CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 93 enrolled
Drug / intervention
Varenicline +1 moredrug
Likely dose
Varenicline 2 mgfrom 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.

Search/NCT00802919
NCT00802919Phase 4Completed
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Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors, Independent Investigator Study

Nathan Kline Institute for Psychiatric Research·interventional·Posted Dec 5, 2008·Updated Dec 2, 2017

In Brief

A Phase 4 clinical trial evaluating Varenicline and Placebo for varenicline for Schizophrenia and Cigarette Smoking. Completed, enrolled 93 participants across 4 sites in 3 countries.

Detailed Summary

This is a 8-week double-blind placebo controlled parallel group study of the efficacy of varenicline (Chantix) for smoking cessation in schizophrenic patients, and its effect on cognitive function in patients with schizophrenia.At some sits evaluation of smoking measures is extended to 12 weeks. Correlations will be made with biological predictors of efficacy: a) measures of nicotinic receptors in lymphocytes b) DNMT1 and GAD67 mRNA in lymphocytes. Subjects will be current cigarette smokers or history of regular smokers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Cigarette Smoking
CountriesChina, Israel, United States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 5, 2008
Enrollment StartSep 1, 2008
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 17.6 years ago

Interventions

Vareniclinedrug

Varenicline 1-2 mg/day

Placebo for vareniclinedrug

Placebo