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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00767767
Other study ID # 0710009434
Secondary ID K08GM083213
Status Completed
Phase N/A
First received
Last updated
Start date October 2008
Est. completion date May 2011

Study information

Verified date April 2019
Source Weill Medical College of Cornell University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Placebos
IV Saline infusion for 2 hours.
Propofol 0.45mcg/mL
IV Propofol infusion for 2 hours.
Propofol 0.90mcg/mL
IV Propofol infusion for 2 hours.
Thiopental 1.5mcg/mL
IV Thiopental 1.5mcg/mL infusion for 2 hours
Thiopental 3mcg/mL
IV Thiopental 3mcg/mL infusion for 2 hours

Locations

Country Name City State
United States Weill Cornell Medical College/New York Presbyterian Hospital New York New York

Sponsors (3)

Lead Sponsor Collaborator
Weill Medical College of Cornell University National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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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