Trial Outcomes & Findings for Vasopressin and Pain Perception in the Brain (NCT NCT03446456)
NCT ID: NCT03446456
Last Updated: 2025-05-20
Results Overview
Blood oxygenation level dependent (BOLD) responses will allow the identification of relative activation/deactivation in the brain as a result of events (e.g. painful stimulations) that will be given during the experiment. Changes in the Percentage of BOLD signal are calculated as the BOLD signal in the right supplementary motor area during the 20-second heat pain divided by the whole-brain average BOLD signal during that 20-second heat pain.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Day 2, the average of 24 trials of painful stimulations with each stimulation lasting 20 seconds
Results posted on
2025-05-20
Participant Flow
Participant milestones
| Measure |
Saline
Under direction of a research team member, participants will self-administer intranasal normal saline shortly before beginning the fMRI experiment.
Investigators, staff, and participants were blinded to the treatment options. Each of the agents will be administrated by means of a nasal spray. Participants will be instructed by a nurse/PI to self-administer the nasal spray as follows: one spray in each nostril alternating sides, 30 seconds apart for a total of two sprays per nostril.
Saline: Intranasal saline will serve as a placebo for participants in the Saline Arm
Observational learning: During the observational learning intervention, participants will learn the experience of analgesia in another person via a video. Participants will learn the analgesia nature of the placebo cream and the neutral nature of the control cream.
|
Arginine Vasopressin
Under direction of a research team member, participants will self-administer intranasal vasopressin shortly before beginning the fMRI experiment. The of AVP will be 40IU. The quantity per unit (1 mL) of Arg8-vasopressin synthetic, manufactured by Polypeptide Group Inc. (http://www.polypeptide.com) was 0.323 mg. This amount was diluted in 0.9% sodium chloride (B. Broun Medical Inc.).
A random allocation sequence will be independently generated by the UM Pharmacy. The Principal investigator will call for each experiment. Participants will be first stratified for sex and then randomized to saline (0.4 mL) or vasopressin (40 IU) group, respectively.
Arginine vasopressin: Intranasal vasopressin will be administered shortly before the fMRI experiment.
Observational learning: During the observational learning intervention, participants will learn the experience of analgesia in another person via a video. Participants will learn the analgesia nature of the placebo cream and the neutral nature of the control cream.
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|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Saline
Under direction of a research team member, participants will self-administer intranasal normal saline shortly before beginning the fMRI experiment.
Investigators, staff, and participants were blinded to the treatment options. Each of the agents will be administrated by means of a nasal spray. Participants will be instructed by a nurse/PI to self-administer the nasal spray as follows: one spray in each nostril alternating sides, 30 seconds apart for a total of two sprays per nostril.
Saline: Intranasal saline will serve as a placebo for participants in the Saline Arm
Observational learning: During the observational learning intervention, participants will learn the experience of analgesia in another person via a video. Participants will learn the analgesia nature of the placebo cream and the neutral nature of the control cream.
|
Arginine Vasopressin
Under direction of a research team member, participants will self-administer intranasal vasopressin shortly before beginning the fMRI experiment. The of AVP will be 40IU. The quantity per unit (1 mL) of Arg8-vasopressin synthetic, manufactured by Polypeptide Group Inc. (http://www.polypeptide.com) was 0.323 mg. This amount was diluted in 0.9% sodium chloride (B. Broun Medical Inc.).
A random allocation sequence will be independently generated by the UM Pharmacy. The Principal investigator will call for each experiment. Participants will be first stratified for sex and then randomized to saline (0.4 mL) or vasopressin (40 IU) group, respectively.
Arginine vasopressin: Intranasal vasopressin will be administered shortly before the fMRI experiment.
Observational learning: During the observational learning intervention, participants will learn the experience of analgesia in another person via a video. Participants will learn the analgesia nature of the placebo cream and the neutral nature of the control cream.
|
|---|---|---|
|
Overall Study
Participant was in a previous social learning study (exclusion criteria)
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Participant failed the toxicology test
|
1
|
0
|
|
Overall Study
Break down of the experimental equipment
|
1
|
0
|
Baseline Characteristics
Vasopressin and Pain Perception in the Brain
Baseline characteristics by cohort
| Measure |
Saline
n=16 Participants
Under direction of a research team member, participants will self-administer intranasal normal saline shortly before beginning the fMRI experiment.
Investigators, staff, and participants were blinded to the treatment options. Each of the agents will be administrated by means of a nasal spray. Participants will be instructed by a nurse/PI to self-administer the nasal spray as follows: one spray in each nostril alternating sides, 30 seconds apart for a total of two sprays per nostril.
Saline: Intranasal saline will serve as a placebo for participants in the Saline Arm
Observational learning: During the observational learning intervention, participants will learn the experience of analgesia in another person via a video. Participants will learn the analgesia nature of the placebo cream and the neutral nature of the control cream.
|
Arginine Vasopressin
n=16 Participants
Under direction of a research team member, participants will self-administer intranasal vasopressin shortly before beginning the fMRI experiment. The of AVP will be 40IU. The quantity per unit (1 mL) of Arg8-vasopressin synthetic, manufactured by Polypeptide Group Inc. (http://www.polypeptide.com) was 0.323 mg. This amount was diluted in 0.9% sodium chloride (B. Broun Medical Inc.).
A random allocation sequence will be independently generated by the UM Pharmacy. The Principal investigator will call for each experiment. Participants will be first stratified for sex and then randomized to saline (0.4 mL) or vasopressin (40 IU) group, respectively.
Arginine vasopressin: Intranasal vasopressin will be administered shortly before the fMRI experiment.
Observational learning: During the observational learning intervention, participants will learn the experience of analgesia in another person via a video. Participants will learn the analgesia nature of the placebo cream and the neutral nature of the control cream.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
28.25 years
STANDARD_DEVIATION 7.43 • n=5 Participants
|
25.44 years
STANDARD_DEVIATION 5.75 • n=7 Participants
|
26.84 years
STANDARD_DEVIATION 6.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 2, the average of 24 trials of painful stimulations with each stimulation lasting 20 secondsBlood oxygenation level dependent (BOLD) responses will allow the identification of relative activation/deactivation in the brain as a result of events (e.g. painful stimulations) that will be given during the experiment. Changes in the Percentage of BOLD signal are calculated as the BOLD signal in the right supplementary motor area during the 20-second heat pain divided by the whole-brain average BOLD signal during that 20-second heat pain.
Outcome measures
| Measure |
Saline
n=16 Participants
Under direction of a research team member, participants will self-administer intranasal normal saline shortly before beginning the fMRI experiment.
Investigators, staff, and participants were blinded to the treatment options. Each of the agents will be administrated by means of a nasal spray. Participants will be instructed by a nurse/PI to self-administer the nasal spray as follows: one spray in each nostril alternating sides, 30 seconds apart for a total of two sprays per nostril.
Saline: Intranasal saline will serve as a placebo for participants in the Saline Arm
Observational learning: During the observational learning intervention, participants will learn the experience of analgesia in another person via a video. Participants will learn the analgesia nature of the placebo cream and the neutral nature of the control cream.
|
Arginine Vasopressin
n=16 Participants
Under direction of a research team member, participants will self-administer intranasal vasopressin shortly before beginning the fMRI experiment. The of AVP will be 40IU. The quantity per unit (1 mL) of Arg8-vasopressin synthetic, manufactured by Polypeptide Group Inc. (http://www.polypeptide.com) was 0.323 mg. This amount was diluted in 0.9% sodium chloride (B. Broun Medical Inc.).
A random allocation sequence will be independently generated by the UM Pharmacy. The Principal investigator will call for each experiment. Participants will be first stratified for sex and then randomized to saline (0.4 mL) or vasopressin (40 IU) group, respectively.
Arginine vasopressin: Intranasal vasopressin will be administered shortly before the fMRI experiment.
Observational learning: During the observational learning intervention, participants will learn the experience of analgesia in another person via a video. Participants will learn the analgesia nature of the placebo cream and the neutral nature of the control cream.
|
|---|---|---|
|
Change in BOLD Singal in Supplementary Motor Area Compared to Whole Brain Average During the Painful Stimulation
|
0.485 percentage of BOLD signal change
Standard Deviation 0.271
|
0.482 percentage of BOLD signal change
Standard Deviation 0.387
|
SECONDARY outcome
Timeframe: Day 1 (calibration)On Day 1, the heating temperature was calibrated to the individual level. The heating temperature corresponding to 50 out of 100 visual analog scale pain ratings was selected as the testing temperature for day 2 (test).
Outcome measures
| Measure |
Saline
n=16 Participants
Under direction of a research team member, participants will self-administer intranasal normal saline shortly before beginning the fMRI experiment.
Investigators, staff, and participants were blinded to the treatment options. Each of the agents will be administrated by means of a nasal spray. Participants will be instructed by a nurse/PI to self-administer the nasal spray as follows: one spray in each nostril alternating sides, 30 seconds apart for a total of two sprays per nostril.
Saline: Intranasal saline will serve as a placebo for participants in the Saline Arm
Observational learning: During the observational learning intervention, participants will learn the experience of analgesia in another person via a video. Participants will learn the analgesia nature of the placebo cream and the neutral nature of the control cream.
|
Arginine Vasopressin
n=16 Participants
Under direction of a research team member, participants will self-administer intranasal vasopressin shortly before beginning the fMRI experiment. The of AVP will be 40IU. The quantity per unit (1 mL) of Arg8-vasopressin synthetic, manufactured by Polypeptide Group Inc. (http://www.polypeptide.com) was 0.323 mg. This amount was diluted in 0.9% sodium chloride (B. Broun Medical Inc.).
A random allocation sequence will be independently generated by the UM Pharmacy. The Principal investigator will call for each experiment. Participants will be first stratified for sex and then randomized to saline (0.4 mL) or vasopressin (40 IU) group, respectively.
Arginine vasopressin: Intranasal vasopressin will be administered shortly before the fMRI experiment.
Observational learning: During the observational learning intervention, participants will learn the experience of analgesia in another person via a video. Participants will learn the analgesia nature of the placebo cream and the neutral nature of the control cream.
|
|---|---|---|
|
Heating Temperature
|
44.16 celsius degree
Standard Deviation 0.77
|
44.44 celsius degree
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Day 2 (test)Participants will provide their pain on a Visual Analogue Scale raging from 0=no pain to 100= maximum unbearable pain. Normal value will be absence of pain.
Outcome measures
| Measure |
Saline
n=16 Participants
Under direction of a research team member, participants will self-administer intranasal normal saline shortly before beginning the fMRI experiment.
Investigators, staff, and participants were blinded to the treatment options. Each of the agents will be administrated by means of a nasal spray. Participants will be instructed by a nurse/PI to self-administer the nasal spray as follows: one spray in each nostril alternating sides, 30 seconds apart for a total of two sprays per nostril.
Saline: Intranasal saline will serve as a placebo for participants in the Saline Arm
Observational learning: During the observational learning intervention, participants will learn the experience of analgesia in another person via a video. Participants will learn the analgesia nature of the placebo cream and the neutral nature of the control cream.
|
Arginine Vasopressin
n=16 Participants
Under direction of a research team member, participants will self-administer intranasal vasopressin shortly before beginning the fMRI experiment. The of AVP will be 40IU. The quantity per unit (1 mL) of Arg8-vasopressin synthetic, manufactured by Polypeptide Group Inc. (http://www.polypeptide.com) was 0.323 mg. This amount was diluted in 0.9% sodium chloride (B. Broun Medical Inc.).
A random allocation sequence will be independently generated by the UM Pharmacy. The Principal investigator will call for each experiment. Participants will be first stratified for sex and then randomized to saline (0.4 mL) or vasopressin (40 IU) group, respectively.
Arginine vasopressin: Intranasal vasopressin will be administered shortly before the fMRI experiment.
Observational learning: During the observational learning intervention, participants will learn the experience of analgesia in another person via a video. Participants will learn the analgesia nature of the placebo cream and the neutral nature of the control cream.
|
|---|---|---|
|
Pain Ratings
|
44.84 units on a scale
Standard Deviation 24.49
|
47.19 units on a scale
Standard Deviation 26.27
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1The IAT is a behavioral test that examines racial biases via measuring the strength of associations between concepts (e.g., African-American, Asian, White) and evaluations (good, bad). Participants were asked to press a response key when they saw images (people) or words (good/bad) on the screen. Response latencies (RL) were measured in milliseconds using E-prime as the reaction time to press the response key. An RL difference (D) score was calculated as 1) Compute the standard deviation (SD) of RL from overall trials; 2) M1 is the mean of RL in the condition where "White" and "good" share the same response key. M2 is the mean of RL in the condition where "African-American/Asian people" and "good" share the same response key; 3) D = (M2-M1)/SD. The D score ranges from -2 to +2. Positive values indicate a racial preference for White people. Negative values indicate a racial preference for African-American/Black or Asian people. A value close to 0 indicates no racial preference.
Outcome measures
| Measure |
Saline
n=16 Participants
Under direction of a research team member, participants will self-administer intranasal normal saline shortly before beginning the fMRI experiment.
Investigators, staff, and participants were blinded to the treatment options. Each of the agents will be administrated by means of a nasal spray. Participants will be instructed by a nurse/PI to self-administer the nasal spray as follows: one spray in each nostril alternating sides, 30 seconds apart for a total of two sprays per nostril.
Saline: Intranasal saline will serve as a placebo for participants in the Saline Arm
Observational learning: During the observational learning intervention, participants will learn the experience of analgesia in another person via a video. Participants will learn the analgesia nature of the placebo cream and the neutral nature of the control cream.
|
Arginine Vasopressin
n=16 Participants
Under direction of a research team member, participants will self-administer intranasal vasopressin shortly before beginning the fMRI experiment. The of AVP will be 40IU. The quantity per unit (1 mL) of Arg8-vasopressin synthetic, manufactured by Polypeptide Group Inc. (http://www.polypeptide.com) was 0.323 mg. This amount was diluted in 0.9% sodium chloride (B. Broun Medical Inc.).
A random allocation sequence will be independently generated by the UM Pharmacy. The Principal investigator will call for each experiment. Participants will be first stratified for sex and then randomized to saline (0.4 mL) or vasopressin (40 IU) group, respectively.
Arginine vasopressin: Intranasal vasopressin will be administered shortly before the fMRI experiment.
Observational learning: During the observational learning intervention, participants will learn the experience of analgesia in another person via a video. Participants will learn the analgesia nature of the placebo cream and the neutral nature of the control cream.
|
|---|---|---|
|
Implicit Association Test (IAT) Response Latency Difference
|
0.03 difference score
Standard Deviation 0.37
|
0.07 difference score
Standard Deviation 0.32
|
Adverse Events
Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arginine Vasopressin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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