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| ID | Type | Description | Link |
|---|---|---|---|
| K08GM083213 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of General Medical Sciences (NIGMS) | NIH |
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People often develop fearful responses to things, but have no conscious control over the fear. This is a basic form of unconscious memory, called "fear conditioning." Intravenous anesthetic drugs have remarkable effects on conscious memory, but it is unknown whether they have similar effects on these unconscious fear memories.
To address this question, the investigators will study 114 healthy adult volunteer subjects. The subject is given a very low dose of an anesthetic drug intravenously (i.e. through the bloodstream). The dose is so low that the subject might not even be able tell if they are getting the drug. While they are receiving the drug, the subject will perform a series of memory tests and a fear conditioning experiment, which are set up like a very simple computer game. To create the "fear response", subjects will occasionally receive a mildly uncomfortable shock to their arm. The subject is able to determine the highest level of shock that they will receive.
The investigators are doing this study because the investigators wish to know exactly how the drugs affect the way people process fear and emotion. This knowledge might one day be used in the treatment of some psychiatric disorders.
People often develop fearful responses to things, but have no conscious control over the fear (e.g. phobias). This is a basic form of unconscious memory, called "fear conditioning." Intravenous anesthetic drugs have remarkable effects on conscious memory, but it is unknown whether they have similar effects on these unconscious fear memories.
To address this question, the investigators will study 114 healthy adult volunteer subjects. The subject is given a very low dose of an anesthetic drug intravenously (i.e. through the bloodstream). The dose is so low that the subject might not even be able tell if they are getting the drug. While they are receiving the drug, the subject will perform a series of memory tests and a fear conditioning experiment, which are set up like a very simple computer game. To create the "fear response", subjects will occasionally receive a mildly uncomfortable shock to their arm. The subject is able to determine the highest level of shock that they will receive.
The investigators are doing this study because the investigators wish to know exactly how the drugs affect the way people process fear and emotion. This knowledge might one day be used in the treatment of some psychiatric disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebos | Placebo Comparator | Saline Infusion |
|
| Propofol 0.45mcg/mL | Active Comparator | Anesthetic Drug Infusion |
|
| Propofol 0.90mcg/mL | Active Comparator | Anesthetic Drug Infusion |
|
| Thiopental 1.5mcg/mL | Active Comparator | Anesthetic Drug Infusion |
|
| Thiopental 3mcg/mL | Active Comparator | Anesthetic Drug Infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebos | Drug | IV Saline infusion for 2 hours. |
| |
| Propofol 0.45mcg/mL |
| Measure | Description | Time Frame |
|---|---|---|
| GSR Trial 1 | Galvanic skin repose (GSR) to the first habituation trial (yes/no). Coding: Yes (0) and No (1) | First Trial, for up to 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kane Pryor, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medical College/New York Presbyterian Hospital | New York | New York | 10065 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebos | Saline Infusion Placebos: IV Saline infusion for 2 hours. |
| FG001 | Propofol 0.45mcg/mL | Anesthetic Drug Infusion Propofol 0.45mcg/mL: IV Propofol infusion for 2 hours. |
| FG002 | Propofol 0.9mcg/mL | Anesthetic Drug Infusion Propofol 0.9mcg/mL: IV Propofol infusion for 2 hours. |
| FG003 | Thiopental 1.5mcg/mL | Anesthetic Drug Infusion Thiopental 1.5mcg/mL: IV Thiopental infusion for 2 hours. |
| FG004 | Thiopental 3mcg/mL | Anesthetic Drug Infusion Thiopental 3mcg/mL: IV Thiopental Infusion for 2 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebos | Saline Infusion Placebos: IV Saline infusion for 2 hours. |
| BG001 | Propofol 0.45mcg/mL | Anesthetic Drug Infusion Propofol 0.45mcg/mL: IV Propofol infusion for 2 hours. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | GSR Trial 1 | Galvanic skin repose (GSR) to the first habituation trial (yes/no). Coding: Yes (0) and No (1) | Posted | Mean | Standard Deviation | units on a scale | First Trial, for up to 1 day |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebos | Saline Infusion Placebos: IV Saline infusion for 2 hours. | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Extreme Fidgety | General disorders | Non-systematic Assessment | Extremely fidgety, dosing on and off, requiring prompting |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kane Pryor | Weill Cornell Medicine | (212) 746-2969 | kap9009@med.cornell.edu |
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| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D013874 | Thiopental |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
IV Propofol infusion for 2 hours. |
|
|
| Propofol 0.90mcg/mL | Drug | IV Propofol infusion for 2 hours. |
|
|
| Thiopental 1.5mcg/mL | Drug | IV Thiopental 1.5mcg/mL infusion for 2 hours |
|
|
| Thiopental 3mcg/mL | Drug | IV Thiopental 3mcg/mL infusion for 2 hours |
|
|
| BG002 | Propofol 0.9mcg/mL | Anesthetic Drug Infusion Propofol 0.9mcg/mL: IV Propfol infusion for 2 hours. |
| BG003 | Thiopental 1.5mcg/mL | Anesthetic Drug Infusion Thiopental 1.5mcg/mL: IV Thiopental infusion for 2 hours. |
| BG004 | Thiopental 3mcg/mL | Anesthetic Drug Infusion Thiopental 3mcg/mL: IV Thiopental Infusion for 2 hours. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG003 | Thiopental 1.5mcg/mL | Anesthetic Drug Infusion Thiopental 1.5mcg/mL: IV Thiopental infusion for 2 hours. |
| OG004 | Thiopental 3mcg/mL | Anesthetic Drug Infusion Thiopental 3mcg/mL: IV Thiopental Infusion for 2 hours. |
|
|
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Propofol 0.45mcg/mL | Anesthetic Drug Infusion Propofol 0.45mcg/mL: IV Propofol infusion for 2 hours. | 0 | 20 | 0 | 20 | 1 | 20 |
| EG002 | Propofol 0.90mcg/mL | Anesthetic Drug Infusion Propofol 0.90mcg/mL: IV Propofol infusion for 2 hours. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG003 | Thiopental 1.5mcg/mL | Anesthetic Drug Infusion Thiopental 1.5mcg/mL: IV Thiopental 1.5mcg/mL infusion for 2 hours | 0 | 3 | 0 | 3 | 0 | 3 |
| EG004 | Thiopental 3mcg/mL | Anesthetic Drug Infusion Thiopental 3mcg/mL: IV Thiopental 3mcg/mL infusion for 2 hours | 0 | 3 | 0 | 3 | 0 | 3 |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013858 | Thiobarbiturates |
| D001463 | Barbiturates |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |