Developing Anesthesia as Post Traumatic Stress Disorder (PTSD) Therapy

NCT ID: NCT01736020

Last Updated: 2016-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

293 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2017-04-30

Brief Summary

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This preclinical phase 1 development study in healthy volunteers seeks to identify if low doses of commonly used non-triggering anesthetic agents might have clinical utility for modulating emotional memory processing and to understand the nature of the brain mechanisms of drug action. Optimally, a drug, dose and brain mechanism of action will be identified that will form the foundation for future use in clinical studies of patients with PTSD.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

A low dose of dexmedetomidine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.

Propofol

Intervention Type DRUG

A low dose of propofol is used during scanning after dose piloting outside the scanner for memory effects and tolerability.

Ketamine

Intervention Type DRUG

A low dose of ketamine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.

Nitrous Oxide

Intervention Type DRUG

A low dose of nitrous oxide is used during scanning after dose piloting outside the scanner for memory effects and tolerability.

Placebo

Intervention Type DRUG

Placebo

Dexmedetomidine

Dexmedetomidine intravenous infusion during scan.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

A low dose of dexmedetomidine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.

Propofol

Propofol intravenous infusion during scan.

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

A low dose of propofol is used during scanning after dose piloting outside the scanner for memory effects and tolerability.

Ketamine

Ketamine intravenous infusion during scan.

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

A low dose of ketamine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.

Nitrous Oxide

Nitrous Oxide inhalation during scan.

Group Type EXPERIMENTAL

Nitrous Oxide

Intervention Type DRUG

A low dose of nitrous oxide is used during scanning after dose piloting outside the scanner for memory effects and tolerability.

Interventions

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Dexmedetomidine

A low dose of dexmedetomidine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.

Intervention Type DRUG

Propofol

A low dose of propofol is used during scanning after dose piloting outside the scanner for memory effects and tolerability.

Intervention Type DRUG

Ketamine

A low dose of ketamine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.

Intervention Type DRUG

Nitrous Oxide

A low dose of nitrous oxide is used during scanning after dose piloting outside the scanner for memory effects and tolerability.

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adults.
* Between the ages of 18 and 35.

Exclusion Criteria

* Pregnancy.
* Left-handed.
* Unusual facial anatomy.
* History of esophageal reflux.
* Respiratory problems.
* Central nervous system disorders.
* Cardiovascular problems.
* Kidney disease.
* Diabetes.
* History of Substance abuse.
* History of adverse anesthetic reactions.
* Hepatitis.
* Failure to pass MRI screening questionnaire.
* Fear of small-enclosed spaces.
* Mental illness.
* Non-native English speakers.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role collaborator

Southern California Institute for Research and Education

OTHER

Sponsor Role lead

Responsible Party

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Michael Alkire

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael T Alkire, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine and Long Beach VA Medical Center

Locations

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University of California, Irvine

Irvine, California, United States

Site Status

Countries

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United States

Other Identifiers

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R34MH087390

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MIRB 1007, UCI 2004-3707

Identifier Type: -

Identifier Source: org_study_id

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