NCT00767767

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

April 10, 2017

Completed
Last Updated

May 15, 2019

Status Verified

April 1, 2019

Enrollment Period

2.6 years

First QC Date

October 3, 2008

Results QC Date

February 24, 2017

Last Update Submit

April 30, 2019

Conditions

Keywords

anesthetic drugs, associative memory, fear

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (5)

Placebos

PLACEBO COMPARATOR

Saline Infusion

Drug: Placebos

Propofol 0.45mcg/mL

ACTIVE COMPARATOR

Anesthetic Drug Infusion

Drug: Propofol 0.45mcg/mL

Propofol 0.90mcg/mL

ACTIVE COMPARATOR

Anesthetic Drug Infusion

Drug: Propofol 0.90mcg/mL

Thiopental 1.5mcg/mL

ACTIVE COMPARATOR

Anesthetic Drug Infusion

Drug: Thiopental 1.5mcg/mL

Thiopental 3mcg/mL

ACTIVE COMPARATOR

Anesthetic Drug Infusion

Drug: Thiopental 3mcg/mL

Interventions

IV Saline infusion for 2 hours.

Placebos

IV Propofol infusion for 2 hours.

Also known as: Propofol
Propofol 0.45mcg/mL

IV Propofol infusion for 2 hours.

Also known as: Propofol
Propofol 0.90mcg/mL

IV Thiopental 1.5mcg/mL infusion for 2 hours

Also known as: Thiopental
Thiopental 1.5mcg/mL

IV Thiopental 3mcg/mL infusion for 2 hours

Also known as: Thiopental
Thiopental 3mcg/mL

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age between 18 and 50
  • minimum of high school education
  • fluent in English
  • normal vocabulary

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medical College/New York Presbyterian Hospital

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Phobic Disorders

Interventions

PropofolThiopental

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsThiobarbituratesBarbituratesPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Kane Pryor
Organization
Weill Cornell Medicine

Study Officials

  • Kane Pryor, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2008

First Posted

October 7, 2008

Study Start

October 1, 2008

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 15, 2019

Results First Posted

April 10, 2017

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations