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Smoking Cessation clinical trials

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NCT ID: NCT01476202 Completed - Smoking Cessation Clinical Trials

Provoked Craving Relief Study by NRT

NRT
Start date: November 2011
Phase: Phase 2
Study type: Interventional

This study is designed to assess the ability of the mint nicotine mouth strip to relieve provoked cigarette craving in light smokers compared to nicotine lozenge and nicotine gum.

NCT ID: NCT01474265 Completed - Smoking Cessation Clinical Trials

Sympathovagal Balance in Smoking Cessation

Start date: November 2011
Phase: Phase 4
Study type: Interventional

This study has the following primary aim: - the main objective of this study is to investigate the effects of smoking cessation during quit attempts on sympathovagal balance. These effects will be observed in smokers quitting smoking with pharmacological support or without. Secondary aims of this study are also: - the definition of MSNA in smokers and non-smokers - the investigation of other parameters concerning the autonomic nervous system, like baroreflex-sensitivity, heart rate-variability before and during the quit attempt. - the definition of withdrawal symptoms and craving before, during and after the quit attempt. - the investigation of effects of smoking cues on craving and sympathovagal balance - the investigation of relapse rates after smoking cessation in correlation with the parameters mentioned above.

NCT ID: NCT01466361 Completed - Smoking Cessation Clinical Trials

Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving

Start date: September 2010
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the ability of a nicotine lozenge to relieve craving for a cigarette compared to a matched placebo (a placebo is like sugar pill and contains no active).

NCT ID: NCT01456936 Completed - Smoking Cessation Clinical Trials

Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders

EAGLES
Start date: November 2011
Phase: Phase 4
Study type: Interventional

This study is being conducted to assess varenicline and bupropion as aids to smoking cessation treatment in subjects with and without an established diagnosis of major psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified adverse events (AEs) in both of these populations).

NCT ID: NCT01443858 Completed - Smoking Cessation Clinical Trials

Meclizine as a Potential Smoking Cessation Treatment

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

The purpose of this study is to evaluate whether meclizine, an antihistamine used to prevent or treat motion sickness, can help smokers quit smoking. This study will also investigate the potential relationship between genes you have inherited and success in quitting smoking.

NCT ID: NCT01413516 Completed - Smoking Cessation Clinical Trials

Varenicline In-Patient Study

VIP
Start date: August 2011
Phase: Phase 2
Study type: Interventional

This Investigator Initiated Research Award (IIR Award #WS981308) is a two-part pilot study that aims to examine acceptability and feasibility of varenicline use during an acute (72-hr) smoke-free hospitalization (Part 1) and 4-weeks post-hospitalization (Part 2).

NCT ID: NCT01400815 Completed - Smoking Cessation Clinical Trials

Randomized Trial to Evaluate the Effectiveness of X-22 as a Smoking Cessation Aid

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

A randomized, active controlled clinical trial in which a total of 216 healthy smokers will be enrolled and followed over approximately 19 weeks. The trial will evaluate the efficacy and safety of using X-22 as a smoking cessation aid. Healthy smokers who plan to quit smoking will be screened for eligibility. Subjects will be randomized in a 1:1 ratio to 1 of the 2 treatment arms: - Group 1: X-22 Cigarettes (very low nicotine) - Group 2: Active Control Cigarettes The randomization will be stratified by gender. Efficacy will be assessed by analysis of cigarette consumption using self-report diaries and measurement of exhaled carbon monoxide (CO) and cotinine concentrations. Safety will be assessed by evaluation of adverse events, physical examinations, clinical laboratory tests, and measurement of heart rate, blood pressure, and body weight at each study visit.

NCT ID: NCT01399866 Completed - Smoking Cessation Clinical Trials

Cognitive Remediation With D-Cycloserine

Start date: May 2011
Phase: Phase 3
Study type: Interventional

One hundred seventy-five eligible participants will be enrolled with aim of randomizing 60 to a double-blind, placebo-controlled trial of D-cycloserine added to cue-exposure treatment to prevent relapse to smoking. Subjects who sign an informed consent, meet inclusion criteria, and demonstrate response to cue reactivity at the screening visit, will either be: - started on approximately 3 weeks of either nicotine replacement therapy (NRT) at a dose of either 14 or 21 mg/day or varenicline titrated to 1.0 mg bid; decision of which method to use to quit smoking will be based on participant choice as well as taking into account any medical contraindications to either therapy. - evaluated to confirm abstinence from smoking. Recently abstinent participants referred by a smoking cessation clinic, PCP or self referred must have an expired air CO < 10 ppm to confirm abstinence. Subjects who are able to demonstrate 18-24 hours of abstinence prior to the first Cue Exposure Therapy Visit (CET I) will be eligible to be randomized to two visits of study medication and cue exposure treatment, spaced five to nine days apart. Subjects will complete 2 follow-up visits at 2-4 days and four weeks after the last CET visit. The entire study involves twelve visits and will last approximately ten weeks. For recently abstinent participants referred by a smoking cessation clinic, PCP or self referred, the study involves 7 visits (screening and baseline visit will be merged into one and there is no CBT component) and will last approximately 7 weeks.

NCT ID: NCT01387425 Completed - Diabetes Clinical Trials

Efficacy And Safety Of Smoking Cessation With Varenicline Tartrate In Diabetic Smokers: (DIASMOKE)

DIASMOKE
Start date: June 2011
Phase: N/A
Study type: Interventional

Objectives This protocol is intended to provide information regarding the efficacy and safety of the nicotine partial agonist varenicline tartrate, at a dose of 1 mg twice daily, for smoking cessation in diabetic subjects who smoke. Given that a better understanding of predictors of smoking cessation can be useful in identifying potential quitters and likely relapsers and that little is known about these predictors in diabetics, the role of different predictors of abstinence at the end of the study will also be examined Study Population The study will enroll 150 type 2 diabetic patients (≤ 75 years) who are regular smokers (≥10 cigs/day) and motivated to stop smoking in each of 2 treatment arms (active drug and placebo) Study Design The study is a double-blind, placebo-controlled, randomized clinical trial designed to assess the efficacy and safety of varenicline 1 mg BID in comparison to placebo for smoking cessation. The duration of active treatment will be 12 weeks and subjects will be followed in the nontreatment phase for an additional 12 weeks. This clinical study has an optional research component to prolong the follow up in the nontreatment phase for a full year. Predictors of abstinence at the end of the study will also be examined Study Endpoints Primary Endpoint: Success rates at week 24 in the varenicline vs placebo group. Success rates will be defined as the Continuous Quit Rate since last visit. Subjects will be classified as responders if they are able to maintain abstinence from cigarette smoking during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm. This measure will be obtained through reports of cigarette use by means of the Nicotine Use Inventory confirmed by a measurement of an end-expiratory exhaled carbon monoxide concentration that is ≤ 10 ppm on the study visit at week 24 Co-primary endpoint: Success rates at week 12 in the varenicline vs placebo group. Success rates will be defined as Continuous Quit Rate for Weeks 8 to 12 of treatment. Subjects will be classified as responders if they are able to maintain complete abstinence from cigarette smoking in each of the last four study visits (week 9, week 10, week 11, and week 12) with end-expiratory exhaled CO measurements ≤ 10 ppm. This measure will be obtained through reports of cigarette use by means of the Nicotine Use Inventory during the last four study visits (week 9, week 10, week 11, and week 12) confirmed by a measurement of an end-expiratory exhaled carbon monoxide concentration that is ≤ 10 ppm on each study visit Secondary Endpoint: Success rates at week 52 in the varenicline vs placebo group. Success rates will be defined as the Continuous Quit Rate throughout the last three visits (week 24, week 36, and week 44). Subjects will be classified as responders if they are able to maintain abstinence from cigarette smoking during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm. This measure will be obtained through reports of cigarette use by means of the Nicotine Use Inventory during the last three study visits (week 24, week 36 and week 44) confirmed by a measurement of an end-expiratory exhaled carbon monoxide concentration that is ≤ 10 ppm on each study visit Additional Measures: Given that a better understanding of predictors of smoking cessation can be useful in identifying potential quitters and likely relapsers and that little is known about these predictors in diabetics, the role of different predictors of abstinence at week 24 and at week 52 will also be examined

NCT ID: NCT01370356 Completed - Smoking Cessation Clinical Trials

A Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction

Start date: July 2011
Phase: Phase 4
Study type: Interventional

This study will determine whether varenicline is safe and helps people to quit smoking through reduction when they are not willing/able to make an abrupt quit attempt.