Developing Anesthesia as Post Traumatic Stress Disorder (PTSD) Therapy

• ClinicalTrials.gov Identifier: NCT01736020
• Recruitment Status: Unknown
• First Posted: November 29, 2012
• Last Update Posted: October 13, 2016
• Sponsor: Southern California Institute for Research and Education
• Collaborators: National Institute of Mental Health (NIMH); University of California, Irvine
• Information provided by (Responsible Party): Michael Alkire, Southern California Institute for Research and Education

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Dexmedetomidine; Drug: Propofol; Drug: Ketamine; Drug: Nitrous Oxide; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 293 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Developing Anesthesia as PTSD Therapy
• Study Start Date: September 2009
• Estimated Primary Completion Date: April 2017
• Estimated Study Completion Date: April 2017

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Placebo	Drug: Dexmedetomidine; A low dose of dexmedetomidine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.; Drug: Propofol; A low dose of propofol is used during scanning after dose piloting outside the scanner for memory effects and tolerability.; Drug: Ketamine; A low dose of ketamine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.; Drug: Nitrous Oxide; A low dose of nitrous oxide is used during scanning after dose piloting outside the scanner for memory effects and tolerability.; Drug: Placebo; Placebo
Experimental: Dexmedetomidine; Dexmedetomidine intravenous infusion during scan.	Drug: Dexmedetomidine; A low dose of dexmedetomidine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
Experimental: Propofol; Propofol intravenous infusion during scan.	Drug: Propofol; A low dose of propofol is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
Experimental: Ketamine; Ketamine intravenous infusion during scan.	Drug: Ketamine; A low dose of ketamine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
Experimental: Nitrous Oxide; Nitrous Oxide inhalation during scan.	Drug: Nitrous Oxide; A low dose of nitrous oxide is used during scanning after dose piloting outside the scanner for memory effects and tolerability.

Outcome Measures

Primary Outcome Measures :

1. Number of events remembered [ Time Frame: Day 4 ]
   The proportion of items remembered in long-term memory 4 days after viewing emotional or neutral pictures.

Secondary Outcome Measures :

1. Event-related fMRI BOLD signals [ Time Frame: Baseline ]
   Evoked fMRI responses to emotional and neutral pictures are measured and later correlated with subsequent memory performance.

Other Outcome Measures:

1. Tolerability [ Time Frame: Baseline ]
   Subjective and objective measures of subject responses to the various agents are noted.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, California

University of California, Irvine

Irvine, California, United States, 92697

Sponsors and Collaborators

Southern California Institute for Research and Education

National Institute of Mental Health (NIMH)

University of California, Irvine

Investigators

• Principal Investigator: Michael T Alkire, MD; University of California, Irvine and Long Beach VA Medical Center

More Information

• Responsible Party: Michael Alkire, Associate Professor, Southern California Institute for Research and Education
• ClinicalTrials.gov Identifier: NCT01736020
• Other Study ID Numbers: MIRB 1007, UCI 2004-3707; R34MH087390 ( U.S. NIH Grant/Contract )
• First Posted: November 29, 2012
• Last Update Posted: October 13, 2016
• Last Verified: October 2016

Additional relevant MeSH terms:

Dexmedetomidine; Nitrous Oxide; Ketamine; Propofol; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anesthetics, Dissociative; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Anesthetics, Inhalation