Propranolol + Hydrocortisone + Morphine for Fear Response
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how three existing medications—propranolol (a beta-blocker), hydrocortisone (a corticosteroid), and morphine (an opioid pain reliever)—affect stress reactions, particularly in individuals with a fear of spiders. The goal is to understand how these drugs might help manage Acute Stress Reactions. Participants will encounter a tarantula and then undergo various cognitive and motor tests to assess the medications' impact on their performance. The trial seeks adults who are physically healthy, have a significant fear of spiders, and live close enough to commute to Walter Reed Army Institute of Research. As a Phase 4 trial, this research focuses on understanding how these FDA-approved and effective treatments can benefit more patients.
Will I have to stop taking my current medications?
Yes, you may need to stop taking certain medications. The trial excludes participants who are currently using medications that could interact with propranolol, hydrocortisone, or morphine, such as opioids, steroids, anti-hypertensives, and certain antidepressants. It's best to discuss your current medications with the study medical investigator to see if they need to be stopped.
What is the safety track record for these treatments?
Past studies have found propranolol safe for many people, but warnings exist about risks, especially when used for anxiety. Some reports suggest potential harm, so caution is advised.
Research on hydrocortisone shows it might increase anxiety in some cases, but it is generally well-tolerated. It aids in managing fear responses and has been used safely in many situations.
Morphine is commonly used for pain relief and has a long history of safe use when taken correctly. However, some studies suggest it might negatively affect stress responses. Medical supervision is important when using it.
All three medications in this trial—propranolol, hydrocortisone, and morphine—are FDA-approved for other uses, providing extensive safety information. However, individual reactions can vary, so discussing any concerns with the trial team is essential.12345Why are researchers enthusiastic about this study treatment?
Unlike the standard treatments for fear response, which often include cognitive-behavioral therapy and SSRIs, the combination of propranolol, hydrocortisone, and morphine offers a novel approach. Propranolol is unique because it may help dampen the emotional impact of memories by blocking adrenaline, potentially reducing fear more effectively. Hydrocortisone, typically known for its anti-inflammatory properties, might play a role in modifying stress response pathways. Morphine, usually recognized for pain relief, could add a calming effect that further mitigates fear. Researchers are excited because this multi-pronged approach could offer faster and more comprehensive relief from fear responses than existing treatments.
What evidence suggests that this trial's treatments could be effective for fear response?
This trial will compare the effects of Propranolol, Hydrocortisone, and Morphine on fear response. Research has shown that Propranolol, which participants in this trial may receive, can reduce fear and anxiety, particularly in cases like fear of spiders. It affects the brain's fear response, as demonstrated in studies where it lowered fear reactions. Hydrocortisone, another treatment option in this trial, has shown mixed results; it might not directly reduce fear, but it has been used to help people process emotional information better. Some studies suggest it aids in dealing with fear-inducing situations. Morphine, also under study in this trial, has evidence supporting its role in lowering the risk of PTSD (post-traumatic stress disorder) after traumatic events. It can help manage stress responses, possibly by altering how the brain reacts to trauma.12678
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of cognitive performance, mood, and physiological responses.
What Are the Treatments Tested in This Trial?
Interventions
- Hydrocortisone
- Morphine
- Propranolol
Find a Clinic Near You
Who Is Running the Clinical Trial?
Walter Reed Army Institute of Research (WRAIR)
Lead Sponsor