Propranolol + Hydrocortisone + Morphine for Fear Response

Overseen By John Hughes, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Walter Reed Army Institute of Research (WRAIR)

Must not be taking: Antipsychotics, Anticonvulsants, Mood stabilizers, others

Disqualifiers: Neurologic disorder, Cardiovascular disease, Asthma, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

110 Participants Needed

Trial Summary

What is the purpose of this trial?

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 Criteria

This trial is for healthy adults aged 18-40 with a fear of spiders. It's designed to see how certain FDA-approved medications affect their cognitive, emotional, and motor skills after being stressed by exposure to a tarantula.

Inclusion Criteria

Score equal to or greater than 54 on the Fear of Spiders Questionnaire

My weight is between 91 and 250 pounds.

Live close enough to be able to commute to Walter Reed Army Institute of Research during the study participation.

Exclusion Criteria

Score of 41 or above on the State-Trait Anxiety Inventory - Trait (STAI-T)

I use certain drugs or products that may not be stopped safely for a study.

Failure to obtain required approved official leave to participate (federal civilian employees and active duty military only)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive one of five study medications (oral propranolol, oral placebo, IM hydrocortisone, IM morphine, or IM placebo) after a brief exposure to a tarantula. Cognitive and motor tasks and psychological assessments are conducted before and after medication administration.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of cognitive performance, mood, and physiological responses.

24-27 hours

Treatment Details

Interventions

• Hydrocortisone
• Morphine
• Propranolol

Trial Overview The study tests the effects of propranolol, hydrocortisone, morphine, and placebos (both oral and intramuscular) on performance in tasks that are important for military personnel. Participants will be given one of these treatments after encountering a spider.

Participant Groups

Group I: Propranolol (oral) Active Control 1 Intervention

Group II: Hydrocortisone (IM) Active Control 1 Intervention

Group III: Morphine (IM) Active Control 1 Intervention

Group IV: Placebo (oral) Placebo Group 1 Intervention

Group V: Placebo (IM) Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Walter Reed Army Institute of Research (WRAIR)

Lead Sponsor

Trials

111

Recruited

108,000+