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Assessment of Safety and Efficacy of Varenicline in Patients That Wish to Stop Smoking

2014-08-27 03:33:46 | BioPortfolio

Summary

The primary objective of this protocol is to evaluate 12 weeks of treatment of varenicline compared to placebo for smoking cessation. Abstinence from cigarette smoking and other tobacco products (e.g., pipe, cigars, chew, snuff.) use during non-treatment follow-up period will also be evaluated.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Smoking Cessation

Intervention

varenicline tartrate (CP-526, 555-18), Placebo

Location

Pfizer Investigational Site
Porto Alegre
Centro
Brazil
RS

Status

Completed

Source

Pfizer

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:33:46-0400

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Multiple Dose, Dose Escalation Study of Varenicline Controlled Release Formulation in Adult Smokers

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of escalating multiple oral doses of varenicline AMT 8 controlled release formulation for 14 days in ...

An Investigation of Effectiveness and Safety of Varenicline Tartrate in Helping People Quit Smoking

To investigate safety and efficacy of varenicline tartrate in helping people quit smoking

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

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...

Comparison of Varenicline and Placebo for Smoking Cessation in Schizophrenia

The purpose of this proposed pilot study is to examine the use of varenicline in people with schizophrenia to specifically assess tolerability and efficacy for smoking cessation. Specifica...

Long-term Varenicline Treatment for Smoking Cessation

This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy in conjunction with individual counseling for smoking cessation. Adult volunteers in generally...

PubMed Articles [2131 Associated PubMed Articles listed on BioPortfolio]

Varenicline for long term smoking cessation in patients with COPD.

Quitting smoking is key for patients with Chronic Obstructive Pulmonary Disease (COPD). Standard recommendations for quitting smoking are implemented for COPD as well. Varenicline Tartrate (VT) is the...

The effectiveness, safety and cost-effectiveness of cytisine versus varenicline for smoking cessation in an Australian population: A study protocol for a randomised controlled non-inferiority trial.

Smoking cessation medications are effective but often underutilised because of costs and side effects. Cytisine is a plant-based smoking cessation medication with over 50 years of use in Central and E...

Integrated Treatment for Smoking Cessation, Anxiety, and Depressed Mood in People Living With HIV: A Randomized Controlled Trial.

Among people living with HIV, cigarette smoking rates are higher than among the general population, and anxiety, depression, and their disorders are common and associated with smoking and poorer outco...

Associations of the Stoptober smoking cessation program with information seeking for smoking cessation: A Google trends study.

The national smoking cessation program Stoptober was introduced in October 2012 in England and in October 2014 in the Netherlands. There is little evidence on the extent to which the Stoptober program...

Algorithm for resolving discrepancies between claims for smoking cessation pharmacotherapies during pregnancy and smoking status in delivery records: The impact on estimates of utilisation.

The linkage of routine data collections are valuable for population-based evaluation of smoking cessation pharmacotherapy in pregnancy where little is known about the utilisation or safety of these ph...

Medical and Biotech [MESH] Definitions

A benzazepine derivative that functions as an ALPHA4/BETA2 NICOTINIC RECEPTOR partial agonist. It is used for SMOKING CESSATION.

A decrease in the incidence and frequency of SMOKING. Smoking reduction differs from SMOKING CESSATION in that the smoker continues to smoke albeit at a lesser frequency without quitting.

Discontinuation of the habit of smoking, the inhaling and exhaling of tobacco smoke.

Cessation of the habit of using tobacco products for smoking or chewing, including the use of snuff.

A unicyclic, aminoketone antidepressant. The mechanism of its therapeutic actions is not well understood, but it does appear to block dopamine uptake. The hydrochloride is available as an aid to smoking cessation treatment.

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