Phase 4
N=11
PK Sampling After IV Oxytocin and Effects on Sensory Function in Healthy Volunteers
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT03929367 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Oxytocin Concentration — 1047 pg/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oxytocin (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oxytocin Concentration |
1.0 | — |
| PRIMARY Oxytocin Concentration |
1.0 | — |
| PRIMARY Oxytocin Concentration |
1.0 | — |
| PRIMARY Oxytocin Concentration |
1.0 | — |
| PRIMARY Oxytocin Concentration |
1.0 | — |
| PRIMARY Oxytocin Concentration |
1.0 | — |
| PRIMARY Oxytocin Concentration |
1.0 | — |
| PRIMARY Oxytocin Concentration |
1.0 | — |
| PRIMARY Oxytocin Concentration |
1.0 | — |
| PRIMARY Oxytocin Concentration |
1.0 | — |
| PRIMARY Oxytocin Concentration |
1.0 | — |
| SECONDARY Light Touch Frequency Threshold |
771 | — |
| SECONDARY Light Touch Frequency Threshold |
771 | — |
| SECONDARY Light Touch Frequency Threshold |
771 | — |
| SECONDARY Light Touch Frequency Threshold |
771 | — |
| SECONDARY Light Touch Frequency Threshold |
771 | — |
| SECONDARY Light Touch Frequency Threshold |
771 | — |
| SECONDARY Sustained Heat |
.86 | — |
| SECONDARY Sustained Heat |
.86 | — |
| SECONDARY Sustained Heat |
.86 | — |
| SECONDARY Sustained Heat |
.86 | — |
| SECONDARY Sustained Heat |
.86 | — |
| SECONDARY Sustained Heat |
.86 | — |
| SECONDARY Sustained Heat |
.86 | — |
| SECONDARY Sustained Heat |
.86 | — |
| SECONDARY Sustained Heat |
.86 | — |
| SECONDARY Sustained Heat |
.86 | — |
| SECONDARY Sustained Heat |
.86 | — |
| SECONDARY Sustained Heat |
.86 | — |
| SECONDARY Sustained Heat |
.86 | — |
| SECONDARY Sustained Heat |
.86 | — |
| SECONDARY Sustained Heat |
.86 | — |
| SECONDARY Sustained Heat |
.86 | — |
| SECONDARY Sustained Heat |
.86 | — |
| SECONDARY Sustained Heat |
.86 | — |
| SECONDARY Sustained Heat |
.86 | — |
| SECONDARY Sustained Heat |
.86 | — |
Summary
The primary goal of this protocol is to model change in oxytocin concentrations in plasma after intravenous (IV) administration. Additional measurements will be performed on sensory function that could be influenced by oxytocin during later time periods when blood samples are widely separated by time. This protocol will describe the pharmacokinetics (PK) of intravenous oxytocin in healthy adult men and adult,non-pregnant women. PK samples will be obtained after an injection of intravenous oxytocin 10 IU over 60 seconds.
Blood will be drawn for the PK samples prior to the oxytocin administration and then 11 times after administration.
There are two additional measures which will assess two different aspects of sensory function.
MEASURE 1: Light Touch Frequency Threshold In order to determine the highest frequency that specific nerve fibers can respond to, a simple device that produces an oscillatory / vibratory stimulus will be used on the hand. The subject places fingertips, palm, and palm side of the wrist sequentially and the device is set to slowly decrease the frequency of vibration from 1 kHz until the subject first perceives this. This is repeated three times at each site and takes less than 5 minutes in total. This will be performed before the oxytocin administration and 6 times after the administration of IV Oxytocin.
MEASURE 2: Sustained Heat The surface of the skin of the forearm or leg is heated to 113°F using a computer controlled thermode for a period of 5 minutes. This will be done before the IV Oxytocin and 4 times after the administration. A set of random thermal temperatures (98°F-122°F) will also be applied to the skin of the leg or forearm before the IV Oxytocin administration and 4 times after administration of IV Oxytocin.
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, American Society of Anesthesiologists physical status I or II
- Normal blood pressure (systolic 90-140 mmHg; diastolic 50-90 mmHg) resting heart rate 45-100 beats per minute) without medication
- Female subjects of child-bearing potential and those < 1 year post-menopausal, must be practicing highly effective methods of birth control such as hormonal methods
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 (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data
- 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
- Subjects with neuropathy, chronic pain, diabetes mellitus, or taking benzodiazepines or pain medications on a daily basis.
Data sourced from ClinicalTrials.gov (NCT03929367). 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.