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New treatment option for Chronic Pain
Official title Generate and Test the Reliability of a PD Model of OXT on Pupillary Hippus as a Measure of CNS Activity
ClinicalTrials.gov ID: NCT04427709
What this study is testing
What is Oxytocin?
Oxytocin is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for chronic pain.
Also referred to as Pitocin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this research is to evaluate the effects of oxytocin (naturally occurring hormone) given by an intramuscular (IM; into the muscle) injection, has on your parasympathetic nervous system. The parasympathetic nervous system is the part of the involuntary nervous system that is sometimes called the "rest and digest" system; the parasympathetic system conserves energy as it slightly slows the heart rate, increases intestinal and gland activity, and relaxes sphincter muscles in the gastrointestinal tract.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Male or female \> 18 and \< 75 years of age, Body Mass Index (BMI) \<40.
- Generally in good health as determined by the Principal Investigator based on prior medical history, American Society of Anesthesiologists physical...
- For healthy volunteers, normal blood pressure (systolic 90-140 mmHg; diastolic 50-90 mmHg) resting heart rate 45-100 beats per minute) without...
- Female people of child-bearing potential and those \< 1 year post-menopausal, must be practicing highly effective methods of birth control such as...
You likely can't join if
- Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®
- Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased...
- Women who are pregnant (positive result for serum pregnancy test at screening visit), women who are currently nursing or lactating, women that have...
- people with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
- people with eye pathology, eye surgery, or taking topical eye medications, or any disease process that would cause motor tremors or excessive eye...
The study team makes the final eligibility decision.
Where it's taking place
- Winston-Salem, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Winston-Salem, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.