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Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Robert C. Smith MD PhD, Nathan Kline Institute for Psychiatric Research.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Robert C. Smith MD PhD, Nathan Kline Institute for Psychiatric Research Identifier:
First received: December 4, 2008
Last updated: May 16, 2012
Last verified: May 2012
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
Cigarette Smoking
Drug: Varenicline
Drug: Placebo for varenicline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors, Independent Investigator Study

Resource links provided by NLM:

Further study details as provided by Robert C. Smith MD PhD, Nathan Kline Institute for Psychiatric Research:

Primary Outcome Measures:
  • Cotinine Level [ Time Frame: monthly ]
  • Scores on MATRICS Neuropsychological Battery [ Time Frame: baseline and end of study ]

Secondary Outcome Measures:
  • PANSS Total Score [ Time Frame: monthly ]
  • Calgary Depression Scale Score [ Time Frame: baseline and monthly ]

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
Experimental: Varenicline
Varenciline 1-2 mg/day
Drug: Varenicline
Varenicline 1-2 mg/day
Other Name: Chantix
Placebo Comparator: Matched Placebo
placebo for varenicline
Drug: Placebo for varenicline


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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Please refer to this study by its identifier: NCT00802919

United States, New York
Manhattan Psychatirc Center Completed
New York City, New York, United States, 10035
Nathan Kline Insitute for Psychiatric Research Recruiting
Orangeburg,, New York, United States, 10962
Contact: Lawrence Maayan, MD    845-398-6637   
Contact: Robert C smith, MD PhD    845-398-6531   
Principal Investigator: Lawrence Maayan, MD         
The Division of Psychiatry, Chaim Sheba Medical Center Recruiting
Tel Hashomer, Israel, 52621
Contact: Revital Amiaz, MD    +972-3-530-3774   
Principal Investigator: Revital Amiaz, MD         
Sponsors and Collaborators
Nathan Kline Institute for Psychiatric Research
Principal Investigator: Robert C. Smith, MD, PhD Manhattan Psychiatric Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Robert C. Smith MD PhD, Research Psychiatrist, Principal Investigagtor, Nathan Kline Institute for Psychiatric Research Identifier: NCT00802919     History of Changes
Other Study ID Numbers: 081/C02
FDA IND 102,411
Study First Received: December 4, 2008
Last Updated: May 16, 2012

Keywords provided by Robert C. Smith MD PhD, Nathan Kline Institute for Psychiatric Research:
cognitive deficits
nicotinic receptors
Cognitive Deficits in Schizophrenia

Additional relevant MeSH terms:
Cognition Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Neurocognitive Disorders
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 25, 2017