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Tobacco Dependence clinical trials

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NCT ID: NCT00973622 Completed - Tobacco Dependence Clinical Trials

Changing Thought and Action in Tobacco Dependence With Transcranial Magnetic Stimulation

rTMS
Start date: October 2009
Phase: N/A
Study type: Interventional

This study will examine the effects of high frequency, repetitive Transcranial Magnetic Stimulation (rTMS) on decision-making and smoking behavior.

NCT ID: NCT00968513 Active, not recruiting - Tobacco Dependence Clinical Trials

Evaluation of Tobacco Treatment Strategies for Inpatient Psychiatry

Start date: September 2009
Phase: Phase 3
Study type: Interventional

This study aims to evaluate, in a randomized controlled trial, tobacco treatments of varying intensities for smokers hospitalized on acute psychiatric inpatient units.

NCT ID: NCT00918307 Completed - HIV Infections Clinical Trials

Efficacy and Safety of Varenicline Among HIV-infected Patients

Inter-ACTIV
Start date: October 2009
Phase: Phase 3
Study type: Interventional

Cigarette smoking is a major cause of illness among HIV-infected patients (non-AIDS defining malignancies (especially lung cancer), non-AIDS bacterial infections and cardio-vascular diseases). Approximately 50% of HIV-infected patients are regular tobacco smokers. Tobacco smoking cessation has well known benefits on mortality and morbidity in the general population where tobacco cessation assistance programs are increasingly implemented. However, smoking cessation interventions have never been evaluated among HIV-infected patients. This trial aims at evaluating the efficacy and safety of varenicline for smoking cessation compared with placebo.

NCT ID: NCT00873535 Completed - Alcohol Dependence Clinical Trials

Effect of Varenicline on Reactivity to Smoking and Drinking Cues

Start date: October 2008
Phase: N/A
Study type: Interventional

Alcohol and nicotine dependence are often co-morbid, with 85% of alcoholics also smoking. However, very little research has been conducted into the nature of this co-occurrence. Thus, the main aim of this study is to assess differences in alcohol and tobacco consumption and cue-induced craving in treatment-seeking smokers after two weeks treatment of varenicline. Hypotheses 1. Two weeks of varenicline treatment will significantly decrease cue-induced tobacco craving compared to placebo (Due to the actions of varenicline on alpha-4-beta-2 receptors and its downstream effect on dopamine release). 2. Varenicline will decrease cue-induced alcohol craving compared to placebo. 3. The impact of Varenicline on cue-induced alcohol craving will be greater in heavy drinkers compared to social drinkers.

NCT ID: NCT00789074 Completed - Smoking Cessation Clinical Trials

Use of Varenicline for 4-weeks Prior to Quitting

Start date: July 2009
Phase: Phase 3
Study type: Interventional

Varenicline (Champix) is a relatively new medicine that is effective in helping people to quit smoking. It is normally started 1-week before stopping smoking and used for up to 12-24 weeks. We are trying to find out if using varenicline for an extended time (4-weeks) before stopping smoking is better than the standard 1-week of use prior to stopping. The study will recruit 100 smokers who want to stop. They will be randomly allocated to receive varenicline(4−weeks) or placebo (3−weeks followed by 1−week of active treatment as indicated by standard prescribing practice), followed by a 12−week open label treatment period where all participants will receive varenicline.

NCT ID: NCT00777569 Completed - Tobacco Dependence Clinical Trials

Comparisons of Nicotine-free Cigarettes, Extra Low Nicotine Cigarettes vs. Medicinal Nicotine

Start date: March 2005
Phase: Phase 2
Study type: Interventional

In this study, smokers will be randomly assigned to one of three conditions for six weeks: 1) nicotine-free cigarettes (0.05mg); 2) extra low nicotine cigarettes (0.3 mg); or 3) medicinal 4 mg nicotine lozenge. The tobacco toxin profiles across these various products will be compared. The effects of these products on biomarkers of exposure and risk factors for disease, compensatory smoking, components of tobacco addiction and short-term smoking cessation will be determined. Predictors of response to these products (e.g., compensatory smoking, compliance with product use, time to lapse) will also be examined. The following primary hypothesis will be tested: 1) Extent of tobacco toxin exposure will be greatest for the extra low nicotine cigarette and least for nicotine lozenge. Other secondary hypotheses include: 2) Compensatory smoking, as calculated by using cotinine, will be greatest for the extra low cigarette compared to the nicotine-free cigarette; 3) Greater positive subjective responses to cigarettes will be observed with extra low nicotine vs. nicotine-free cigarette; 4) Similar withdrawal symptoms and negative affect will be observed with nicotine-free cigarette and nicotine lozenge, and least withdrawal and negative affect with the extra low nicotine cigarette; 6) Least dependence and greatest motivation and self-efficacy to quit will be observed with nicotine lozenge and the greatest dependence and least motivation and self-efficacy to quit with the extra low nicotine cigarette use; 7) Shorter time to lapse will be observed with extra low nicotine vs. nicotine-free cigarettes because of extinction is likely to occur with nicotine-free cigarettes, and the longest time to lapse for nicotine lozenge because the cigarette condition groups will have experienced stronger attentional bias toward cues, and more dependence prior to the quit date and greater withdrawal after the quit date.

NCT ID: NCT00755716 Completed - Tobacco Dependence Clinical Trials

Topiramate Alone and in Combination With the Nicotine Patch for Smoking Cessation: A Pilot Study

Start date: April 2006
Phase: Phase 3
Study type: Interventional

Specific aims: 1. To obtain pilot data on 4-week continuous quit rates associated with 10 weeks of treatment with topiramate or placebo or topiramate plus nicotine patch for smoking cessation. 2. To obtain pilot data on the effects of 10 weeks of topiramate versus placebo versus combination of topiramate plus nicotine patch on nicotine withdrawal symptoms, smoking satisfaction, and adverse effects during smoking cessation. 3. To obtain pilot data on weight gain over 10 weeks with topiramate versus placebo versus combination of topiramate plus nicotine patch for smoking cessation.

NCT ID: NCT00749463 Completed - Tobacco Dependence Clinical Trials

Evaluation of the Safety Profile, Quit and Reduction Rate After Nicorette® Gum and Patch Treatment

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

To evaluate the safety, smoking cessation and reduction rate during 3 months of active nicotine replacement therapy (NRT) and a follow-up period of 3 months in smoking hospital physicians and staff who are motivated to quit

NCT ID: NCT00747643 Completed - Tobacco Dependence Clinical Trials

Varenicline Effects on Cue Reactivity and Smoking Reward/Reinforcement

Start date: September 2008
Phase: N/A
Study type: Interventional

The purpose of this study was to find out how varenicline works to help people quit smoking. Varenicline, also known as Chantix™, is an U.S. Food and Drug Administration (FDA) approved medication that has been shown to help people quit smoking. This study was trying to evaluate whether varenicline would change the response to smoking and the desire for cigarettes when compared to an inactive placebo control. This was not a quit smoking treatment study, and participants were not asked or required to stop smoking while in this study.

NCT ID: NCT00722124 Completed - Tobacco Dependence Clinical Trials

S-Adenosyl-L-Methionine (SAMe) for Smoking Abstinence

Start date: September 2008
Phase: Phase 2/Phase 3
Study type: Interventional

Cigarette smoking is of great public health importance and is the single most important preventable cause of morbidity, mortality and excess health care costs in the United States. After a steady decline for the last 50 years, the prevalence of tobacco use in the United States has reached a plateau of approximately 21%. Currently available treatments among adults are not efficacious for all tobacco users. New pharmacologic agents thus need to be continually developed and tested. The release of dopamine in the nucleus accumbens is one of the key components of the pleasurable and rewarding effects of nicotine. Drugs that increase monoamine neurotransmitter availability (particularly dopamine and norepinephrine) are likely to increase the reward function and thus ameliorate withdrawal symptoms. S-Adenosyl-L-Methionine (SAMe), the primary methyl donor for the central nervous system (CNS), donates methyl groups towards presynaptic synthesis of CNS monoamine neurotransmitters. By facilitating the synthesis of dopamine and norepinephrine in the brain, SAMe is likely to ameliorate the symptoms of nicotine withdrawal, thus improving tobacco abstinence rates in smokers who are trying to stop smoking. SAMe is well tolerated and is available over-the-counter. To date, no prospective clinical trial evaluating the efficacy of SAMe for the treatment of tobacco dependence has been published. We propose to evaluate the efficacy of SAMe for increasing smoking abstinence and decreasing nicotine withdrawal symptoms in a randomized, blinded, placebo-controlled, three-arm, parallel-group, dose-ranging phase II clinical trial. Participants (N=120) will be randomly assigned to one of the three groups, and will receive an 8-week course of SAMe 800-mg per day, 1600-mg per day, or a matching placebo. This study is anticipated to provide the data needed to develop a larger randomized controlled clinical trial submitted through the R01 funding mechanism, if the results appear promising.