Oxytocin for PTSD

No longer recruiting at 1 trial location
JT
CD
HF
JC
Overseen ByJulianne Christina Flanagan, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: VA Office of Research and Development
Must be taking: Psychotropic medications
Prior Safety DataThis treatment has passed at least one previous human trial

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?

JC

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

I have been on a stable dose of my mental health medication for at least 4 weeks.
You may have a mood disorder, except for bipolar affective disorder.
The study is only open to military veterans.
See 5 more

Exclusion Criteria

I started taking medication for anxiety, depression, or mood stabilization in the last 4 weeks.
Pregnancy or breastfeeding for women
Participants who present a serious suicide risk or are likely to require hospitalization during the study
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Prolonged Exposure (PE) therapy combined with either oxytocin or placebo for PTSD

10 weeks
Sessions may be completed via home-based telemedicine

Follow-up

Participants are monitored for PTSD symptom severity and treatment adherence

6 months
Follow-up assessments at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Oxytocin
  • Placebo
Trial Overview The study tests if oxytocin can improve PTSD symptoms and treatment retention in Veterans undergoing Prolonged Exposure therapy, compared to a placebo. Participants can join sessions via telemedicine using VA approved apps.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: OxytocinExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

San Francisco VA Health Care System

Collaborator

Trials
11
Recruited
865,000+

Published Research Related to This Trial

Palonosetron is a highly effective 5-HT(3) receptor antagonist for preventing chemotherapy-induced nausea and vomiting, with 71.9% of the drug remaining unchanged in plasma for up to 96 hours after administration.
The drug is primarily eliminated through the kidneys, with 83% of the dose recovered in urine, and it was generally well tolerated by participants, with no significant cardiac effects observed during monitoring.
Pharmacokinetics, metabolism and excretion of intravenous [l4C]-palonosetron in healthy human volunteers.Stoltz, R., Parisi, S., Shah, A., et al.[2022]
The combination of netupitant and palonosetron is effective in preventing both acute and delayed nausea and vomiting caused by moderately and highly emetogenic chemotherapy, as supported by phase II and III clinical trials.
This treatment offers a convenient single-capsule dosage and has a favorable side effect profile, although its high cost and administration logistics may pose challenges.
The role of netupitant and palonosetron in chemotherapy-induced nausea and vomiting.Abramovitz, RB., Gaertner, KM.[2018]
Palonosetron, a new 5-HT3 receptor antagonist, has been shown to effectively prevent both acute and delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately to highly emetogenic chemotherapy, demonstrating a longer half-life and higher binding affinity than older agents.
In clinical trials, palonosetron was as effective in controlling CINV during subsequent chemotherapy cycles as it was during the initial treatment, with no significant differences in safety profiles compared to other 5-HT3 receptor antagonists like ondansetron and dolasetron.
Palonosetron: a second-generation 5-hydroxytryptamine receptor antagonist.Navari, RM.[2018]

Citations

Augmenting Treatment for Posttraumatic Stress Disorder ...Oxytocin holds promise for facilitating more effective PTSD treatment, particularly when used in combination with evidence-supported psychotherapy interventions ...
Study Details | NCT04228289 | Oxytocin to Treat PTSDTotal PCL-5 Scores range from 17-85. Higher scores indicate greater symptom severity. End of Treatment (10 weeks). Secondary Outcome Measures ...
Intranasal oxytocin as a potential therapeutic strategy in ...IN-OT modulates activity in cognitive, emotion and reward brain areas in PTSD. · Clinical evidences of efficacy for single IN-OT administrations are limited.
Emotional remodeling with oxytocin durably rescues ...Our results show that three weeks following emotional remodeling with oxytocin, 83% of the rats identified as vulnerable to trauma became ...
5.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/28087128/
Intranasal Oxytocin to Prevent Posttraumatic Stress ...These findings suggest that oxytocin administration is a promising preventive intervention for PTSD for individuals with high acute PTSD symptoms.
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