Developing Anesthesia as Post Traumatic Stress Disorder (PTSD) Therapy

Healthy Clinical Trial

Official title:

Developing Anesthesia as PTSD Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01736020
• Other study ID #: MIRB 1007, UCI 2004-3707
• Secondary ID: R34MH087390
• Status: Active, not recruiting
• Phase: Phase 1
• First received: November 16, 2012
• Last updated: October 12, 2016
• Start date: September 2009
• Est. completion date: April 2017

Study information

• Verified date: October 2016
• Source: Southern California Institute for Research and Education
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 293
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy
• Stress Disorders, Post-Traumatic

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	University of California, Irvine	Irvine	California

Sponsors (3)

Lead Sponsor	Collaborator
Southern California Institute for Research and Education	National Institute of Mental Health (NIMH), University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tolerability	Subjective and objective measures of subject responses to the various agents are noted.	Baseline	Yes
Primary	Number of events remembered	The proportion of items remembered in long-term memory 4 days after viewing emotional or neutral pictures.	Day 4	No
Secondary	Event-related fMRI BOLD signals	Evoked fMRI responses to emotional and neutral pictures are measured and later correlated with subsequent memory performance.	Baseline	No