The Effects of Propranolol and Hydrocortisone on Military-Relevant Performance Outcomes

Part of paid clinical trials in Silver Spring, Maryland.

Sponsor
Walter Reed Army Institute of Research (WRAIR)
Study ID
NCT06982183
Phase
PHASE4
Status
Recruiting
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Conditions

  • Acute Stress Reaction
  • Fear of Spiders

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Propranolol — DRUG
    An administration of a 40-mg propranolol capsule immediately after tarantula exposure
  • Hydrocortisone — DRUG
    An intramuscular administration of 62.5 mg/1 ml of hydrocortisone immediately after tarantula exposure
  • Placebo (oral) — DRUG
    An administration of a placebo capsule after tarantula exposure
  • Placebo (IM) — DRUG
    An intramuscular administration of 1 ml of saline immediately after tarantula exposure

Study Details

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.

Key Dates

Start date
May 27, 2025
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Propranolol (oral)
  • Placebo Comparator: Placebo (oral)
  • Active Comparator: Hydrocortisone (IM)
  • Placebo Comparator: Placebo (IM)

Primary Outcome Measure

Psychomotor Vigilance Task [ Time Frame: Baseline and post-treatment time points within approximately 7 hours following the study medication administration. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sleep Research Center (SRC), Walter Reed Army Institute of ResearchSilver SpringMaryland20910
Lonique Moore, MSPH
[email protected]
301-319-9287
Beza Negash, BS, BA
[email protected]
301-319-9287

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By research site
Sleep Research Center (SRC), Walter Reed Army Institute of Research· Silver Spring, MD

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