The Effects of Nicotine on Cognition in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: transdermal nicotine patch; Transdermal Nicotine Patch
Intervention description: 14mg transdermal nicotine application; 14mg transdermal nicotine application
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cognition; nicotine; schizophrenia

Summary:

      Patients with schizophrenia have a variety cognitive deficits and nicotine has been shown to
      normalize some of these deficits. The purpose of this study is to investigate the effects of
      nicotine on cognition in schizophrenia.We will evaluate the effects of transdermal nicotine
      compared with placebo for attentional impairments in non-smokers with schizophrenia and
      controls.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients:

          -  DSM IV diagnosis of schizophrenia,

          -  age 18 - 60 inclusive,

          -  able to provide informed consent,

          -  treated with antipsychotic medications at a stable dose for at least 4 weeks,

          -  not treated with an investigational medication in the past 30 days,

          -  WRAT-3 IQ raw score greater than or equal to 35,

          -  non smokers for more than 3 months*,

          -  normal or corrected to normal vision.

        Non Smoking defined by:

          1. Self report of not smoking a single cigarette in the past 3 months.

          2. Salivary Cotinine level < 30 ng/ml at screening and on the day of testing

          3. Expired air CO < 9ppm on the day of the testing

        Inclusion Criteria:

        Control Group:

          -  Age 18 - 60 inclusive,

          -  able to provide informed consent,

          -  not treated with an investigational medication in the past 30 days,

          -  WRAT-3 IQ raw score greater than or equal to 35,

          -  non smokers for more than 3 months*,

          -  normal or corrected to normal vision,

          -  Non Smoking as defined above.

        Exclusion Criteria:

        Patients:

          -  Use of any nicotine containing product in the past 3 months by self report,

          -  use of cholinesterase inhibitors such as galantamine in the past 3 months,

          -  untreated ischaemic heart disease,

          -  uncontrolled hypertension,

          -  current unstable serious medical illness (renal, neoplastic, hematological),

          -  allergy to patches.

          -  Currently or planning to be pregnant in the next 8 weeks, as verified by positive
             pregnancy test, or childbearing potential and not using adequate contraception. Those
             not of childbearing potential include post-menopausal, surgically sterilized, and male
             participants.

          -  Substance abuse in the past month: self-reported, diagnosed during chart review, and
             verified by a positive salivary test for cotinine, cocaine, methamphetamine,
             amphetamine, ethanol, TCH, opiates or PCP at screen.

          -  Recent deterioration in mental state, current major depressive disorder, history of
             cognitive impairment secondary to other disorders such as head injury, dementia,
             general medical condition, diagnosis of mental retardation

        Exclusion criteria:

        Controls:

          -  Past or present DSM IV diagnosis of schizophrenia, schizoaffective disorder, major
             depression, bipolar disorder, or mental retardation.

          -  First degree relative with diagnosis of schizophrenia or schizoaffective disorder,

          -  use of cholinesterase inhibitors such as galantamine in the past 3 months,

          -  untreated ischaemic heart disease,

          -  uncontrolled hypertension,

          -  current unstable serious medical illness (renal, neoplastic, hematological,)

          -  allergy to patches,

          -  currently or planning to be pregnant in the next 8 weeks, as verified by positive
             pregnancy test, or childbearing potential and not using adequate contraception. Those
             not of childbearing potential include post-menopausal, surgically sterilized, and male
             participants.

          -  Substance abuse in the past month: self-reported, diagnosed during chart review, and
             verified by a positive salivary test for cotinine, cocaine, methamphetamine,
             amphetamine, ethanol, TCH, opiates and PCP at screen.

          -  History of cognitive impairment secondary to other disorders such as head injury,
             dementia, general medical condition