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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

Clinical Trials [1208 Associated Clinical Trials listed on BioPortfolio]

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 [2134 Associated PubMed Articles listed on BioPortfolio]

An RCT with the Combination of Varenicline and Bupropion for Smoking Cessation: Clinical Implications for Front Line Use.

Despite the availability of several efficacious smoking cessation treatments, less than 25% of smokers who quit remain abstinent 1 year post treatment. This study aimed to determine if varenicline and...

Pilot Randomized Trial of an Automated Smoking Cessation Intervention via Mobile Phone Text Messages as an Adjunct to Varenicline in Primary Care.

Varenicline is a safe and effective aid to smoking cessation but most trials have involved frequent visits or intensive behavioral support unlike that typically provided in primary care. The current s...

Impurity profiling of varenicline tartrate by LC-QTOF mass spectrometric techniques during drug development.

An LC-QTOF-MS method was developed for the separation and characterization of related substances in varenicline tartrate. The separation was established on an InertSustain C18 column (4.6 mm × 15...

Systematic Review and Meta-Analysis to Assess the Safety of Buproprion and Varenicline in Pregnancy.

Smoking in pregnancy is a substantial public health issue, but, apart from nicotine replacement therapy (NRT), pharmacological therapies are not generally used to promote cessation. Bupropion and vare...

Understanding the link between contingency management and smoking cessation: The roles of sex and self-efficacy.

Little is known about the mechanisms linking contingency management (CM) treatment with smoking cessation, and recent research suggests that the CM approach is associated with better smoking cessation...

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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