At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 128 enrolled
Drug / intervention
placebo +1 moredrug
Likely dose
varenicline (CP-526,555) 1mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3B 12-Week, Double -Blind, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Varenicline Tartrate (CP-526,555) 1 mg BID for Smoking Cessation in Subjects With Schizophrenia and Schizoaffective Disorder.
In Brief
A Phase 3 clinical trial evaluating placebo and varenicline (CP-526,555) for Smoking Cessation. Completed, enrolled 128 participants across 14 sites in 2 countries.
Detailed Summary
Study will determine whether patients with schizophrenia or schizoaffective disorder can be helped to quit smoking safely while using varenicline and receiving smoking cessation counseling.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking Cessation
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2008
Enrollment StartMay 2008
Primary CompletionApr 2010
TodayJul 2026
First PostedMar 27, 2008
Enrollment StartMay 1, 2008
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 18.3 years ago
Interventions
placebodrug
Randomization 2:1 treatment to placebo
varenicline (CP-526,555)drug
One week of titration up to 1mg bid and 11 weeks of dosing at 1mg bid