This clinical trial aims to evaluate the nature and duration of effects of three FDA-approved medications (propranolol, hydrocortisone, and morphine) on military-relevant cognitive, emotional, and motor performance following an exposure to a stressful situation (i.e., exposure to a tarantula) in physically healthy adult volunteers (aged 18 - 40) with fear of spiders to help the future development of medications for treating Acute Stress Reactions. The main questions this study aims to answer are: Will placebo treatment (oral placebo) result in significant decrements in Psychomotor Vigilance Task (PVT) performance compared to propranolol treatment? Will placebo treatment \[intramuscular (IM) placebo\] result in significant decrements in PVT performance compared to hydrocortisone treatment? Will placebo treatment (IM placebo) result in significant decrements in PVT performance compared to morphine treatment? Participants will receive one of five study medications (oral propranolol, oral placebo, IM hydrocortisone, IM morphine, or IM morphine) after a brief exposure to a tarantula. Participants will complete cognitive and simple motor tasks and psychological assessments before and after the study medication administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
110
An administration of a 40-mg propranolol capsule immediately after tarantula exposure
An intramuscular administration of 62.5 mg/1 ml of hydrocortisone immediately after tarantula exposure
An intramuscular administration of 5 mg/1 ml of morphine immediately after tarantula exposure
An administration of a placebo capsule after tarantula exposure
An intramuscular administration of 1 ml of saline immediately after tarantula exposure
Sleep Research Center (SRC), Walter Reed Army Institute of Research
Silver Spring, Maryland, United States
RECRUITINGPsychomotor Vigilance Task
Measure of cognitive performance. Reaction time (millisecond)
Time frame: Baseline and post-treatment time points within approximately 25 hours following the study medication administration.
Behavioral Approach Task
An behavioral assessment to examine how closely individuals can approach an aversive stimulus.
Time frame: Baseline and approximately 24 hours post-treatment.
Go/No-Go task
Measure of cognitive performance.
Time frame: Baseline and post-treatment time points within approximately 25 hours following the study medication administration.
Matching to Sample task
Measure of cognitive performance
Time frame: Baseline and post-treatment time points within approximately 25 hours following the study medication administration.
Simple Reaction Time task
Measure of cognitive performance.
Time frame: Baseline and post-treatment time points within approximately 25 hours following the study medication administration.
The Automated Neuropsychological Assessment Metrics (ANAM) Mood Scale
Measure of mood.
Time frame: Baseline and post-treatment time points within approximately 25 hours following the study medication administration.
WRAIR Mood Battery
A short battery of measures of various aspects of mood.
Time frame: Baseline and post-treatment time points within approximately 25 hours following the study medication administration.
Heart rate
Continuous measure of heart rate.
Time frame: Before, during, and after behavioral approach task and aversive stimulus exposure. 30 minutes - 1 hour at each time point.
Biosway
Measure of motor performance
Time frame: Baseline and post-treatment time points within approximately 25 hours following the study medication administration.
Triple Hop Test
Measure of motor performance.
Time frame: Baseline and post-treatment time points within approximately 25 hours following the study medication administration.
Drug Effects Questionnaire
Measure of subjective response to a substance.
Time frame: Multiple time points within approximately 25 hours following the study medication administration.
Subjective Fear Scale
Subjective measure of fear. A 0 - 100 numerical scale.
Time frame: Baseline, during the behavioral approach test and aversive stimulus exposure, and time points within approximately 25 hours after the study medication administration.
Subjective Anxiety Scale
Subjective measure of anxiety. A 0 - 100 numerical scale.
Time frame: Baseline, during the behavioral approach test and aversive stimulus exposure, and time points within approximately 25 hours after the study medication administration.
Subjective Stress Scale
Subjective measure of stress. A 0 - 100 numerical scale.
Time frame: Baseline, during the behavioral approach test and aversive stimulus exposure, and time points within approximately 25 hours after the study medication administration.
Symptom checklist
Checklist to capture adverse drug reactions.
Time frame: Baseline, pre-medication administration, and time points within approximately 27 hours after the medication administration.
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