Developing Anesthesia as Post Traumatic Stress Disorder (PTSD) Therapy

This study is currently recruiting participants.
Verified November 2012 by Southern California Institute for Research and Education
Sponsor:
Collaborators:
University of California, Irvine
Information provided by (Responsible Party):
Michael Alkire, Southern California Institute for Research and Education
ClinicalTrials.gov Identifier:
NCT01736020
First received: November 16, 2012
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Dexmedetomidine
Drug: Propofol
Drug: Ketamine
Drug: Nitrous Oxide
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Developing Anesthesia as PTSD Therapy

Resource links provided by NLM:


Further study details as provided by Southern California Institute for Research and Education:

Primary Outcome Measures:
  • Number of events remembered [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
    The proportion of items remembered in long-term memory 4 days after viewing emotional or neutral pictures.


Secondary Outcome Measures:
  • Event-related fMRI BOLD signals [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Evoked fMRI responses to emotional and neutral pictures are measured and later correlated with subsequent memory performance.


Other Outcome Measures:
  • Tolerability [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Subjective and objective measures of subject responses to the various agents are noted.


Estimated Enrollment: 315
Study Start Date: September 2009
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Experimental: Dexmedetomidine
Dexmedetomidine intravenous infusion during scan.
Drug: Dexmedetomidine
A low dose of dexmedetomidine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
Experimental: Propofol
Propofol intravenous infusion during scan.
Drug: Propofol
A low dose of propofol is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
Experimental: Ketamine
Ketamine intravenous infusion during scan.
Drug: Ketamine
A low dose of ketamine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
Experimental: Nitrous Oxide
Nitrous Oxide inhalation during scan.
Drug: Nitrous Oxide
A low dose of nitrous oxide is used during scanning after dose piloting outside the scanner for memory effects and tolerability.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736020

Contacts
Contact: Michael T Alkire, MD 949 824 6128 malkire@uci.edu
Contact: Hiroki Hayama, PhD 949 824 6128 hhayama@gmail.com

Locations
United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92697
Principal Investigator: Michael T Alkire, MD         
Sponsors and Collaborators
Southern California Institute for Research and Education
University of California, Irvine
Investigators
Principal Investigator: Michael T Alkire, MD University of California, Irvine and Long Beach VA Medical Center
  More Information

No publications provided

Responsible Party: Michael Alkire, Associate Professor, Southern California Institute for Research and Education
ClinicalTrials.gov Identifier: NCT01736020     History of Changes
Other Study ID Numbers: MIRB 1007, UCI 2004-3707, R34MH087390
Study First Received: November 16, 2012
Last Updated: November 27, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Anesthetics
Ketamine
Nitrous Oxide
Propofol
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Anesthetics, Inhalation
Hypnotics and Sedatives
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists

ClinicalTrials.gov processed this record on April 17, 2014