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Full description
Objective:
Specific aim 1: To test the hypothesis that individuals with comorbid schizophrenia and drug dependence will show impaired neurocognitive functions in anticipatory learning of eyetracking, attention, and memory performance compared to healthy controls subjects.
Specific aim 2: To test the hypothesis that nicotine will dose-dependently improve anticipatory learning of eyetracking, attention, and memory performance in individuals with comorbid schizophrenia and substance dependence.
Study Population:
Male and nonpregnant-female smokers 18 to 55 years of age, from the following subject groups: (1) patients with a DSM IV diagnosis of schizophrenia (2) patients with dual DSM IV diagnoses of schizophrenia and heroin and/or cocaine dependence or abuse, or on methadone or beprenorphine maintenance and (3) healthy individuals with no family history of psychotic illness.
Design:
This study will be a double-blind, placebo controlled trial of nicotine or placebo nasal sprays. Participants will have four visits. After the training session, participants will be administered one dose (0, 1 or 2 mg) of nicotine nasal spray during each of the 3 experimental sessions. The dose will be given 5 minutes prior to the cognitive task batteries.
Outcome Measures:
Vital signs, moods, and performance on tasks assessing eye movement (initiation latency, initiation acceleration, closed-loop pursuit gain), attention (Continuous Performance and Digit Symbol Substitution Tasks), and memory (delayed recognition and nback).
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Inclusion and exclusion criteria
All participants must meet the following criteria:
Experimental groups 1 and 2, additional criteria:
-DSM-IV diagnosis of schizophrenia or schizoaffective disorder (assessments pertaining to these diagnoses will be done in other MPRC screening protocols).
Experimental group 2, additional criteria:
-DSM-IV diagnosis of abuse or dependence on cocaine and/or heroin or on methadone or buprenorphine maintenance.
EXCLUSION CRITERIA:
Comprehensive medical history:
-Exclusions: Heart disease, uncontrolled blood pressure (persistent systolic above 155 or diastolic above 95), neurological conditions (stroke, seizure, history of head injury), asthma, emphysema, chronic bronchitis, chronic obstructive pulmonary disease, pathology of nasal passages that precludes the effective administration of nicotine nasal spray.
Drug Use Survey
All subjects:
Structured Clinical Interview for DSM-IV
-Healthy controls: exclude if any current psychiatric disorder
Urine pregnancy for females:
-Exclude if positive.
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Data sourced from clinicaltrials.gov
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