Developing Anesthesia as Post Traumatic Stress Disorder (PTSD) Therapy

Phase 1

• Conditions: Healthy
• Interventions: Drug: Dexmedetomidine; Drug: Propofol; Drug: Ketamine; Drug: Nitrous Oxide; Drug: Placebo

• Registration Number: NCT01736020
• Lead Sponsor: Southern California Institute for Research and Education

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 available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2012-11-16
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-29
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-13
• Primary Completion: 2017-04
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 293

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Ketamine	Placebo
Placebo	Placebo	Placebo
Placebo	Dexmedetomidine	Placebo
Placebo	Nitrous Oxide	Placebo
Placebo	Propofol	Placebo
Dexmedetomidine	Dexmedetomidine	Dexmedetomidine intravenous infusion during scan.
Propofol	Propofol	Propofol intravenous infusion during scan.
Nitrous Oxide	Nitrous Oxide	Nitrous Oxide inhalation during scan.
Ketamine	Ketamine	Ketamine intravenous infusion during scan.

Primary Outcome Measures

Name	Time	Method
Number of events remembered	Day 4	The proportion of items remembered in long-term memory 4 days after viewing emotional or neutral pictures.

Secondary Outcome Measures

Name	Time	Method
Event-related fMRI BOLD signals	Baseline	Evoked fMRI responses to emotional and neutral pictures are measured and later correlated with subsequent memory performance.

Trial Locations

Locations (1)

University of California, Irvine; 🇺🇸 Irvine, California, United States