment in comparison to standard smoking counseling. It is expected that women who receive risk-based counseling will show better quit rates and a longer time to relapse than women who receive standard treatment.