Trial Outcomes & Findings for Peripheral Oxytocin and Touch (NCT NCT05326776)
NCT ID: NCT05326776
Last Updated: 2024-12-31
Results Overview
Touch pleasant/unpleasantness ratings will be assessed in response to slow gentle brushing using a "Pleasantness/Unpleasantness" Visual Analog Scale with anchors of "Extremely unpleasant" (coded -100) to "Neutral" to "Extremely pleasant (coded 100)." Change in mean rating of slow brushing will be compared between the oxytocin and placebo sessions. Higher values indicate increased pleasantness (better outcome).
COMPLETED
PHASE2
20 participants
Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)
2024-12-31
Participant Flow
Healthy adults were recruited from the local community as well as from our previous studies. Potential participants completed a telephone screening during which the study procedures were described, and eligibility criteria were reviewed.
Screening was conducted prior to enrollment. No participants were excluded after enrollment.
Participant milestones
| Measure |
Order 1
Participants will receive 4mcg/2ml oxytocin during Session 1 and 2ml isotonic saline during Session 2, injected into the forearm.
Pitocin: At each session, 4mcg/2ml oxytocin or 2ml isotonic saline (0.9% sodium chloride; placebo control) will be injected into the middle of the dorsal forearm. Sessions will be separated by at least 48 hours to ensure drug clearance.
|
Order 2
Participants will receive 2ml isotonic saline during Session 1 and 4mcg/2ml oxytocin during Session 2, injected into the forearm.
Pitocin: At each session, 4mcg/2ml oxytocin or 2ml isotonic saline (0.9% sodium chloride; placebo control) will be injected into the middle of the dorsal forearm. Sessions will be separated by at least 48 hours to ensure drug clearance.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Order 1
n=10 Participants
Participants will receive 4mcg/2ml oxytocin during Session 1 and 2ml isotonic saline during Session 2, injected into the forearm.
Pitocin: At each session, 4mcg/2ml oxytocin or 2ml isotonic saline (0.9% sodium chloride; placebo control) will be injected into the middle of the dorsal forearm. Sessions will be separated by at least 48 hours to ensure drug clearance.
|
Order 2
n=10 Participants
Participants will receive 2ml isotonic saline during Session 1 and 4mcg/2ml oxytocin during Session 2, injected into the forearm.
Pitocin: At each session, 4mcg/2ml oxytocin or 2ml isotonic saline (0.9% sodium chloride; placebo control) will be injected into the middle of the dorsal forearm. Sessions will be separated by at least 48 hours to ensure drug clearance.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.6 years
STANDARD_DEVIATION 12.5 • n=10 Participants
|
26.2 years
STANDARD_DEVIATION 6.5 • n=10 Participants
|
27.4 years
STANDARD_DEVIATION 9.8 • n=20 Participants
|
|
Sex/Gender, Customized
gender · female
|
5 Participants
n=10 Participants
|
7 Participants
n=10 Participants
|
12 Participants
n=20 Participants
|
|
Sex/Gender, Customized
gender · non-binary
|
1 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=20 Participants
|
|
Sex/Gender, Customized
gender · male
|
4 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
7 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)Population: All participants who completed both sessions.
Touch pleasant/unpleasantness ratings will be assessed in response to slow gentle brushing using a "Pleasantness/Unpleasantness" Visual Analog Scale with anchors of "Extremely unpleasant" (coded -100) to "Neutral" to "Extremely pleasant (coded 100)." Change in mean rating of slow brushing will be compared between the oxytocin and placebo sessions. Higher values indicate increased pleasantness (better outcome).
Outcome measures
| Measure |
Oxytocin Session
n=18 Participants
Data from during the Oxytocin Session, regardless of order.
|
Placebo Session
n=18 Participants
Data from during the Placebo saline Session, regardless of order.
|
|---|---|---|
|
Change in Mean Pleasantness Rating of Gentle Brushing
|
-8.7 score on a scale
Standard Deviation 23.0
|
-14.1 score on a scale
Standard Deviation 27.8
|
PRIMARY outcome
Timeframe: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)Population: All participants who completed both sessions.
"Mechanical threshold" task. Change in first reported percept of sharpness from application of a standard set of weighted pinprick stimuli (minimum 8mN; maximum 512 mN) will be compared between the oxytocin and placebo sessions. An increased threshold indicates reduced sensitivity to mechanical pain.
Outcome measures
| Measure |
Oxytocin Session
n=18 Participants
Data from during the Oxytocin Session, regardless of order.
|
Placebo Session
n=18 Participants
Data from during the Placebo saline Session, regardless of order.
|
|---|---|---|
|
Change in Mechanical Threshold
|
65.3 mN
Standard Deviation 143.1
|
63.2 mN
Standard Deviation 125.9
|
PRIMARY outcome
Timeframe: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)Population: All participants who completed both sessions.
Temporal summation will be tested using a standard 256 milliNewtons (mN) pinprick stimulus applied for 10 repetitions. The participant will provide pain ratings for a single pinprick and for the 10 repetitions, using a Visual Analog Scale rating scale with anchors "No pain" to "Most intense pain imaginable." This procedure will be repeated 5 times and the mean pain rating for the repeated pinprick will be divided by the mean rating of the single pinprick to obtain the standard temporal summation ratio. Change in ratio will be compared between the oxytocin and placebo sessions.
Outcome measures
| Measure |
Oxytocin Session
n=18 Participants
Data from during the Oxytocin Session, regardless of order.
|
Placebo Session
n=18 Participants
Data from during the Placebo saline Session, regardless of order.
|
|---|---|---|
|
Change in Temporal Summation of Pinprick Stimuli
|
0.15 change in ratio of ratings on scales
Standard Deviation 0.63
|
-.02 change in ratio of ratings on scales
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)Population: All participants who completed both sessions.
Pressure pain threshold will be tested using a pressure algometer placed over the dorsal forearm muscles, and pressure will be increased until pain is reported. When pain is reported, the pressure level (in pounds of force) is recorded as the outcome measure.
Outcome measures
| Measure |
Oxytocin Session
n=18 Participants
Data from during the Oxytocin Session, regardless of order.
|
Placebo Session
n=18 Participants
Data from during the Placebo saline Session, regardless of order.
|
|---|---|---|
|
Pressure Pain Threshold
|
0.13 changes in pounds of force
Standard Deviation 1.9
|
0.58 changes in pounds of force
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)Population: All participants who completed both sessions.
Heat pain threshold (HPT) will be tested using a high-quality thermode. To establish HPT, the thermode will be placed on the arm at a baseline temperature of 32 Celsius and will be increased until the stimulus is reported as painful by the participant. The mean of three trials will be taken as the HPT.
Outcome measures
| Measure |
Oxytocin Session
n=18 Participants
Data from during the Oxytocin Session, regardless of order.
|
Placebo Session
n=18 Participants
Data from during the Placebo saline Session, regardless of order.
|
|---|---|---|
|
Heat Pain Threshold
|
0.3 changes in degrees Celsius
Standard Deviation 2.5
|
-0.29 changes in degrees Celsius
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline and time of intervention at both the Oxytocin Session and Placebo Session (Sessions spaced a minimum of 3 days apart)Population: All participants who completed both sessions.
Three 10s trials of the individually calibrated heat stimulus rated 70/100 will be rated using using a "Pain Intensity" Visual Analog Scale rating scale with anchors "No pain" (coded -100) to "Most intense pain imaginable (coded 100)." Higher scores indicate more intense pain (worse outcome).
Outcome measures
| Measure |
Oxytocin Session
n=18 Participants
Data from during the Oxytocin Session, regardless of order.
|
Placebo Session
n=18 Participants
Data from during the Placebo saline Session, regardless of order.
|
|---|---|---|
|
Heat Pain Ratings
|
-15.0 score on a scale
Standard Deviation 43.9
|
1.2 score on a scale
Standard Deviation 23.5
|
Adverse Events
Oxytocin Session
Placebo Session
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place