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NCT05179421 · ClinicalTrials.gov registry record · Phase 2
Dose Ranging Study of Intravenous Oxytocin for Analgesia to Heat Pain
A Phase 2 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT05179421 is a Phase 2 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 25 participants.
The verdict
NCT05179421, a Phase 2 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
This is a study of participants that will receive intravenous (IV) infusions of oxytocin (naturally occurring hormone that is made by the brain). In this study healthy participants will be recruited for the study. There will be 3 study related visits: 1) screening and informed consent 2) study medication infusions and thermal heat testing 3) study medication infusions and thermal heat testing. During study visits 2 and 3 an IV catheter will be placed and a dose of oxytocin or placebo (inactive solution) will be given over a 10 minute period; 1 hour after the first infusion, a second 10 minute infusion of oxytocin will be administered. Investigators will perform some tests to evaluate how oxytocin changes perceptions of the skin. Investigators will study a painful perception by placing a probe on the skin of the side of lower leg and heating it up to 113-117 degrees Fahrenheit (F) (45-47 degrees Celsius (C)) for 5 minutes. Each participant will score any pain that is experienced on a 0 to 10 scale for each minute during the heating period. Most people find that pain rises during the 5 minutes, but remains mild; usually less than 5 on the 0 to 10 pain scale. The temperature of the 5 minute heating will be determined according to the participants pain rating during the screening visit. The primary objective of the study is to determine the dose response of IV oxytocin for analgesia (pain relief) to experimental heat pain.
Interventions
- DRUG Low dose oxytocin
- DRUG High dose oxytocin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2022-05-09 |
| Est. Completion | 2023-02-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05179421
The ClinicalTrials.gov registry entry for NCT05179421 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Low dose oxytocin is the first listed.
NCT05179421 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05179421 about?
NCT05179421 is a clinical study titled "Dose Ranging Study of Intravenous Oxytocin for Analgesia to Heat Pain". This is a study of participants that will receive intravenous (IV) infusions of oxytocin (naturally occurring hormone that is made by the brain). In this study healthy participants will be recruited for the study. There will be 3 study related visits: 1) screening and informed consent 2) study medi...
What is the current status of trial NCT05179421?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2022-05-09. Estimated completion is 2023-02-10.
What interventions are being tested in trial NCT05179421?
The interventions under investigation include: Low dose oxytocin (DRUG), High dose oxytocin (DRUG).
Who is sponsoring clinical trial NCT05179421?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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