Overview

This trial is active, not recruiting.

Condition healthy
Treatments dexmedetomidine, propofol, ketamine, nitrous oxide, placebo
Phase phase 1
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose basic science
Arm
(Placebo Comparator)
Placebo
dexmedetomidine
A low dose of dexmedetomidine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
propofol
A low dose of propofol is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
ketamine
A low dose of ketamine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
nitrous oxide
A low dose of nitrous oxide is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
placebo
Placebo
(Experimental)
Dexmedetomidine intravenous infusion during scan.
dexmedetomidine
A low dose of dexmedetomidine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
(Experimental)
Propofol intravenous infusion during scan.
propofol
A low dose of propofol is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
(Experimental)
Ketamine intravenous infusion during scan.
ketamine
A low dose of ketamine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
(Experimental)
Nitrous Oxide inhalation during scan.
nitrous oxide
A low dose of nitrous oxide is used during scanning after dose piloting outside the scanner for memory effects and tolerability.

Primary Outcomes

Measure
Number of events remembered
time frame: Day 4

Secondary Outcomes

Measure
Event-related fMRI BOLD signals
time frame: Baseline

Eligibility Criteria

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.

Additional Information

Official title Developing Anesthesia as PTSD Therapy
Principal investigator Michael T Alkire, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Southern California Institute for Research and Education.