Phase 4
N=60
The Effects of Nicotine on Cognition in Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00383747 ↗Enrolled (actual)
60
Serious AEs
3.3%
Results posted
Apr 2017
Primary outcome: Primary: Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Attention Measured by the Continuous Performance Test Identical Pairs Version — 2.2; 2.1; 3.4; 3.2 milliseconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- transdermal nicotine patch (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Attention Measured by the Continuous Performance Test Identical Pairs Version |
2.2; 2.1; 3.4; 3.2 | — |
| SECONDARY Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Visual Attention and Cognitive Interference as Measured by Three Card Stroop |
50.4; 49.0; 56.8; 58.8 | — |
| SECONDARY Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Letter Number Sequencing |
12.6; 12.5; 15.5; 15.9; 8.8; 9.0 | — |
| SECONDARY Effects of Nicotine Patch Compared With Placebo in Non- Smokers With Schizophrenia and Control Groups on Lateralized Psychomotor Speed Measured by the Grooved Pegboard |
14.4; 14.5; 19.1; 18.6 | — |
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:
- 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
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
Data sourced from ClinicalTrials.gov (NCT00383747). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.