Varenicline for Cigarette Smoking in Schizophrenia - Efficacy and Predictors

This study is currently recruiting participants.

Verified by Manhattan Psychiatric Center, November 2009

First Received: December 4, 2008 Last Updated: November 9, 2009 History of Changes

Sponsor:	Manhattan Psychiatric Center
Information provided by:	Manhattan Psychiatric Center
ClinicalTrials.gov Identifier:	NCT00802919

Purpose

This is a 12-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. 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 hsitory of regular smokers.

Condition	Intervention	Phase
Schizophrenia Cigarette Smoking	Drug: Varenicline Drug: Placebo for varenicline	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Varenicline for Cigarette Smoking in Schizophrenia - Efficacy and Predictors, Independent Investigator Study

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia Smoking

Drug Information available for: Varenicline

U.S. FDA Resources

Further study details as provided by Manhattan Psychiatric Center:

Primary Outcome Measures:

Cotinine Level [ Time Frame: monthly ] [ Designated as safety issue: No ]
Scores on MATRICS Neuropsychological Battery [ Time Frame: baseline and end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PANSS Total Score [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
Hamilton Depression Scale Score [ Time Frame: baseline and end of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	September 2008
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Varenicline: Experimental Varenciline 1-2 mg/day	Drug: Varenicline Varenicline 1-2 mg/day
Matched Placebo: Placebo Comparator placebo for varenicline	Drug: Placebo for varenicline Placebo

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of Schizophrenia or Schizoaffective Disorder Current Cigarette Smoker Age 18-65 Currently taking antipsychotic medication

Exclusion Criteria:

prior history of hospitalization for acute myocardial infarction or stroke, or persistent angina pectoris with current symptoms Patients who have previously tried varenicline and have stopped taking it because of side-effects of severe nausea or vomiting suicide attempt in the last year and or have had prominent or serious suicidal thoughts in the past year Women who are pregnant, nursing, or unable to use reliable contraception significant renal impairment(Creatinine ≥ 1.5) baseline Hamilton Depression Scores is >20

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802919

Locations

United States, New York
Manhattan Psychatirc Center	Recruiting
New York City, New York, United States, 10035
Contact: Hannah Baldwin, MA 646-672-6964 Marchdb@omh.state.ny.us
Principal Investigator: Robert C Smith, MDm PhD

Sponsors and Collaborators

Manhattan Psychiatric Center

Investigators

Principal Investigator:

Robert C. Smith, MD, PhD

Manhattan Psychiatric Center

More Information

No publications provided

Responsible Party:	NYU School of Medicine & Manhattan Psychiatric Center ( Robert C. Smith MD PhD )
Study ID Numbers:	081/C02, FDA IND 102,411
Study First Received:	December 4, 2008
Last Updated:	November 9, 2009
ClinicalTrials.gov Identifier:	NCT00802919 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Manhattan Psychiatric Center:

schizophrenia
smoking
nicotine
cognitive deficits

DNMT1 mRNA
nicotinic receptors
Cognitive Deficits in Schizophrenia

Additional relevant MeSH terms:

Schizophrenia
Habits
Smoking
Mental Disorders

Tobacco Use Disorder
Substance-Related Disorders
Disorders of Environmental Origin
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on February 08, 2010