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Developing Anesthesia as Post Traumatic Stress Disorder (PTSD) Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01736020
Recruitment Status : Unknown
Verified October 2016 by Michael Alkire, Southern California Institute for Research and Education.
Recruitment status was:  Active, not recruiting
First Posted : November 29, 2012
Last Update Posted : October 13, 2016
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of California, Irvine
Information provided by (Responsible Party):
Michael Alkire, Southern California Institute for Research and Education

Tracking Information
First Submitted Date  ICMJE November 16, 2012
First Posted Date  ICMJE November 29, 2012
Last Update Posted Date October 13, 2016
Study Start Date  ICMJE September 2009
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2012)
Number of events remembered [ Time Frame: Day 4 ]
The proportion of items remembered in long-term memory 4 days after viewing emotional or neutral pictures.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2012)
Event-related fMRI BOLD signals [ Time Frame: Baseline ]
Evoked fMRI responses to emotional and neutral pictures are measured and later correlated with subsequent memory performance.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 27, 2012)
Tolerability [ Time Frame: Baseline ]
Subjective and objective measures of subject responses to the various agents are noted.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Developing Anesthesia as Post Traumatic Stress Disorder (PTSD) Therapy
Official Title  ICMJE Developing Anesthesia as PTSD Therapy
Brief Summary 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Dexmedetomidine
    A low dose of dexmedetomidine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
  • Drug: Propofol
    A low dose of propofol is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
  • Drug: Ketamine
    A low dose of ketamine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
  • Drug: Nitrous Oxide
    A low dose of nitrous oxide is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo
    Interventions:
    • Drug: Dexmedetomidine
    • Drug: Propofol
    • Drug: Ketamine
    • Drug: Nitrous Oxide
    • Drug: Placebo
  • Experimental: Dexmedetomidine
    Dexmedetomidine intravenous infusion during scan.
    Intervention: Drug: Dexmedetomidine
  • Experimental: Propofol
    Propofol intravenous infusion during scan.
    Intervention: Drug: Propofol
  • Experimental: Ketamine
    Ketamine intravenous infusion during scan.
    Intervention: Drug: Ketamine
  • Experimental: Nitrous Oxide
    Nitrous Oxide inhalation during scan.
    Intervention: Drug: Nitrous Oxide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: October 12, 2016)
293
Original Estimated Enrollment  ICMJE
 (submitted: November 27, 2012)
315
Estimated Study Completion Date  ICMJE April 2017
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01736020
Other Study ID Numbers  ICMJE MIRB 1007, UCI 2004-3707
R34MH087390 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Alkire, Southern California Institute for Research and Education
Study Sponsor  ICMJE Southern California Institute for Research and Education
Collaborators  ICMJE
  • National Institute of Mental Health (NIMH)
  • University of California, Irvine
Investigators  ICMJE
Principal Investigator: Michael T Alkire, MD University of California, Irvine and Long Beach VA Medical Center
PRS Account Southern California Institute for Research and Education
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP