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Nicotine Dependence clinical trials

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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: NCT00996034 Completed - Nicotine Dependence Clinical Trials

Nicotine Vaccination and Nicotinic Receptor Occupancy

Start date: September 2009
Phase: Phase 2
Study type: Interventional

This is a molecular imaging research study designed to examine how much nicotine gets into the brain before and after vaccination with NicVAX, a nicotine vaccine developed by Nabi Biopharmaceuticals. NicVAX (Nicotine Conjugate Vaccine) is an investigational vaccine designed as an aid to smoking cessation and long-term abstinence, as well as an aid to prevent relapses of a treated smoker. In this project we want to understand the degree to which NicVAX administration changes how much nicotine enters the brain in smokers.

NCT ID: NCT00969137 Completed - Nicotine Dependence Clinical Trials

Sensitivity to Intravenous Nicotine: Genetic Moderators

Start date: June 2, 2009
Phase: Phase 1
Study type: Interventional

To determine if the mu opioid receptor gene (OPRM1) A118G polymorphism moderates the subjective-rewarding effects of intravenous (IV) nicotine in male and female smokers. The subjective effects of nicotine will be measured with a Drug Effects Questionnaire, including the ratings of "good effects" and "drug liking". We hypothesize that smokers with the AG/GG genotype for the OPRM1 A118G will have attenuated subjective-rewarding effects from IV nicotine when compared to those with AA genotype.

NCT ID: NCT00960778 Completed - Nicotine Dependence Clinical Trials

Gender Differences in Response to Nicotine Replacement Therapy and De-Nicotinized Cigarettes

BIRCWH
Start date: March 2009
Phase: Phase 2
Study type: Interventional

This study will investigate the underlying neurobiology of differences between male and female smokers. Research suggests that women are less responsive to nicotine replacement therapy (NRT) than men and more responsive to the sensory and behavioral aspects of smoking. This study proposed that male smokers will have a greater response to NRT demonstrated by reduced withdrawal symptoms, craving, and less blood-oxygen-level dependent functional magnetic resonance imaging (BOLD FMRI) regional brain activation in response to nicotine-cues as compared to female smokers treated with NRT. Additionally, female smokers will have a greater response to denicotinized cigarettes with decreased withdrawal symptoms, craving, and less BOLD fMRI activation in response to nicotine-cues as compared to male smokers.

NCT ID: NCT00956943 Completed - Nicotine Dependence Clinical Trials

Assessment of High Dose Transdermal Nicotine for Fast Metabolizers of Nicotine

HDP
Start date: August 2009
Phase: Phase 2
Study type: Interventional

Unfortunately, the investigators still need to assess and identify novel ways to help people quit smoking. Differences between people in terms of how fast they metabolize nicotine influences response to transdermal nicotine patches, the most popular nicotine dependence treatment, and it affects plasma levels of nicotine from treatment. These studies suggest that fast metabolizers of nicotine may show better quit rates if they receive higher doses of transdermal nicotine. This preliminary study is designed to assess, for the first time, whether fast nicotine metabolizers show higher quit rates if given high dose transdermal nicotine, versus standard dose. The study findings may help to support a subsequent large trial to assess standard versus high dose transdermal nicotine for slow versus fast metabolizers of nicotine, which may lead to a more personalized approach to treating nicotine dependence using the nicotine patch to improve therapeutic benefits of transdermal nicotine.

NCT ID: NCT00948649 Completed - Nicotine Dependence Clinical Trials

Effects of Chantix on Relapse Prevention for Smoking Cessation

Start date: September 2006
Phase: Phase 4
Study type: Interventional

The goal of the proposed study is to validate an experimental paradigm to assess medication effects on smoking relapse following a brief (3-day) monitored period of smoking abstinence and a programmed cigarette lapse.

NCT ID: NCT00948155 Completed - Nicotine Dependence Clinical Trials

Measuring Smoking Behaviors While Using Varenicline

Start date: January 2009
Phase: Phase 4
Study type: Interventional

This study will demonstrate the behavioral responses to varenicline, helping to better understand its mechanisms. Hypotheses for the study are to observe decreases in smoking topography and nicotine cigarette choice on varenicline, relative to placebo; and decreases on day 21 relative to day 7 during varenicline treatment. We also propose to examine if extended duration of treatment has clinical significance in decreasing smoking behaviors, thus increasing the efficacy of varenicline.

NCT ID: NCT00937235 Completed - Nicotine Dependence Clinical Trials

Treatment of Smoking Among Individuals With PTSD

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

This study will examine the effect of combining prolonged exposure, a cognitive-behavioral treatment program for post-traumatic stress disorder (PTSD) with medication (varenicline) and counseling treatments for smoking cessation. Subjects will be randomly assigned to a 3-month treatment of either: 1) varenicline and smoking cessation counseling alone, or 2) prolonged exposure, varenicline, and smoking cessation counseling. Assessments will be completed at the end of treatment and 6-month follow-up. We hypothesize that, at the end of treatment and at follow-up, abstinence rates and decrease in cigarettes smoked will be greater among participants who receive the combined treatment for both PTSD and smoking.

NCT ID: NCT00936299 Completed - Clinical trials for Attention Deficit Hyperactivity Disorder

Bupropion for ADHD in Adolescents With Substance Use Disorder

Start date: January 2009
Phase: Phase 4
Study type: Interventional

Attention deficit hyperactivity disorder (ADHD) is one of the most common co-occurring psychiatric disorders (30-50%) in adolescents with substance use disorders (SUD). Yet, little is known about the safety and efficacy of medications for ADHD in adolescents with SUD, since such youths have been excluded from most medication trials. Clinicians are therefore understandably reluctant to treat ADHD in substance abusing adolescents, often first referring such youths to substance treatment. Untreated ADHD is associated with poorer substance treatment outcomes. We address this research gap by proposing a randomized controlled trial of bupropion vs placebo in 130 adolescents (13-19 years) with Diagnostic and Statistical Manual (DSM IV) ADHD, nicotine dependence and cannabis use disorder (not excluding other SUD). Participants in both bupropion and placebo treatment groups will receive weekly individual manualized-standardized cognitive behavioral therapy (CBT) targeting SUD (at no cost to them) throughout the 16 weeks of the medication trial. Bupropion also is effective in treating nicotine dependence in adults; the majority of adolescents with marijuana and other drug abuse also smoke tobacco. More recent research in adults indicates that bupropion may reduce craving and use of other substances of abuse (e.g. methamphetamine, cocaine). It's possible impact on cannabis use disorder (the addiction for which most teens are referred to treatment) has not yet been evaluated. However since all drugs of abuse have a final common pathway leading to addiction via action in the so called brain reward system (ventral tegmental area (VTA), accumbens) -an important secondary aim is to evaluate bupropion's potential impact on craving and use of marijuana (MJ) in addition to its known similar action on nicotine.