Status:
COMPLETED
The Effects of Nicotine on Cognition in Schizophrenia
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Stanley Medical Research Institute
North Suffolk Mental Health Association
Conditions:
Schizophrenia
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief 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 co...
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 medicat...
Eligibility Criteria
Inclusion
- 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:
- Self report of not smoking a single cigarette in the past 3 months.
- Salivary Cotinine level \< 30 ng/ml at screening and on the day of testing
- Expired air CO \< 9ppm on the day of the testing
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00383747
Start Date
April 1 2004
End Date
January 1 2009
Last Update
April 28 2017
Active Locations (1)
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1
Massachusetts General Hospital Schizophrenia Research Program
Boston, Massachusetts, United States, 02114