The Effects of Nicotine on Cognition in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      We propose to test the efficacy and safety of transdermal nicotine for attention and working
      memory in outpatients with stable symptoms of schizophrenia treated with high potency
      antipsychotic medications that do not smoke cigarettes or use nicotine-containing products.
      This is a randomized, double-blind, placebo-controlled pilot study to determine whether
      transdermal nicotine, initiated in a clinic setting and dosed for four hours is safe and
      effective for improving attention and spatial working memory deficits in patients with
      schizophrenia. This is an add-on study, subjects will continue with their usual medications
      and treatments throughout.

      Subjects are 30- non-smoking outpatients with stable treated schizophrenia and 30 normal
      controls who do not have a major mental illness and who are matched for age sex and parental
      education. Subjects are randomized to one of 2 groups for order of receiving active and
      placebo patch, using a computer generated random number sequence. Randomization is concealed
      using opaque envelopes. Assessors and subjects are blind to group allocation.

      The primary outcome measure is d' measure on the CPT-IP following a 4 hour administration of
      the transdermal nicotine patch. Secondary outcome measures are performance on tasks assessing
      attention, numeric and visuospatial working memory, psychomotor ability, executive
      functioning and motivation for reward following nicotine patch administration.

      Specific Aims

        1. To evaluate the effectiveness of transdermal nicotine compared with placebo for
           attentional impairment in patients with schizophrenia

           Hypothesis 1.1: Subjects will demonstrate greater signal detection as measured by the d'
           (hits vs. false alarms) on the Continuous Performance Test Identical Pairs Version
           (CPT-IP) following 4-hour nicotine administration when compared with placebo
           administration.

           Hypothesis 1.2: Subjects will demonstrate decreased false alarms on the CPT-IP following
           4-hour nicotine administration when compared with placebo administration.

           Hypothesis 1.3: Subjects will demonstrate decreased reaction time on the CPT-IP
           following 4- hour nicotine administration when compared with placebo administration.

        2. To evaluate the effect of transdermal nicotine in patients with schizophrenia compared
           with normal matched controls

      Hypothesis 2.1: Schizophrenia subjects will demonstrate greater improvement in signal
      detection as measured by the d' (hits vs. false alarms) on the Continuous Performance test
      identical pairs version(CPT-IP) following 4-hour nicotine administration when compared with
      normal controls.

      Hypothesis 2.2: Schizophrenia subjects will demonstrate greater reduction in false alarms on
      the CPT-IP following 4-hour nicotine administration when compared with normal controls.

      Hypothesis 2.3: Schizophrenia subjects will demonstrate decreased reaction time on the CPT-IP
      following 4- hour nicotine administration when compared with normal controls. Performance
      Test Identical Pairs Version
    

Intervention name(s): transdermal nicotine patch; Transdermal Nicotine Patch
Intervention type(s): Drug; Drug
Intervention description(s): 14mg transdermal nicotine application; 14mg transdermal nicotine application
Other intervention name(s): Nicoderm CQ patch
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: cognition; nicotine; schizophrenia