75 Participants NeededMy employer runs this trial

Oxytocin for Pain After Pituitary Surgery

SB
HR
Overseen ByHelena Rutherford, PhD
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 examines whether oxytocin, a hormone often linked to social bonding, can reduce pain after pituitary surgery by altering how the brain processes emotions and social connections. Participants will receive either a low dose or high dose of oxytocin, or a placebo, starting one week before surgery and continuing until one week after. The trial is suitable for post-menopausal women with a pituitary lesion requiring surgery, who speak English, and have not had previous pituitary surgery. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Do I need to stop taking my current medications to join the trial?

If you have been on a stable dose of psychotropic medication for at least six weeks, you can continue taking it. However, if your medication has changed recently, you may not be eligible. The trial does not specify other medication restrictions.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that oxytocin is generally safe for humans. In one study, participants who inhaled oxytocin did not report any negative effects. The treatment did not affect heart or blood vessel function, indicating no serious side effects related to the heart or blood flow.

For higher doses, the information remains less clear. However, since the study is in an early phase, earlier tests have demonstrated that the treatment is safe enough to proceed with more participants. This is promising, as treatments with serious safety issues typically do not advance to this stage.

Overall, oxytocin appears safe for people, at least in the doses studied so far. Further studies will provide more information about its safety at higher doses.12345

Why do researchers think this study treatment might be promising?

Oxytocin is unique because it's being explored as a potential treatment for pain management after pituitary surgery, which is different from the usual pain medications like opioids or non-steroidal anti-inflammatory drugs (NSAIDs). Researchers are excited about oxytocin because it could offer a pain relief option that works through a different mechanism, as oxytocin is a hormone that's naturally involved in social bonding and reducing stress, which might also help with pain perception. Unlike standard treatments, oxytocin may provide a novel approach to managing post-surgical pain with potentially fewer side effects and a lower risk of dependency, making it an attractive alternative for patients undergoing pituitary surgery.

What evidence suggests that oxytocin might be an effective treatment for pain after pituitary surgery?

This trial will compare the effects of different doses of oxytocin on pain after pituitary surgery. Research has shown that oxytocin might help reduce pain after surgery. One study found that patients who inhaled oxytocin needed fewer painkillers and felt less pain. Another study showed that people using oxytocin experienced 43% less pain compared to those who did not use it. These findings suggest that oxytocin could help manage pain by affecting how the brain handles emotions and social interactions. While more research is needed, current evidence is promising for its use in reducing pain after surgery. Participants in this trial will receive either a low dose or high dose of oxytocin, or a placebo, to evaluate its effectiveness in managing post-surgical pain.678910

Who Is on the Research Team?

SB

S. Bulent Omay, MD

Principal Investigator

Yale University

HR

Helena Rutherford, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for people who have had pituitary surgery and are experiencing pain. Participants should be able to use a nasal spray and follow study instructions. Those with certain medical conditions or allergies may not be eligible.

Inclusion Criteria

Ability to give informed consent
Proficiency in the English language
I have not had a menstrual period for at least one year.
See 2 more

Exclusion Criteria

I have changed my psychiatric medication in the last six weeks.
Currently pregnant, currently lactating, or up to 1-year post partum
I have a history of seizures.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intranasal oxytocin or placebo daily for 7 days before surgery, on the day of surgery, and for 7 days after surgery

2 weeks
Daily self-administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain, depression, and anxiety assessments

8 weeks
Regular assessments

What Are the Treatments Tested in This Trial?

Interventions

  • Oxytocin

Trial Overview

The study is testing two different doses of oxytocin nasal spray versus a placebo (saline) to see if oxytocin can help reduce pain after pituitary surgery by affecting emotions and social processing in the brain.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Low Dose OxytocinExperimental Treatment1 Intervention
Group II: High Dose OxytocinExperimental Treatment1 Intervention
Group III: Saline-Mg solutionPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials
1,963
Recruited
3,046,000+

Tonix Pharmaceuticals, Inc.

Industry Sponsor

Trials
31
Recruited
4,900+

Citations

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