Oxytocin for PTSD
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether oxytocin, a hormone, can enhance Prolonged Exposure (PE) therapy for Veterans with PTSD. The researchers aim to determine if oxytocin can reduce PTSD symptoms, accelerate symptom relief, and improve therapy adherence. The study compares oxytocin with a placebo (a non-active treatment) and can be conducted from home using video calls. Veterans diagnosed with PTSD in the last six months and stable on any required medications might be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering Veterans a chance to contribute to important findings.
Do I have to stop taking my current medications for the trial?
You don't have to stop taking your current medications, but you must be on a stable dose of any psychotropic medications for at least four weeks before starting the trial.
Will I have to stop taking my current medications?
Participants must be on a stable dose of their current psychotropic medications for at least four weeks before starting the study. If you have recently started any new medications, you may need to wait until they are stable for four weeks before participating.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using oxytocin as a nasal spray is generally safe and well-tolerated. Studies have found it has a strong safety record, with people typically not experiencing serious side effects. Oxytocin is also affordable and accessible, making it a promising treatment option. Although not all studies demonstrate its effectiveness in reducing PTSD symptoms, its safety makes it worth considering for those exploring new treatments.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for PTSD, which often include antidepressants like SSRIs or trauma-focused therapies, oxytocin offers a unique approach by harnessing a naturally occurring hormone known for its role in social bonding and stress reduction. Researchers are excited about oxytocin because it is administered intranasally, allowing for rapid absorption and potentially quicker effects. This method could enhance emotional regulation and social functioning, offering a novel pathway to alleviate PTSD symptoms that current treatments might not address as effectively.
What evidence suggests that oxytocin might be an effective treatment for PTSD?
This trial will compare the effects of oxytocin and a placebo in treating PTSD. Research suggests that oxytocin might enhance the effectiveness of PTSD treatments, especially when combined with proven therapy methods. Oxytocin seems to aid by influencing brain areas that manage emotions and stress. Some studies have shown that oxytocin can lessen PTSD symptoms, although evidence from single doses remains limited. In animal studies, oxytocin reduced reactions to trauma. Overall, oxytocin shows promise as a way to support existing PTSD therapies and improve outcomes for those affected.12345
Who Is on the Research Team?
Julianne Christina Flanagan, PhD
Principal Investigator
Ralph H. Johnson VA Medical Center, Charleston, SC
Are You a Good Fit for This Trial?
This trial is for Veterans with PTSD, who can consent and perform well on a mental status exam. They may have mood or anxiety disorders but not bipolar disorder or current severe suicidal thoughts. Stable psychotropic medication use is okay.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Prolonged Exposure (PE) therapy combined with either oxytocin or placebo for PTSD
Follow-up
Participants are monitored for PTSD symptom severity and treatment adherence
What Are the Treatments Tested in This Trial?
Interventions
- Oxytocin
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
San Francisco VA Health Care System
Collaborator