Phase 4
N=10
Effects of Intramuscular Oxytocin on Sensory Function in Healthy Volunteers With Ultraviolet Burn Injury to the Skin
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT03935399 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Change in Vibration Frequency Detection Threshold (When Vibration is First Felt) After IM Injection — 22; 21 Hz — p=0.83
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oxytocin (Drug); Saline (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Vibration Frequency Detection Threshold (When Vibration is First Felt) After IM Injection |
22; 21 | 0.83 |
| PRIMARY Change in Pain Threshold (the Point Where Pain is First Perceived) to a Punctate Mechanical Stimulus After IM Injection. |
0.20; 0.29 | 0.92 |
| PRIMARY Change in Hypersensitivity to Von Frey Filament (225 milliNewton) After IM Injection. |
6.4; 8.8 | 0.79 |
| PRIMARY Change in Vibration Frequency Detection of Fixed Frequency (When Vibration is First Felt) After IM Injection |
1.8; 1.7 | 0.93 |
| SECONDARY Change in Sustained Heat After IM Injection Non Dominant Arm |
-0.30; -0.70 | 0.89 |
| SECONDARY Change in Sustained Heat After IM Injection |
0.10; -0.20 | 0.83 |
| SECONDARY Change in Sustained Heat After IM Oxytocin or Placebo Injection (Lower Leg) |
-0.55; 0.10 | 0.57 |
Summary
This study proposes to evaluate the effects that a dose of oxytocin given by intramuscular (IM) injection (into the muscle) will have on an area of skin that has been exposed to ultraviolet (UV) light. The area of skin exposed to UV light will have a mild sun burn feeling.
Sensory testing will be performed on the area of UV burn. The area will be evaluated for sensitivity in 3 methods: touch, vibratory
Eligibility Criteria
Inclusion Criteria
- Male or female > 18 and < 60 years of age,
- Body Mass Index (BMI) <40
- Generally in good health as determined by the Principal Investigator based on prior medical history
- Normal blood pressure and resting heart rate without medication
Exclusion Criteria
- 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 risk
- Women who are pregnant (positive result for serum pregnancy test at screening visit), women who are currently nursing or lactating, women that have been pregnant within 2 years.
- Neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
Data sourced from ClinicalTrials.gov (NCT03935399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.