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Nicotine Dependence clinical trials

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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: 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.

NCT ID: NCT01412866 Completed - Schizophrenia Clinical Trials

Electronic Decision Support Systems for Smokers With Severe Mental Illness

Start date: May 2011
Phase: N/A
Study type: Interventional

This randomized clinical trial among SMI smokers assessed whether the EDSS with carbon monoxide monitor and health-checklist feedback lead to higher rates of initiation of smoking cessation treatment, days of smoking abstinence and Fagerstrom Dependence scores, compared to use of the EDSS with checklist feedback alone.

NCT ID: NCT01406223 Completed - Nicotine Dependence Clinical Trials

Mechanistic Evaluations of Pre-Cessation Therapies for Smoking Cessation

ConNicBrain
Start date: July 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to look at brain function in order to understand how different treatments work to help people quit smoking. In this study, the investigators will look at the effects of nicotine patches, Chantix alone or Chantix paired with Zyban.

NCT ID: NCT01393392 Completed - Nicotine Dependence Clinical Trials

Developing a Smoking Cessation Intervention for Methadone Maintained Smokers

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

The purpose of this study is to pilot and evaluate, in a randomized controlled trial, the immediate and long-term effects of a newly developed, tailored, intensive smoking cessation intervention among methadone maintained smokers and compared to a control condition (facilitated referral to the NJ Quitline). The newly developed intervention is evidence based, addresses the unique needs of methadone maintained smokers, is intensive, can be tailored to the individual, and builds on the strengths as well as addresses the gaps in previous treatments for methadone maintained smokers. The investigators hypothesize that: (1) three months and six months after beginning treatment, those in the tailored intervention condition will be more likely to be abstinent from smoking than those in the control intervention condition (primary outcome); (2) there will be a greater relapse rate in the control intervention condition between the three and six month follow-up points than in the tailored intervention condition; (3) three and six months after beginning treatment, those in the tailored intervention condition will have better secondary smoking related outcomes (smoked fewer cigarettes per day in the past week, be more ready to quit, have greater self-efficacy for quitting, experience less nicotine dependence, and be more likely to have made a quit attempt) than those in the control intervention condition; (4) three and six months after beginning treatment, those in the tailored intervention condition will have better utilization of and adherence to smoking cessation pharmacotherapy, better mental and physical health, less perceived stress, greater social support, less drug and alcohol use, and greater involvement in drug and alcohol treatment than those in the control intervention condition; and (5) the newly created tailored intervention will be feasible and acceptable. .

NCT ID: NCT01393301 Completed - HIV Clinical Trials

Integrated Treatment for Smoking Cessation & Anxiety in People With HIV

Project Quit
Start date: October 2011
Phase: N/A
Study type: Interventional

During the 1-year formative phase of a study to develop an integrated treatment for quitting smoking for anxiety-vulnerable HIV+ smokers. During this first phase of the study, start-up activities will include piloting the integrated treatment on a small group of individuals (N = up to 12), obtaining expert consultant and participant feedback, and development of the final treatment manual and procedures. The goal during this phase will be to establish feasibility of treatment delivery, participant acceptability, and potential for a treatment effect before conducting a pilot randomized trial of the treatment. During the two-year pilot RCT phase of the above study, we directly develop and test a novel psychosocial/behavioral and pharmacological smoking cessation intervention for HIV+ smokers with interfering psychological distress.

NCT ID: NCT01368653 Completed - Nicotine Dependence Clinical Trials

Evaluation of Learning-Theory-Based Smoking Cessation Strategies

Start date: June 2012
Phase: N/A
Study type: Interventional

This clinical trial tested whether a new treatment designed to help smokers prepare to quit smoking by practicing quitting several times helped more smokers quit and stay quit than standard treatment with nicotine patch and smoking cessation counseling. The practice quitting treatment tested involved quitting for progressively longer periods of time tailored to individual patterns of smoking. This clinical trial also tested whether non-nicotine cigarettes can help smokers become smoke free after slipping during a stop smoking attempt.