Actively Recruiting
The Effects of Propranolol and Hydrocortisone on Military-Relevant Performance Outcomes
Led by Walter Reed Army Institute of Research (WRAIR) · Updated on 2026-05-13
88
Participants Needed
1
Research Sites
66 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial aims to evaluate the nature and duration of effects of three FDA-approved medications (propranolol and hydrocortisone) 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? Participants will receive one of five study medications (oral propranolol, oral placebo, IM hydrocortisone, or IM placebo) 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.
CONDITIONS
Official Title
The Effects of Propranolol and Hydrocortisone on Military-Relevant Performance Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and non-pregnant, non-lactating females 18 to 40 (inclusive) years of age.
- Females of child-bearing potential must use birth control if sexually active.
- Score 80% or greater on a Volunteer Comprehension Assessment.
- Score 54 or higher on the Fear of Spiders Questionnaire.
- Body weight between 91 and 250 pounds (inclusive).
- Live close enough to commute to Walter Reed Army Institute of Research during study participation.
You will not qualify if you...
- Allergic or hypersensitivity reactions to beta blockers or steroids.
- History of allergic reactions to spider bites.
- History or suspected abuse/addiction to illicit drugs or prescribed medications.
- Use of nicotine products more than 3 days per week.
- Self-reported caffeine use exceeding 600 mg per day or inability to abstain during visits.
- History of neurological disorders like epilepsy, MS, or severe brain injury unless mild and resolved.
- Beck Depression Inventory score 10 or above or suicidal thoughts.
- High anxiety or PTSD scores above specified thresholds.
- History of cardiovascular or pulmonary diseases affecting oxygenation.
- Night shift work or irregular sleep schedule incompatible with study sleep requirements.
- Diagnosed sleep apnea.
- Kidney, liver, or metabolic diseases affecting neurophysiological function.
- Recent hospitalization for psychiatric disorders or unstable psychiatric symptoms.
- Current use of antipsychotics, anticonvulsants, mood stabilizers, CNS depressants, or unsafe medications.
- Heavy alcohol use exceeding defined limits.
- Positive pregnancy or breastfeeding status in females.
- Resting blood pressure above 140/90 or below 100/60 with exceptions.
- BMI 31 or higher, with discretion for BMI 30-31.
- Clinically significant hematology or chemistry abnormalities.
- Recent immunotherapy or vaccination within 30 days before enrollment.
- Positive drug or alcohol tests during study visits.
- Inability to consent or cooperate, lack of emergency contacts.
- Current use of illicit drugs or medications interacting adversely with study drugs.
- Current diabetes or gastrointestinal motility disorders.
- Failure to provide required identification for study payment.
- Participation in another ongoing clinical trial.
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Trial Site Locations
Total: 1 location
1
Sleep Research Center (SRC), Walter Reed Army Institute of Research
Silver Spring, Maryland, United States, 20910
Actively Recruiting
Research Team
J
John Hughes, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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