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

ConditionsFear of Spiders Acute Stress Reaction

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

88 Participants

are divided into 4 treatment groups

Group A: Propranolol (oral)Active comparator 1 intervention

Group B: Placebo (oral)Placebo comparator 1 intervention

Group C: Hydrocortisone (IM)Active comparator 1 intervention

Group D: Placebo (IM)Placebo comparator 1 intervention

Trial outcomes