Developing Anesthesia as Post Traumatic Stress Disorder (PTSD) Therapy

Ketamine

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.

Intervention / Treatment

  • Dexmedetomidine (DRUG)
    A low dose of dexmedetomidine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
  • Propofol (DRUG)
    A low dose of propofol is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
  • Ketamine (DRUG)
    A low dose of ketamine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
  • Nitrous Oxide (DRUG)
    A low dose of nitrous oxide is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
  • Placebo (DRUG)

Condition or Disease

  • Healthy

Phase

  • Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 18 Years to 35 Years
    Enrollment: 293 (ACTUAL)
    Funded by: Other|NIH
    Allocation: Non-Randomized
    Primary Purpose: Basic Science

    Masking

    SINGLE:
    • Participant

    Clinical Trial Dates

    Start date: Sep 01, 2009
    Primary Completion: Apr 01, 2017 ESTIMATED
    Completion Date: Apr 01, 2017 ESTIMATED
    Study First Posted: Nov 29, 2012 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Oct 12, 2016

    Sponsors / Collaborators

    Lead Sponsor: Southern California Institute for Research and Education
    Responsible Party: N/A

    Location

    Irvine, California, USA

    Participant Groups

    • Placebo

    • Dexmedetomidine intravenous infusion during scan.

    • Propofol intravenous infusion during scan.

    • Ketamine intravenous infusion during scan.

    • Nitrous Oxide inhalation during scan.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 35
    Age Groups: Adult
    Healthy Volunteers: Yes

    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.

    Primary Outcomes

    • The proportion of items remembered in long-term memory 4 days after viewing emotional or neutral pictures.

    Secondary Outcomes

    • Evoked fMRI responses to emotional and neutral pictures are measured and later correlated with subsequent memory performance.

    Other Outcomes

    • Subjective and objective measures of subject responses to the various agents are noted.

    More Details

    NCT Number: NCT01736020
    Other IDs: MIRB 1007, UCI 2004-3707
    Study URL: https://clinicaltrials.gov/study/NCT01736020
    Last updated: Sep 29, 2023