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| Sponsor: | Weill Medical College of Cornell University |
|---|---|
| Collaborators: |
National Institutes of Health (NIH) National Institute of General Medical Sciences (NIGMS) |
| Information provided by (Responsible Party): | Kane Pryor, Weill Medical College of Cornell University |
| ClinicalTrials.gov Identifier: | NCT00767767 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Phobias |
Drug: Propofol Drug: Placebo Drug: Thiopental Drug: Midazolam Drug: Dexmedetomidine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
| Official Title: | The Effect of Intravenous Anesthetics on Fear Learning and Memory |
| Estimated Enrollment: | 90 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | December 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Saline Infusion.
|
Drug: Placebo
IV Saline infusion for 2 hours.
|
|
Active Comparator: 2
Anesthetic Drug Infusion.
|
Drug: Propofol
IV Propofol infusion for 2 hours.
Drug: Thiopental
IV Thiopental infusion for 2 hours.
Drug: Midazolam
IV Midazolam infusion for 2 hours.
Drug: Dexmedetomidine
IV Dexmedetomidine Infusion for 2 hours.
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Weill Cornell Medical College/New York Presbyterian Hospital | |
| New York, New York, United States, 10065 | |
| Principal Investigator: | Kane Pryor, MD | Weill Medical College of Cornell University |
More Information
| Responsible Party: | Kane Pryor, Director of Clinical Research, Anesthesiology, Weill Medical College of Cornell University |
| ClinicalTrials.gov Identifier: | NCT00767767 History of Changes |
| Other Study ID Numbers: | 0710009434, K08GM083213 |
| Study First Received: | October 3, 2008 |
| Last Updated: | September 28, 2011 |
| Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
|
To investigate the effects of anesthetic drugs on associative memory processes involving fear |
|
Phobic Disorders Anxiety Disorders Mental Disorders Anesthetics Midazolam Propofol Thiopental Dexmedetomidine Anesthetics, Intravenous Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Adjuvants, Anesthesia |
Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs Hypnotics and Sedatives Anesthetics, General GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anticonvulsants Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists |