The Effects of Propranolol, Hydrocortisone, and Morphine on Military-Relevant Performance Outcomes: A Randomized, Blinded, Placebo Controlled Study
Walter Reed Army Institute of Research (WRAIR)
Summary
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.
Eligibility
- Age range
- 18–40 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male and non-pregnant, non-lactating females 18 to 40 (inclusive) years of age. * Females of child-bearing potential must be on some form of birth control, if sexually active (e.g., oral contraceptive, condom, intrauterine device, etc.) * Score of 80% or greater on a "Volunteer Comprehension Assessment" test. * Score equal to or greater than 54 on the Fear of Spiders Questionnaire. * Body weight between 91 and 250 pounds (inclusive). * Live close enough to be able to commute to Walter Reed Army Institute of Research during the study participation. Exclusion Criteria: *…
Interventions
- DrugPropranolol
An administration of a 40-mg propranolol capsule immediately after tarantula exposure
- DrugHydrocortisone
An intramuscular administration of 62.5 mg/1 ml of hydrocortisone immediately after tarantula exposure
- DrugMorphine
An intramuscular administration of 5 mg/1 ml of morphine immediately after tarantula exposure
- DrugPlacebo (oral)
An administration of a placebo capsule after tarantula exposure
- DrugPlacebo (IM)
An intramuscular administration of 1 ml of saline immediately after tarantula exposure
Location
- Sleep Research Center (SRC), Walter Reed Army Institute of ResearchSilver Spring, Maryland