drugset / Trial / NCT01093937

Study of Varenicline (Champix) for Smoking Cessation/Reduction in Patients With Bipolar Disorder

NCT01093937

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Bipolar Disorder is a chronic relapsing mental disorder characterized by periods of elevated, expansive and irritable mood, often alternating with periods of significant clinical depression. People with Bipolar Disorder are typically heavy smokers who have difficulty quitting, and this is associated with significant tobacco-related medical illness and death. The proposed study will be a double-blind, placebo-controlled 10-week clinical trial of the safety and efficacy of varenicline (Champix™) in thirty subjects with Bipolar I Disorder. This medication is the latest first-line pharmacotherapy for smoking cessation and has been shown to be efficacious for smoking cessation, but has not yet been systematically studied in persons with Bipolar Disorder.

Timeline

Start
2009-11
Primary completion
2011-02
Completion
2011-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Varenicline Small molecule 0.5 mg Oral
Subject Varenicline Small molecule 2 mg Oral

Indications