Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00455650
Status:
COMPLETED
Last Update Posted:
2017-03-28
First Post:
2007-04-02
Brief Title:
Study of the Effects of Mecamylamine and Varenicline in Schizophrenia
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Cognitive Effects of Mecamylamine and Varenicline in Schizophrenia
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 Trail Clinic of Massachusetts General Hospital for a Screening Visit If you agree to take part in the study a member of the study staff will explain the study to you and ask you to sign a consent form You will then have an interview with a study staff member
We will ask you questions about your current and past mental health and any symptoms you have experienced such as hearing voices We will ask you about previous smoking and your current medications We will review your medical record for psychiatric diagnosis and treatment Although we hope you will answer all the questions we ask you may skip over any you choose not to answer Your answers will be kept confidential
We will also give you a physical examination A doctor will fully examine you including listening to your heart and lungs and feeling your abdomen belly area We will also weigh you and take your blood pressure and pulse
We will need to take a sample of your breath to check for recent smoking We take this sample by asking you to breathe into a small hand-held machine This machine measures a gas in your breath carbon monoxide and tells us how much you smoke
We will ask you for a saliva sample to check for the use of nicotine and commonly used street drugs such as marijuana cocaine PCP opiates or amphetamines We do this by asking you to put a small sponge in your mouth The sponge soaks up a small sample of saliva If you test positive for any of these street drugs you will not be able to take part in the study The results of the saliva test will not become part of your medical record but will be recorded in the study records
If you qualify for the study we will arrange a date and time for you to return for the first of four study visits The four visits will be separated by approximately one week You will continue to take all your regular medications during this study unless instructed otherwise by a study physician
FIRST STUDY VISIT The first visit will last about 2½ hours in total At this visit you will practice the computer tasks included in the study until you are comfortable with them These tasks measure your concentration and memory You do not need to know how to use a computer to do these tasks They will take about 1½ hours in total to finish
In one task we will ask you to watch the screen very closely and press a button every time you see a certain combination of numbers In another task we will ask you to remember a letter or word and press the button when you see it again In another task you will need to remember the location of a cross and indicate to the location after a period of time In another task we will ask you to read words or colors off of a card
We will also ask you to fill out some questionnaires about your mood and other psychiatric symptoms These questionnaires take about 20-30 minutes to complete Although we hope you will answer all the questions you may skip over any questions that you dont choose to answer Your answers will be kept confidential These questionnaires are labeled with a number and your name does not appear on them The code that links numbers to names is kept in a locked cabinet in a different location Your initials will appear on questionnaires
During the computer tasks you will be allowed to take smoking breaks or rest breaks if you need to
TAKING THE STUDY DRUG OR PLACEBO You will receive mecamylamine one time varenicline one time and placebo one time during the course of this study but on different study days At the second third and fourth visits you will take one of the study drugs or the placebo but not both The order in which you take the medication or placebo will be assigned by chance like the flip of a coin Neither study staff nor you will know if you have received medication or placebo although we can find this out in an emergency
SECOND THIRD AND FOURTH STUDY VISITS At these next three study visits we will ask you to take a pill that either contains mecamylamine 10 mg varenicline 1 mg or placebo no active medications Prior to giving you the pill we will again ask for a saliva sample to test for nicotine and commonly used street drugs You will then relax and watch a movie for three hours We will provide a selection of DVDs for you to choose from and ask that you choose from among this selection We will provide food drinks and snacks and you will have a comfortable room to sit in If you prefer to bring your own food you may do that as well During this time we will take your blood pressure and pulse every 30 minutes and ask you to fill out a standard questionnaire that asks about side effects that will take 1-2 minutes
After 3 hours we will ask you to provide 3 tablespoons of your blood so that we can measure the amount of study medication in your blood We will destroy your blood sample at the end of the study You may choose not to have your blood drawn and you may still participate in the study
We will then ask you to complete the same tests and questionnaires that you did during the first study visit and one additional task in which you will be able to earn extra money during each visit This additional test is a game on the computer called the face game
These computer tasks and questionnaires will take about 2 to 2 ½ hours in total to complete During this time you will be able to take breaks to relax or smoke between tasks if needed
ADDITIONAL TASK AT THE END OF THE SECOND STUDY VISIT ONLY During the second visit after the completion of the normal study tasks we will ask you to do one additional task which gives you the opportunity to win money In this task we will ask you to sort cards into three different piles You will be given the money you have won as you leave the research center that day
SCREENING VISIT We will ask you to come to the Freedom Trail Clinic of Massachusetts General Hospital for a Screening Visit If you agree to take part in the study a member of the study staff will explain the study to you and ask you to sign a consent form You will then have an interview with a study staff member
We will ask you questions about your current and past mental health and any symptoms you have experienced such as hearing voices We will ask you about previous smoking and your current medications We will review your medical record for psychiatric diagnosis and treatment Although we hope you will answer all the questions we ask you may skip over any you choose not to answer Your answers will be kept confidential
We will also give you a physical examination A doctor will fully examine you including listening to your heart and lungs and feeling your abdomen belly area We will also weigh you and take your blood pressure and pulse
We will need to take a sample of your breath to check for recent smoking We take this sample by asking you to breathe into a small hand-held machine This machine measures a gas in your breath carbon monoxide and tells us how much you smoke
We will ask you for a saliva sample to check for the use of nicotine and commonly used street drugs such as marijuana cocaine PCP opiates or amphetamines We do this by asking you to put a small sponge in your mouth The sponge soaks up a small sample of saliva If you test positive for any of these street drugs you will not be able to take part in the study The results of the saliva test will not become part of your medical record but will be recorded in the study records
If you qualify for the study we will arrange a date and time for you to return for the first of four study visits The four visits will be separated by approximately one week You will continue to take all your regular medications during this study unless instructed otherwise by a study physician
FIRST STUDY VISIT The first visit will last about 2½ hours in total At this visit you will practice the computer tasks included in the study until you are comfortable with them These tasks measure your concentration and memory You do not need to know how to use a computer to do these tasks They will take about 1½ hours in total to finish
In one task we will ask you to watch the screen very closely and press a button every time you see a certain combination of numbers In another task we will ask you to remember a letter or word and press the button when you see it again In another task you will need to remember the location of a cross and indicate to the location after a period of time In another task we will ask you to read words or colors off of a card
We will also ask you to fill out some questionnaires about your mood and other psychiatric symptoms These questionnaires take about 20-30 minutes to complete Although we hope you will answer all the questions you may skip over any questions that you dont choose to answer Your answers will be kept confidential These questionnaires are labeled with a number and your name does not appear on them The code that links numbers to names is kept in a locked cabinet in a different location Your initials will appear on questionnaires
During the computer tasks you will be allowed to take smoking breaks or rest breaks if you need to
TAKING THE STUDY DRUG OR PLACEBO You will receive mecamylamine one time varenicline one time and placebo one time during the course of this study but on different study days At the second third and fourth visits you will take one of the study drugs or the placebo but not both The order in which you take the medication or placebo will be assigned by chance like the flip of a coin Neither study staff nor you will know if you have received medication or placebo although we can find this out in an emergency
SECOND THIRD AND FOURTH STUDY VISITS At these next three study visits we will ask you to take a pill that either contains mecamylamine 10 mg varenicline 1 mg or placebo no active medications Prior to giving you the pill we will again ask for a saliva sample to test for nicotine and commonly used street drugs You will then relax and watch a movie for three hours We will provide a selection of DVDs for you to choose from and ask that you choose from among this selection We will provide food drinks and snacks and you will have a comfortable room to sit in If you prefer to bring your own food you may do that as well During this time we will take your blood pressure and pulse every 30 minutes and ask you to fill out a standard questionnaire that asks about side effects that will take 1-2 minutes
After 3 hours we will ask you to provide 3 tablespoons of your blood so that we can measure the amount of study medication in your blood We will destroy your blood sample at the end of the study You may choose not to have your blood drawn and you may still participate in the study
We will then ask you to complete the same tests and questionnaires that you did during the first study visit and one additional task in which you will be able to earn extra money during each visit This additional test is a game on the computer called the face game
These computer tasks and questionnaires will take about 2 to 2 ½ hours in total to complete During this time you will be able to take breaks to relax or smoke between tasks if needed
ADDITIONAL TASK AT THE END OF THE SECOND STUDY VISIT ONLY During the second visit after the completion of the normal study tasks we will ask you to do one additional task which gives you the opportunity to win money In this task we will ask you to sort cards into three different piles You will be given the money you have won as you leave the research center that day
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CORRC3-2007 | None | None | None |