Trial Outcomes & Findings for Effects of Intramuscular (IM) Oxytocin on Pupil Diameter and Heart Rate Variability (HRV) (NCT NCT04105998)
NCT ID: NCT04105998
Last Updated: 2022-11-10
Results Overview
Magnitude of power at the dominant frequency in the Fourier transform of pupil diameter in the .1-2 Hz range, termed hippus. Pupil measurements will be made for 20 seconds every 5 minutes for 20 minutes. The Fast Fourier Transform (FFT) essentially takes what looks like a random, noisy signal and distills it into a combination of many sine waves, each with different frequencies and different sizes (think ocean waves, which has the big wave we see and the small up and down wavelets on the top of the water). The primary outcome measure is the size of the largest wave in the frequency range above in this FFT analysis. Its dimensions are milliseconds\^2.
COMPLETED
PHASE4
22 participants
From 20 minutes before until study drug injection
2022-11-10
Participant Flow
Recruitment was performed via advertising in the community and internally within the medical center. Subjects who met inclusion criteria were scheduled for a visit at the Pain Research Clinical Research Unit where the written informed consent was obtained. The enrollment period was 10/24/2019 to 11/01/2021
Participant milestones
| Measure |
Oxytocin First
Participant received intravenous oxytocin, 10 IU on study day 1 and placebo on study day 2
|
Placebo First
Participant received intravenous placebo on study day 1 and oxytocin, 10 IU on study day 2
|
|---|---|---|
|
First Study Day
STARTED
|
12
|
10
|
|
First Study Day
COMPLETED
|
12
|
10
|
|
First Study Day
NOT COMPLETED
|
0
|
0
|
|
Second Study Day
STARTED
|
12
|
10
|
|
Second Study Day
COMPLETED
|
10
|
10
|
|
Second Study Day
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Oxytocin First
Participant received intravenous oxytocin, 10 IU on study day 1 and placebo on study day 2
|
Placebo First
Participant received intravenous placebo on study day 1 and oxytocin, 10 IU on study day 2
|
|---|---|---|
|
Second Study Day
Altered frequency and times of measurements on both study days
|
2
|
0
|
Baseline Characteristics
Effects of Intramuscular (IM) Oxytocin on Pupil Diameter and Heart Rate Variability (HRV)
Baseline characteristics by cohort
| Measure |
Oxytocin on Study Day 1 and Placebo Study Day 2
n=12 Participants
Participant received intravenous oxytocin, 10 International Units (IU) on study day 1 and intravenous placebo on study day 2
|
Placebo on Study Day 1 and Placebo
n=10 Participants
Participant received intravenous placebo on study day 1 and intravenous oxytocin, 10 International Units (IU) on study day 2
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 12 • n=99 Participants
|
35 years
STANDARD_DEVIATION 15 • n=107 Participants
|
35 years
STANDARD_DEVIATION 13 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
10 participants
n=107 Participants
|
22 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From 20 minutes before until study drug injectionMagnitude of power at the dominant frequency in the Fourier transform of pupil diameter in the .1-2 Hz range, termed hippus. Pupil measurements will be made for 20 seconds every 5 minutes for 20 minutes. The Fast Fourier Transform (FFT) essentially takes what looks like a random, noisy signal and distills it into a combination of many sine waves, each with different frequencies and different sizes (think ocean waves, which has the big wave we see and the small up and down wavelets on the top of the water). The primary outcome measure is the size of the largest wave in the frequency range above in this FFT analysis. Its dimensions are milliseconds\^2.
Outcome measures
| Measure |
Oxytocin
n=20 Participants
Participant received intravenous oxytocin, 10 International Units (IU) on study day 1 or 2
|
Placebo
n=20 Participants
Participant received intravenous placebo on study day 1 or 2
|
|---|---|---|
|
Fluctuation in Pupil Diameter (Hippus) -Pre Drug Administration
|
1.61 milliseconds^2
Standard Deviation 1.20
|
1.71 milliseconds^2
Standard Deviation 1.26
|
PRIMARY outcome
Timeframe: For 90 minutes after study drug administrationMagnitude of power at the dominant frequency in the Fourier transform of pupil diameter in the .1-2 Hz range, termed hippus. Pupil measurements will be made for 20 seconds every 5 minutes until 90 minutes after study drug administration. The Fast Fourier Transform (FFT) essentially takes what looks like a random, noisy signal and distills it into a combination of many sine waves, each with different frequencies and different sizes (think ocean waves, which has the big wave we see and the small up and down wavelets on the top of the water). The primary outcome measure is the size of the largest wave in the frequency range above in this FFT analysis. Its dimensions are milliseconds\^2.
Outcome measures
| Measure |
Oxytocin
n=20 Participants
Participant received intravenous oxytocin, 10 International Units (IU) on study day 1 or 2
|
Placebo
n=20 Participants
Participant received intravenous placebo on study day 1 or 2
|
|---|---|---|
|
Fluctuation in Pupil Diameter (Hippus) -Post Drug Administration
|
1.34 milliseconds^2
Standard Deviation 0.56
|
1.52 milliseconds^2
Standard Deviation 0.68
|
PRIMARY outcome
Timeframe: For 120 minutes after study drug administrationMagnitude of power at the dominant frequency in the Fourier transform of pupil diameter in the .1-2 Hz range, termed hippus. Pupil measurements will be made for 20 seconds every 5 minutes until 120 minutes after study drug administration. The Fast Fourier Transform (FFT) essentially takes what looks like a random, noisy signal and distills it into a combination of many sine waves, each with different frequencies and different sizes (think ocean waves, which has the big wave we see and the small up and down wavelets on the top of the water). The primary outcome measure is the size of the largest wave in the frequency range above in this FFT analysis. Its dimensions are milliseconds\^2.
Outcome measures
| Measure |
Oxytocin
n=7 Participants
Participant received intravenous oxytocin, 10 International Units (IU) on study day 1 or 2
|
Placebo
n=7 Participants
Participant received intravenous placebo on study day 1 or 2
|
|---|---|---|
|
Fluctuation in Pupil Diameter (Hippus) -Post Drug Administration
|
0.98 milliseconds^2
Standard Deviation 0.54
|
1.49 milliseconds^2
Standard Deviation 1.39
|
PRIMARY outcome
Timeframe: From 20 minutes before until study drug injectionMagnitude of peak power in the 0.12-0.40 Hz frequency range of the Fast Fourier Transform of heart rate. The Fast Fourier Transform (FFT) essentially takes what looks like a random, noisy signal and distills it into a combination of many sine waves, each with different frequencies and different sizes (think ocean waves, which has the big wave we see and the small up and down wavelets on the top of the water). The primary outcome measure is the size of the largest wave in the frequency range above in this FFT analysis. Its dimensions are milliseconds\^2.
Outcome measures
| Measure |
Oxytocin
n=20 Participants
Participant received intravenous oxytocin, 10 International Units (IU) on study day 1 or 2
|
Placebo
n=20 Participants
Participant received intravenous placebo on study day 1 or 2
|
|---|---|---|
|
Heart Rate Variability in the High Frequency Range
|
182 milliseconds^2
Standard Deviation 151
|
253 milliseconds^2
Standard Deviation 296
|
PRIMARY outcome
Timeframe: For 90 minutes after study drug administrationMagnitude of peak power in the 0.12-0.40 Hz frequency range of the Fast Fourier Transform of heart rate. The Fast Fourier Transform (FFT) essentially takes what looks like a random, noisy signal and distills it into a combination of many sine waves, each with different frequencies and different sizes (think ocean waves, which has the big wave we see and the small up and down wavelets on the top of the water). The primary outcome measure is the size of the largest wave in the frequency range above in this FFT analysis. Its dimensions are milliseconds\^2.
Outcome measures
| Measure |
Oxytocin
n=20 Participants
Participant received intravenous oxytocin, 10 International Units (IU) on study day 1 or 2
|
Placebo
n=20 Participants
Participant received intravenous placebo on study day 1 or 2
|
|---|---|---|
|
Heart Rate Variability in the High Frequency Range
|
183 milliseconds^2
Standard Deviation 158
|
300 milliseconds^2
Standard Deviation 296
|
PRIMARY outcome
Timeframe: For 120 minutes after study drug administrationMagnitude of peak power in the 0.12-0.40 Hz frequency range of the Fast Fourier Transform of heart rate. The Fast Fourier Transform (FFT) essentially takes what looks like a random, noisy signal and distills it into a combination of many sine waves, each with different frequencies and different sizes (think ocean waves, which has the big wave we see and the small up and down wavelets on the top of the water). The primary outcome measure is the size of the largest wave in the frequency range above in this FFT analysis. Its dimensions are milliseconds\^2.
Outcome measures
| Measure |
Oxytocin
n=7 Participants
Participant received intravenous oxytocin, 10 International Units (IU) on study day 1 or 2
|
Placebo
n=7 Participants
Participant received intravenous placebo on study day 1 or 2
|
|---|---|---|
|
Heart Rate Variability in the High Frequency Range
|
247 milliseconds^2
Standard Deviation 216
|
381 milliseconds^2
Standard Deviation 273
|
Adverse Events
Oxytocin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. James Eisenach
Wake Forest University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place