Healthy
Conditions
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.
Interventions
DRUGDexmedetomidine
A low dose of dexmedetomidine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
DRUGPropofol
A low dose of propofol is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
DRUGKetamine
A low dose of ketamine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
DRUGNitrous Oxide
A low dose of nitrous oxide is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
DRUGPlacebo
Placebo
Sponsors
National Institute of Mental Health (NIMH)
University of California, Irvine
Southern California Institute for Research and Education
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of events remembered | Day 4 | The proportion of items remembered in long-term memory 4 days after viewing emotional or neutral pictures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Event-related fMRI BOLD signals | Baseline | Evoked fMRI responses to emotional and neutral pictures are measured and later correlated with subsequent memory performance. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tolerability | Baseline | Subjective and objective measures of subject responses to the various agents are noted. |
Countries
United States
Outcome results
None listed