The Effects of Propranolol and Hydrocortisone on Military-Relevant Performance Outcomes
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-40
SponsorWalter Reed Army Institute of Research (WRAIR)
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Contraindications due to study medications, including a history of allergic/hypersensitivity reactions to a beta blocker or a steroid, or a history of other adverse reactions to these classes of drugs (such as an episode of steroid psychosis).
A history of allergic reactions to a spider bite.
A history of abuse or addiction to illicit drugs (including marijuana) or prescribed medication (e.g., opioid) (diagnosed or suspected based on the medical history).
Use a nicotine product (e.g., cigarette, cigar, vape) more than 3 days per week.
Trial design
Treatments tested in this trial
- Propranolol
- Hydrocortisone
- Placebo (oral)
- Placebo (IM)
Treatment groups
88 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov