- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00767767
The Effect of Intravenous Anesthetics on Fear Learning and Memory
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Weill Cornell Medical College/New York Presbyterian Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age between 18 and 50
- minimum of high school education
- fluent in English
- normal vocabulary
Exclusion Criteria:
- any significant medical or psychiatric comorbidity (e.g. asthma, diabetes, hypertension, depression, high anxiety)--subjects must be in excellent health such that they would be classified as American Society of Anesthesiologists Physical Status Class I
- deficit in vision or hearing that would impede the study
- allergies to any of the study drugs, to soybeans, or to eggs
- a history of head trauma
- a family history of major psychiatric illness
- body mass index > 30 kg/m2
- a recent history of recreational drug use
- prior exposure to the study materials
- pregnancy
- a personal or family history of any porphyria
- failure to exhibit a skin conductance response to deep inspiration
- the ability to read Chinese characters
- assessment by the investigators that the subject may be unable to cooperate or comply with the study requirements.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebos
Saline Infusion
|
IV Saline infusion for 2 hours.
|
Active Comparator: Propofol 0.45mcg/mL
Anesthetic Drug Infusion
|
IV Propofol infusion for 2 hours.
Other Names:
|
Active Comparator: Propofol 0.90mcg/mL
Anesthetic Drug Infusion
|
IV Propofol infusion for 2 hours.
Other Names:
|
Active Comparator: Thiopental 1.5mcg/mL
Anesthetic Drug Infusion
|
IV Thiopental 1.5mcg/mL infusion for 2 hours
Other Names:
|
Active Comparator: Thiopental 3mcg/mL
Anesthetic Drug Infusion
|
IV Thiopental 3mcg/mL infusion for 2 hours
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GSR Trial 1
Time Frame: First Trial, for up to 1 day
|
Galvanic skin repose (GSR) to the first habituation trial (yes/no).
Coding: Yes (0) and No (1)
|
First Trial, for up to 1 day
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kane Pryor, MD, Weill Medical College of Cornell University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0710009434
- K08GM083213 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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