Study of the Effects of Mecamylamine and Varenicline in Schizophrenia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Massachusetts General Hospital.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Massachusetts General Hospital
Collaborators:
National Alliance for Research on Schizophrenia and Depression
The Bowman Family Foundation
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00455650
First received: April 2, 2007
Last updated: November 25, 2009
Last verified: November 2009
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Purpose
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 products. Our subjects will be people with and without mental illness (schizophrenia), smokers and non-smokers.
We will use a medication called mecamylamine (Inversine) to block the effects of nicotine on the brains of our subjects. We will also use a medication called varenicline (Chantix) to partially increase the effects of nicotine on the brains of our subjects. This study also uses a placebo, a pill that does not have any active ingredients but looks exactly like the mecamylamine and varenicline pills. We will compare the effects of giving mecamylamine or placebo to people who have schizophrenia and people who do not have schizophrenia.
We know that people with schizophrenia smoke heavily and find it harder to stop smoking than most other people do. Studies have shown that people with schizophrenia may smoke more because nicotine helps their concentration and memory. We are interested in helping people with schizophrenia smoke less. Mecamylamine blocks the parts of the brain that react to nicotine and varenicline partially stimulates and partially blocks the parts of the brain that react to nicotine. Both medications may decrease the effects that smoking has on the body.
| Condition | Intervention |
|---|---|
|
Cognition in Schizophrenia |
Drug: Mecamylamine Drug: Varenicline Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Cognitive Effects of Mecamylamine and Varenicline in Schizophrenia |
Resource links provided by NLM:
Drug Information available for:
Mecamylamine
Mecamylamine hydrochloride
Varenicline
Varenicline tartrate
U.S. FDA Resources
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Change from baseline reaction time for correct responses on the CPT-IP continuous performance task [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Effects of mecamylamine and varenicline compared with placebo in schizophrenia and control groups on response bias, reaction time, errors of commission and errors of omission [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Mecamylamine |
Drug: Mecamylamine
A single dose of 10 mg of mecamylamine (via two 5 mg capsules) is given at the start of the mecamylamine arm of the study. This is the only administration of mecamylamine given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
Other Name: Inversine
|
| Active Comparator: Varenicline |
Drug: Varenicline
A single dose of 1 mg of varenicline (via two 0.5 mg capsules) is given at the start of the varenicline arm of the study. This is the only administration of varenicline given during the course of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance.
Other Name: Chantix
|
| Placebo Comparator: Placebo |
Drug: Placebo
The placebo contains no active medication. The placebo dose is given via two capsules at the start of the placebo arm of the study. Participants' blood pressure and vitals are checked regularly for five hours after drug administration for monitoring and safety assurance. The placebo has no effects that last for any duration of time.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 68 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00455650
Locations
| United States, Massachusetts | |
| Freedom Trail Clinic, Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
Sponsors and Collaborators
Massachusetts General Hospital
National Alliance for Research on Schizophrenia and Depression
The Bowman Family Foundation
Investigators
| Principal Investigator: | A. Eden Evins, MD, MPH | Massachusetts General Hospital |
| Study Director: | Catherine Fullerton, M.D., M.P.H. | Massachusetts General Hospital |
More Information
Publications:
| Responsible Party: | A. Eden Evins, M.D., MPH, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00455650 History of Changes |
| Other Study ID Numbers: | PHRC #2006-P-001361, CORRC#3-2007 |
| Study First Received: | April 2, 2007 |
| Last Updated: | November 25, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
schizophrenia cognition nicotinic receptors mecamylamine varenicline |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Mecamylamine Varenicline Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Ganglionic Blockers |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Nicotinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Nicotinic Agonists Cholinergic Agonists |
ClinicalTrials.gov processed this record on May 19, 2013