Status:
COMPLETED
Study of the Effects of Mecamylamine and Varenicline in Schizophrenia
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Alliance for Research on Schizophrenia and Depression
The Bowman Family Foundation
Conditions:
Cognition in Schizophrenia
Eligibility:
All Genders
18-68 years
Phase:
NA
Brief Summary
We are conducting this study to find out if blocking or partially stimulating the effects of nicotine in the brain can affect memory and concentration. Nicotine is the addictive drug found in tobacco ...
Detailed Description
Taking part in this study will involve one Screening Visit and four Study Visits, all of which will take part over a period of about 3-5 weeks. SCREENING VISIT We will ask you to come to the Freedom ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Patients with Schizophrenia:
- Males or females ages 18-68
- Axis I diagnosis of schizophrenia or schizoaffective disorder
- Smoking or Non-smoking
- Negative salivary screen for drugs of abuse
- Stable psychiatric treatment for 4 weeks
- Exclusion Criteria for Patients with Schizophrenia
- Current (within the last 6 months) DSM-IV diagnosis of bipolar disorder, PTSD, organic mental disorder, or anorexia nervosa
- Substance use disorder other than nicotine or caffeine in the past 6 months
- Orthostatic blood pressure changes at 3 minutes of \> 20 mm Hg systolic or 10 mm Hg diastolic
- Blood Pressure: Women under 50 years of age: Supine baseline systolic blood pressure \< 90 mm Hg; Men under 50 years of age: Supine baseline systolic blood pressure \< 100 mm Hg; Women and men over 50 years of age: Supine baseline systolic blood pressure \< 110 mm Hg
- History of angina, MI within the past 2 years, CHF with LVEF \< 40%
- History of syncope or neurocardiogenic syncope
- History of stroke or TIA's
- Glaucoma
- Pyloric Stenosis
- Current pregnancy or lactation
- Renal Insufficiency/Uremia
- Known allergy to mecamylamine
- Inability to give informed consent
- Cognitive impairment secondary to head injury, dementia, general medical condition, or mental retardation
- Current use of antibiotics or sulfa drugs, vasodilators such as alpha blocking agents and nitrates
- Use of investigational medication or device within one month of randomization
- Chronic use of antihypertensive drugs, including diuretics, will be considered on an individual basis
- Inclusion Criteria for Healthy Controls:
- Males or females ages 18-68
- Smoking or Non-smoking
- Negative salivary screen for drugs of abuse
- Exclusion Criteria for Healthy Controls:
- Current or lifetime Axis I DSM-IV diagnosis or family history of schizophrenia, schizoaffective disorder, or bipolar disorder
- Current (within past 6 months) Axis I DSM-IV diagnosis of major depressive disorder, eating disorder, generalized anxiety disorder or PTSD
- Substance use disorder other than nicotine or caffeine in the past 6 months
- Orthostatic blood pressure changes at 3 minutes of \> 20 mm Hg systolic or 10 mm Hg diastolic
- Blood Pressure: Women under 50 years of age: Supine baseline systolic blood pressure \< 90 mm Hg; Men under 50 years of age: Supine baseline systolic blood pressure \< 100 mm Hg; Women and men over the age of 50: Supine baseline systolic blood pressure \< 110 mm Hg
- History of angina, MI within the past 2 years, CHF with LVEF \< 40%
- History of syncope or neurocardiogenic syncope
- History of stroke or TIA's
- Glaucoma
- Pyloric Stenosis
- Current pregnancy or lactation
- Renal Insufficiency/Uremia
- Known allergy to mecamylamine
- Inability to give informed consent
- Cognitive impairment secondary to head injury, dementia, general medical condition, or mental retardation
- Current use of antibiotics or sulfa drugs, vasodilators such as alpha blocking agents and nitrates
- Use of investigational medication or device within one month of randomization
- Chronic use of antihypertensive drugs, including diuretics, will be considered on an individual basis
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00455650
Start Date
March 1 2007
End Date
January 1 2013
Last Update
March 28 2017
Active Locations (1)
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1
Freedom Trail Clinic, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114