Developing Anesthesia as Post Traumatic Stress Disorder (PTSD) Therapy

Southern California Institute for Research and Education

Status and phase: Unknown; Phase 1

Conditions: Healthy

Treatments: Drug: Propofol; Drug: Nitrous Oxide; Drug: Dexmedetomidine; Drug: Placebo; Drug: Ketamine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01736020

MIRB 1007, UCI 2004-3707

R34MH087390 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 293 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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293 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Nitrous Oxide

Drug: Propofol

Drug: Dexmedetomidine

Drug: Ketamine

Drug: Placebo

Dexmedetomidine

Experimental group

Description:

Dexmedetomidine intravenous infusion during scan.

Treatment:

Drug: Dexmedetomidine

Propofol

Experimental group

Description:

Propofol intravenous infusion during scan.

Treatment:

Drug: Propofol

Ketamine

Experimental group

Description:

Ketamine intravenous infusion during scan.

Treatment:

Drug: Ketamine

Nitrous Oxide

Experimental group

Description:

Nitrous Oxide inhalation during scan.

Treatment:

Drug: Nitrous Oxide