The Effects of Nicotine on Cognition in Schizophrenia
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Device: transdermal nicotine patch Device: Transdermal Nicotine Patch |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Double Blind Placebo Controlled Trial of the Effects of Transdermal Nicotine on Cognitive Function in Non-Smokers With and Without Schizophrenia |
- d' measure on the Continuous Performance Test identical pairs version [ Time Frame: Session 1-4 ] [ Designated as safety issue: No ]
- Reward Responsivity using a signal detection task [ Time Frame: Session 0,2, and 4 ] [ Designated as safety issue: No ]
- Connor's Continuous Performance Test [ Time Frame: Session 1-4 ] [ Designated as safety issue: No ]
- Stroop [ Time Frame: Session 1-4 ] [ Designated as safety issue: No ]
- Letter Number Span [ Time Frame: Session 1-4 ] [ Designated as safety issue: No ]
- Grooved Pegboard [ Time Frame: Session 1 -4 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2004 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Nicotine Patch |
Device: transdermal nicotine patch
14mg transdermal nicotine application
Other Name: Nicoderm CQ patch
|
| Placebo Comparator: Placebo Nicotine Patch |
Device: Transdermal Nicotine Patch
14mg transdermal nicotine application
|
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
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.
- 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
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Priscilla Sinclair, BA | 617-912-7829 | psinclair1@partners.org |
| Contact: Alice Coakley, BA | 617-912-7863 | acoakley1@partners.org |
| United States, Massachusetts | |
| Massachusetts General Hospital Schizophrenia Research Program | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Priscilla Sinclair, B.A. 617-912-7829 psinclair1@partners.org | |
| Contact: Alice Coakley, B.A. (617) 912-7863 acoakley1@partners.org | |
| Principal Investigator: A E EVINS, MD MPH | |
| Principal Investigator: | A E EVINS, MD MPH | Massachusetts General Hosptal |
More Information
No publications provided by Massachusetts General Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | A Eden Evins, MD, MPH, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00383747 History of Changes |
| Other Study ID Numbers: | 04T574, CORRC 07-2004 |
| Study First Received: | September 29, 2006 |
| Last Updated: | May 3, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Massachusetts General Hospital:
|
cognition nicotine schizophrenia |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Nicotine Nicotine polacrilex Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013