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Nicotine Dependence clinical trials

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NCT ID: NCT01303861 Completed - Nicotine Dependence Clinical Trials

Concurrent Bupropion / Varenicline for Smoking Cessation

ConNic4
Start date: March 2011
Phase: Phase 3
Study type: Interventional

This study focuses on the first step in developing an algorithm for maximizing quit-smoking success based on an adaptive approach, which changes treatment from the initial nicotine replacement therapy (NRT) when that treatment alone may not be sufficient. These NRT "non-responders" are switched (in double-blind fashion) before the quit date to receive either varenicline alone or varenicline paired with bupropion. Some participants who would otherwise have failed at their quit smoking attempt could be "rescued" by switching to alternative pharmacotherapies. The proposed study will evaluate the combination treatment against varenicline alone in an adaptive trial design

NCT ID: NCT01299909 Completed - Nicotine Dependence Clinical Trials

Study Two on the Effectiveness of Mindfulness Training for Smokers

MTS2
Start date: March 2011
Phase: N/A
Study type: Interventional

The MTS2 study enrollment goal is N=240 adult smokers randomized to study treatments. The study design includes two randomized arms to compare matched intensive interventions and a third non-randomized option for participants who prefer not to enter an intensive intervention. It is expected that roughly 50% (120) will choose to be in the randomized intensive interventions and 50% (120) will choose to be in the non-intensive intervention. Participants who choose to be in an intensive intervention will be randomized to either Mindfulness Training for Smokers(MTS) (n = 60) or Integrated Training for Smokers (ITS)(n=60). Both MTS and ITS are smoking cessation interventions that provide 8 classes over a 6-week period and 2 weeks of nicotine patches. MTS provides and training in mindfulness whereas ITS provides training in quit smoking strategies and access to the Freedom From Smoking Online Premium Program. Participants who choose to be in a non-intensive intervention (estimated from prior recruitment data at n=120) will receive a phone-based intervention through the Wisconsin Tobacco Quit Line and 2 weeks of nicotine patches.

NCT ID: NCT01292642 Completed - Nicotine Dependence Clinical Trials

Cognitive Behavioral Therapy and the Nicotine Transdermal Patch for Cannabis Dependence and Nicotine Dependence

CBT-MJ-NIC
Start date: August 2009
Phase: Phase 2
Study type: Interventional

The investigators are conducting a Stage 1 pilot feasibility study at McLean Hospital to develop and refine a Cognitive Behavioral Therapy (CBT) intervention. The investigators aim to develop a feasible 10-week integrated CBT intervention for the treatment of concurrent marijuana dependence and nicotine dependence. The investigators hypothesize that the CBT intervention, in conjunction with Nicotine Replacement Therapy (NRT) in the form of a transdermal nicotine patch, will reduce the use of marijuana and nicotine.

NCT ID: NCT01280968 Completed - Nicotine Dependence Clinical Trials

Improving the Efficacy of Anti-Nicotine Immunotherapy

PETNic002
Start date: December 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out how vaccine-induced antibodies change the way the body processes nicotine from cigarettes. These antibodies absorb nicotine and can reduce nicotine levels in the brain. In this way, the vaccination may help to quit smoking. The central hypothesis is that anti-nicotine antibodies change kinetics of brain nicotine accumulation and distribution of nicotine between the brain and other body tissues. This vaccine is investigational which means that it is still being tested in research studies and is not approved by the U.S. Food and Drug Administration (FDA) to help people quit smoking.

NCT ID: NCT01277887 Completed - Insomnia Clinical Trials

Smoking Cessation for Smokers With Sleep Problems

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

This is a pilot research study examining two types of behavioral counseling along with the nicotine patch for smoking cessation. The study is designed to find out whether one of these counseling interventions is more effective for smoking cessation among individuals with sleep problems. The study has three parts: 1) an intake session; 2) a 10-week treatment phase, and 3) a 1-month follow-up.

NCT ID: NCT01240616 Completed - Nicotine Dependence Clinical Trials

Nicotinic Modulation of the Default Network of Resting Brain Function

Start date: October 24, 2010
Phase:
Study type: Observational

Background: - A brain circuit called the default network is the brain circuit that is active when the brain is at rest; that is, when individuals are not concentrating on specific tasks. Previous research has shown that the default network functions differently in people with schizophrenia and Alzheimer s disease, and may contribute to the problems with memory and concentration that can affect people who have these conditions. Studies have also shown that nicotine affects the default network, but more research is needed on the ways in which nicotinic receptors may change activity in these regions and thereby affect individuals ability to concentrate on specific tasks. Objectives: - To determine whether and how nicotine and mecamylamine, a drug that blocks nicotinic receptors, affect the default network in nonsmokers in ways that improve thinking and concentration. Eligibility: - Healthy, right-handed volunteers between 21 and 50 years of age. - Volunteers must not have used any kind of tobacco product in the past 2 years. Design: - This study involves an initial screening visit, a training visit, and three testing visits. - Participants will be screened with a medical history and physical examination, as well as blood and urine samples and questions about smoking history. - Participants will have an initial training session to practice the tasks that will be done during magnetic resonance imaging scans at the testing visits. These tasks will test participants concentration and memory. - Participants will have three test sessions with the following combinations of study drugs: (1) a nicotine patch and a placebo capsule, (2) a placebo patch and a capsule of mecamylamine, or (3) a placebo patch and capsule. Different combinations will be given at each visit, and participants will not know which one they receive. - Participants will perform the same concentration and memory tasks at each testing visit, and will provide a blood sample after each visit to determine levels of nicotine and mecamylamine.

NCT ID: NCT01228994 Terminated - Nicotine Dependence Clinical Trials

Baclofen for Smoking Cessation in a Non-Psychiatric Population

Baclofen
Start date: October 2010
Phase: Phase 2
Study type: Interventional

The primary hypothesis for this study is that, in nicotine-dependent tobacco smokers, baclofen will be superior to placebo for smoking abstinence measures. The secondary hypothesis is that subjects assigned to the baclofen groups will exhibit higher rates of medication compliance (i.e. take the medication as directed for the trial period) than those in the placebo group. The tertiary hypothesis is that baclofen will lead to significant reductions in tobacco withdrawal and craving ratings as compared to placebo.

NCT ID: NCT01204723 Completed - Nicotine Dependence Clinical Trials

Medications Development for the Treatment of Cannabis Related Disorders

MTC
Start date: August 2009
Phase: Phase 1
Study type: Interventional

The primary objective of this application is to test the neurobehavioral mechanisms and effects of aprepitant as a new cessation agent for cannabis, tobacco or both.

NCT ID: NCT01202955 Completed - Nicotine Dependence Clinical Trials

Pilot Study of Tolcapone in Smokers

Start date: July 2008
Phase: Phase 2
Study type: Interventional

The goals of this within-subject pilot study are: (1) assess the feasibility and safety of administering the Catechol-O-Methyl-Transferase (COMT) inhibitor, tolcapone, to smokers, and (2) explore whether tolcapone may reduce abstinence-induced cognitive and affective symptoms that promote relapse. A secondary exploratory goal is to assess whether these effects may be more pronounced in smokers who carry a high risk COMT genotype for smoking relapse: COMT val/val.

NCT ID: NCT01195597 Completed - Smoking Cessation Clinical Trials

Smoking Cessation and Reduction With an Electronic Nicotine Delivery Device (ENDD)

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

The study's major aim is to investigate the ability of a commercial Electronic Nicotine Delivery Device (ENDD) to induce long-term smoking reduction/abstinence in smokers unwilling to quit. Secondary aims are to monitor adverse events and measure participants' perception and acceptance of the product. This pilot study will evaluate smoking reduction/abstinence effects, product preferences, and adverse events of a currently marketed device in Italy ("Categoria" electronic cigarette - "ORIGINAL" 7.2 mg nicotine cartridges). The primary hypothesis is that the E-Cigarette is a safe device that allows smoking reduction or abstinence in smokers.