Fear of SpidersPhase 4NCT06982183
The Effects of Propranolol and Hydrocortisone on Military-Relevant Performance Outcomes
A Phase 4 study testing Propranolol and Hydrocortisone in people with Fear of Spiders and Acute Stress Reaction, run by Walter Reed Army Institute of Research (WRAIR) at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Fear of Spiders, Acute Stress Reaction
- What is being tested?
- Propranolol and Hydrocortisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2025to Sep 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Self-reported caffeine use in excess of 600 mg (e.g., approximately 10 caffeinated sodas or approximately 29 ounces of brewed coffee) per day on average or not being able to go without caffeine during the In-Lab visits.
- History of neurologic disorder (to include but not limited to epilepsy, hydrocephalus, MS). An infrequent or resolved single neurological event (e.g., childhood seizure, rare sporadic migraine headaches, resolved meningeal infection with no sequelae) or a history of mild traumatic brain injury may be deemed non-exclusionary at the discretion of the examining study medical investigator
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- Score of 10 or above on the Beck Depression Inventory (BDI) or a score of > 0 on item 9 "Suicidal Thoughts or Wishes" of the BDI
- Score of 41 or above on the State-Trait Anxiety Inventory - Trait (STAI-T).
- Score of 20 or above on the PROMIS Emotional Distress - Anxiety - Short Form.
- Score of 33 or above on the PTSD Checklist, 5th Edition (PCL-5)
- History of cardiovascular disease (to include but not limited to arrhythmias, valvular heart disease, congestive heart failure, history of sudden cardiac death or myocardial infarction).
- A history of asthma or any type of reactive airways disease or any acute or chronic pulmonary disorder that could lead to a compromise of blood oxygenation in the setting of a modest reduction in tidal volume or respiratory rate, to include neuromuscular disorders.
- Regularly work night shifts or have a habitual sleep/wake schedule that is not conducive to compliance with the recommended sleep time (11:00 pm - 6:00 am) during participation (e.g., extremely early or late habitual bedtime or rise time, to be determined on a case-by-case basis by the principal investigator or an associate investigator).
- A diagnosis of sleep apnea.
- Kidney disease or kidney abnormalities, liver disease or liver abnormalities, or any other metabolic derangements (endocrine disorders, hyperglycemia, etc.) that could alter neurophysiological function.
- Liver disease or significant liver abnormalities as determined by examining study medical investigator.
- Self-reported history of hospitalization for a psychiatric disorder within the past year or with a previous history of a psychotic, bipolar disorder or personality disorder. For a history of a diagnosis of any other psychiatric disorder, a potential participant's symptoms must either be resolved to a degree that a diagnosis is no longer applied or their symptoms must have been stabilized by pharmacological or nonpharmacological treatments for a period of at least 90 days or greater as deemed exclusionary or non-exclusionary at the discretion of the examining study medical investigator.
- Self-reported or suspected current use of antipsychotics, anticonvulsants, or mood stabilizers, to be determined on a case-by-case basis by the examining study medical investigator.
- Self-reported or suspected current use of products or drugs that have CNS depressant effects, to be determined on a case-by-case basis by the examining study medical investigator.
- Self-reported or suspected use of products or drugs that cannot be safely discontinued during in-laboratory phases, to be determined on a case-by-case basis by the examining study medical investigator.
- Self-reported or suspected current heavy alcohol use (minimum limit to define heavy alcohol use is 14 drinks per week for males and 7 drinks per week for females or as determined by the examining study medical investigator).
- (Females only) Positive urine pregnancy result
- (Females only) Self-reported or suspected current breast-feeding or collecting breast-milk.
- Resting blood pressure above 140/90 or resting pulse > 110 beats per minute. Note that if a repeat measurement is within range, the volunteer will not be excluded.
- Resting blood pressure below 100/60 or pulse oxygenation <92%. Volunteers with a resting pulse < 60 bpm will be excluded unless a history of regular vigorous aerobic exercise and findings on the physical examination (including BMI) suggest a high level of cardiovascular fitness, in which case a resting pulse in the range of 50 - 59 bpm may not be exclusionary.
- BMI ≥ 31. The inclusion of individuals with BMI between 30 and 31 (Obese Class I) will be determined using medical investigator's discretion.
- Clinically significant values (as determined by the reviewing study medical investigator) for any hematology or chemistry parameter. Reviewing study medical investigator may opt to repeat any clinically significant tests and include volunteers whose repeat test values are not clinically significant.
- Currently on or recently ended immunotherapy (e.g., allergy shots).
- Have taken a vaccine within 30 days prior to enrollment to the study. For volunteers who report recently taking a vaccine during the screening visit, their In-Lab Day 1 visit will be scheduled at least 30 days after the date of the most recent vaccination.
- Positive urine drug result during screening visit or In-Lab Days 1- 2; Exhibiting behaviors consistent with illicit drug use on In-Lab Day 3.
- Positive saliva alcohol result during screening visit or In-Lab Days 1-3.
- Inability to read and sign consent.
- Failure to obtain required approved official leave to participate (federal civilian employees and active duty military only)
- Failure to cooperate with requirements of the study
- Failure to provide viable emergency contact(s) for the duration of the study
- Self-reported or suspected current use of illicit drugs (including but not limited to benzodiazepines, amphetamines, cocaine, marijuana).
- Current use and/or prescription for opioid, steroid or anti-hypertensive and/or any medication the Medical Investigator deems would interact adversely with study compounds.
- Current use of medications that can adversely interact with propranolol, hydrocortisone and/or morphine to include anti-depressants that are cytochrome P450 2D6 inhibitors.
- Current diabetes.
- GI disorders - motility disorders
- Failure to pass certain tests
- Failure to provide a social security number or tax identification number in order to be paid for screening and participation in the study.
- Current participation in another ongoing clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sleep Research Center (SRC), Walter Reed Army Institute of Research
Silver Spring, Maryland, 20910
Lonique Moore, MSPH, 301-319-9287, Lonique.t.moore.ctr@health.mil
Beza Negash, BS, BA, 301-319-9287, beza.w.negash.ctr@health.mil
About this study
Official title: The Effects of Propranolol and Hydrocortisone on Military-Relevant Performance Outcomes: A Randomized, Blinded, Placebo Controlled Study
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:
Read more
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.
- Conditions
- Fear of Spiders, Acute Stress Reaction
- Being tested
- Propranolol, Hydrocortisone, Placebo (oral), Placebo (IM)
- Keywords
- Fear of Spiders, propranolol, hydrocortisone, randomized controlled trial, neuropsychological tests, acute stress reaction
- Medical subject headings
- Arachnophobia, Stress Disorders, Traumatic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
An administration of a 40-mg propranolol capsule immediately after tarantula exposure
HydrocortisoneDrug
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 group | Role | What they receive |
|---|---|---|
| Propranolol (oral) | Active comparator | Not described Receives: Drug: Propranolol |
| Placebo (oral) | Placebo comparator | Not described Receives: Drug: Placebo (oral) |
| Hydrocortisone (IM) | Active comparator | Not described Receives: Drug: Hydrocortisone |
| Placebo (IM) | Placebo comparator | Not described Receives: Drug: Placebo (IM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychomotor Vigilance Task
Measure of cognitive performance. Reaction time (millisecond)
Measured: Baseline and post-treatment time points within approximately 7 hours following the study medication administration.
Secondary outcomes (13)
Go/No-Go task
Measure of cognitive performance.
Measured: Baseline and post-treatment time points within approximately 7 hours following the study medication administration.
Matching to Sample task
Measure of cognitive performance
Measured: Baseline and post-treatment time points within approximately 7 hours following the study medication administration.
Simple Reaction Time task
Measure of cognitive performance.
Measured: Baseline and post-treatment time points within approximately 7 hours following the study medication administration.
The Automated Neuropsychological Assessment Metrics (ANAM) Mood Scale
Measure of mood.
Measured: Baseline and post-treatment time points within approximately 7 hours following the study medication administration.
WRAIR Mood Battery
A short battery of measures of various aspects of mood.
Measured: Baseline and post-treatment time points within approximately 7 hours following the study medication administration.
Heart rate
Continuous measure of heart rate.
Measured: Before, during, and after behavioral approach task. Approximately 1 hour.
Biosway
Measure of motor performance
Measured: Baseline and post-treatment time points within approximately 7 hours following the study medication administration.
Triple Hop Test
Measure of motor performance.
Measured: Baseline and post-treatment time points within approximately 7 hours following the study medication administration.
Drug Effects Questionnaire
Measure of subjective response to a substance.
Measured: Multiple time points within approximately 7 hours following the study medication administration.
Subjective Fear Scale
Subjective measure of fear. A 0 - 100 numerical scale.
Measured: Baseline, during the behavioral approach test, and time points within approximately 7 hours after the study medication administration.
Subjective Anxiety Scale
Subjective measure of anxiety. A 0 - 100 numerical scale.
Measured: Baseline, during the behavioral approach test, and time points within approximately 7 hours after the study medication administration.
Subjective Stress Scale
Subjective measure of stress. A 0 - 100 numerical scale.
Measured: Baseline, during the behavioral approach test, and time points within approximately 7 hours after the study medication administration.
Symptom checklist
Checklist to capture adverse drug reactions.
Measured: Baseline, pre-medication administration, and time points within approximately 8 hours after the medication administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start27 May 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of SpidersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Institute of Research (WRAIR)
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982183
- Sponsor's protocol ID
- WRAIR #2950
- Other IDs
- MO210072
- Status last verified
- May 2026
- First submitted
- 1 May 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Propranolol and Hydrocortisone on Military-Relevant Performance Outcomes: A Randomized, Blinded, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT06982183
- Acronym / sponsor ID
- WRAIR #2950
- Conditions
- Fear of Spiders, Acute Stress Reaction
- Keywords
- Fear of Spiders, propranolol, hydrocortisone, randomized controlled trial, neuropsychological tests, acute stress reaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Walter Reed Army Institute of Research (WRAIR)US federal agency
- Study start
- 27 May 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Propranolol (oral) | Active comparator | Drug: Propranolol |
| Placebo (oral) | Placebo comparator | Drug: Placebo (oral) |
| Hydrocortisone (IM) | Active comparator | Drug: Hydrocortisone |
| Placebo (IM) | Placebo comparator | Drug: Placebo (IM) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (43 listed)
- 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.
- Self-reported caffeine use in excess of 600 mg (e.g., approximately 10 caffeinated sodas or approximately 29 ounces of brewed coffee) per day on average or not being able to go without caffeine during the In-Lab visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropranololAn administration of a 40-mg propranolol capsule immediately after tarantula exposure | Drug | Propranolol (oral) |
| HydrocortisoneAn intramuscular administration of 62.5 mg/1 ml of hydrocortisone immediately after tarantula exposure | Drug | Hydrocortisone (IM) |
| Placebo (oral)An administration of a placebo capsule after tarantula exposure | Drug | Placebo (oral) |
| Placebo (IM)An intramuscular administration of 1 ml of saline immediately after tarantula exposure | Drug | Placebo (IM) |
Primary outcome
Psychomotor Vigilance Task
Time frame: Baseline and post-treatment time points within approximately 7 hours following the study medication administration.
Measure of cognitive performance. Reaction time (millisecond)
13 secondary outcomes
Go/No-Go task
Time frame: Baseline and post-treatment time points within approximately 7 hours following the study medication administration.
Matching to Sample task
Time frame: Baseline and post-treatment time points within approximately 7 hours following the study medication administration.
Simple Reaction Time task
Time frame: Baseline and post-treatment time points within approximately 7 hours following the study medication administration.
The Automated Neuropsychological Assessment Metrics (ANAM) Mood Scale
Time frame: Baseline and post-treatment time points within approximately 7 hours following the study medication administration.
WRAIR Mood Battery
Time frame: Baseline and post-treatment time points within approximately 7 hours following the study medication administration.
Heart rate
Time frame: Before, during, and after behavioral approach task. Approximately 1 hour.
Biosway
Time frame: Baseline and post-treatment time points within approximately 7 hours following the study medication administration.
Triple Hop Test
Time frame: Baseline and post-treatment time points within approximately 7 hours following the study medication administration.
Drug Effects Questionnaire
Time frame: Multiple time points within approximately 7 hours following the study medication administration.
Subjective Fear Scale
Time frame: Baseline, during the behavioral approach test, and time points within approximately 7 hours after the study medication administration.
Subjective Anxiety Scale
Time frame: Baseline, during the behavioral approach test, and time points within approximately 7 hours after the study medication administration.
Subjective Stress Scale
Time frame: Baseline, during the behavioral approach test, and time points within approximately 7 hours after the study medication administration.
Symptom checklist
Time frame: Baseline, pre-medication administration, and time points within approximately 8 hours after the medication administration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propranolol and Hydrocortisone in people with Fear of Spiders and Acute Stress Reaction, run by Walter Reed Army Institute of Research (WRAIR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Hughes, MD (301-319-3214, john.d.hughes4.civ@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychomotor Vigilance Task (time frame: Baseline and post-treatment time points within approximately 7 hours following the study medication administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.