Developing Anesthesia as Post Traumatic Stress Disorder (PTSD) Therapy
This trial is active, not recruiting.
|Treatments||dexmedetomidine, propofol, ketamine, nitrous oxide, placebo|
|Sponsor||Southern California Institute for Research and Education|
|Collaborator||National Institute of Mental Health (NIMH)|
|Start date||September 2009|
|End date||April 2017|
|Trial size||293 participants|
|Trial identifier||NCT01736020, MIRB 1007, UCI 2004-3707, R34MH087390|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
|Primary purpose||basic science|
Number of events remembered
time frame: Day 4
Event-related fMRI BOLD signals
time frame: Baseline
Male or female participants from 18 years up to 35 years old.
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.
|Official title||Developing Anesthesia as PTSD Therapy|
|Principal investigator||Michael T Alkire, MD|
Call for more information