Developing Anesthesia as Post Traumatic Stress Disorder (PTSD) Therapy
Developing Anesthesia as PTSD Therapy
2 other identifiers
interventional
293
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Sep 2009
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 16, 2012
CompletedFirst Posted
Study publicly available on registry
November 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedOctober 13, 2016
October 1, 2016
7.6 years
November 16, 2012
October 12, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Number of events remembered
The proportion of items remembered in long-term memory 4 days after viewing emotional or neutral pictures.
Day 4
Secondary Outcomes (1)
Event-related fMRI BOLD signals
Baseline
Other Outcomes (1)
Tolerability
Baseline
Study Arms (5)
Placebo
PLACEBO COMPARATORPlacebo
Dexmedetomidine
EXPERIMENTALDexmedetomidine intravenous infusion during scan.
Propofol
EXPERIMENTALPropofol intravenous infusion during scan.
Ketamine
EXPERIMENTALKetamine intravenous infusion during scan.
Nitrous Oxide
EXPERIMENTALNitrous Oxide inhalation during scan.
Interventions
A low dose of dexmedetomidine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
A low dose of propofol is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
A low dose of ketamine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
A low dose of nitrous oxide is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
Eligibility Criteria
You may qualify if:
- Healthy adults.
- Between the ages of 18 and 35.
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, Irvine
Irvine, California, 92697, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael T Alkire, MD
University of California, Irvine and Long Beach VA Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 16, 2012
First Posted
November 29, 2012
Study Start
September 1, 2009
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
October 13, 2016
Record last verified: 2016-10