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Trial record 1 of 1 for:    14980212 [PUBMED-IDS]
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Biological Basis of Individual Variation in Social Cooperation

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ClinicalTrials.gov Identifier: NCT01566539
Recruitment Status : Completed
First Posted : March 29, 2012
Results First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
John Templeton Foundation
Information provided by (Responsible Party):
James K. Rilling, PhD, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Basic Science
Condition Healthy
Interventions Drug: Intranasal Oxytocin (OT) 24 IU
Drug: Intranasal Vasopressin (AVP)
Drug: Intranasal Placebo
Drug: Intranasal Vasopressin (AVP) 40 IU
Drug: Lorazepam
Enrollment 707
Recruitment Details A total of 707 signed the consent form, 449 started the main study period.
Pre-assignment Details The study team did not recruit any participants for the "Anxious and Depressed Subjects - OT", or "Anxious and Depressed Subjects - Placebo" arms.Therefore, these arms have been removed from the record.
Arm/Group Title Healthy Volunteers - Intranasal Vasopressin (AVP) Healthy Volunteers - Intranasal Oxytocin (OT) Healthy Volunteers - Intranasal Placebo Within Subject Group Faces Task - Vasopressin (AVP) Faces Task - Placebo Empathy Task - Oxytocin (OT) Empathy Task - Placebo Healthy Volunteers - Lorazepam
Hide Arm/Group Description

The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.

Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total).

The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.

Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.

The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Some healthy volunteer participants who received drug in their first session will receive placebo in their second session and vice-versa prior to completing the PD task. For each gender, half will receive AVP in one session and placebo in the other session, and half will receive OT in one session and placebo in the second session. In each group, half of the subjects will receive drug first and half will receive placebo first. Additionally, a group of subjects who receive placebo the first time will receive placebo the second time.

Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.

Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total).

Intranasal Placebo: Participants will receive placebo sprays that are pH

Healthy volunteers between the ages of 21-30 years will receive Faces Intranasal Vasopressin (AVP) prior to completing the Faces task during fMRI scanning.

Intranasal Vasopressin (AVP) 40 IU: Participants will self-administer a 0.5 ml solution containing 40 international units (IU) of AVP. 5 puffs in total, each with 4 International Units (IU) AVP.

Healthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and OT at scan 2 prior to completing an empathy task.

Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and placebo at scan 2 prior to completing an empathy task.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Healthy normal men between the ages of 18 and 22 will receive lorazepam prior to completing the Prisoner's Dilemma game task and MRI scan.

Lorazepam: Subjects will take 1.0 mg of lorazepam orally 60 minutes prior to fMRI scan.

Period Title: Main Study Period
Started 101 100 104 0 40 43 30 30 1
Completed 100 100 104 0 40 40 30 30 1
Not Completed 1 0 0 0 0 3 0 0 0
Period Title: Within Subject Group
Started 0 0 0 156 [1] 0 0 0 0 0
Completed 0 0 0 153 [1] 0 0 0 0 0
Not Completed 0 0 0 3 0 0 0 0 0
[1]
Participants can move from Healthy Volunteers-AVP, OT and Placebo groups to the within subject group
Arm/Group Title Healthy Volunteers - Intranasal Vasopressin (AVP) Healthy Volunteers - Intranasal Oxytocin (OT) Healthy Volunteers - Intranasal Placebo Faces Task - Vasopressin (AVP) Faces Task - Placebo Empathy Task - Oxytocin (OT) Empathy Task - Placebo Healthy Volunteers - Lorazepam Total
Hide Arm/Group Description

The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.

Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total).

The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.

Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.

The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Healthy volunteers between the ages of 21-30 years will receive Faces Intranasal Vasopressin (AVP) prior to completing the Faces task during fMRI scanning.

Intranasal Vasopressin (AVP) 40 IU: Participants will self-administer a 0.5 ml solution containing 40 international units (IU) of AVP. 5 puffs in total, each with 4 International Units (IU) AVP.

Healthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and OT at scan 2 prior to completing an empathy task.

Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and placebo at scan 2 prior to completing an empathy task.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Healthy normal men between the ages of 18 and 22 will receive lorazepam prior to completing the Prisoner's Dilemma game task and MRI scan.

Lorazepam: Subjects will take 1.0 mg of lorazepam orally 60 minutes prior to fMRI scan.

Total of all reporting groups
Overall Number of Baseline Participants 101 100 104 40 43 30 30 1 449
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 100 participants 104 participants 40 participants 43 participants 30 participants 30 participants 1 participants 449 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
101
 100.0%
100
 100.0%
104
 100.0%
40
 100.0%
43
 100.0%
30
 100.0%
30
 100.0%
1
 100.0%
449
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants 100 participants 104 participants 40 participants 43 participants 30 participants 30 participants 1 participants 449 participants
Female
52
  51.5%
50
  50.0%
50
  48.1%
20
  50.0%
21
  48.8%
15
  50.0%
15
  50.0%
0
   0.0%
223
  49.7%
Male
49
  48.5%
50
  50.0%
54
  51.9%
20
  50.0%
22
  51.2%
15
  50.0%
15
  50.0%
1
 100.0%
226
  50.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 101 participants 100 participants 104 participants 40 participants 43 participants 30 participants 30 participants 1 participants 449 participants
101 100 104 40 43 30 30 1 449
1.Primary Outcome
Title Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Men
Hide Description The effect of the drug treatment will be assessed by determining differences in brain activation between OT and placebo groups in the right caudate nucleus region during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan.
Time Frame Visit 1 (40-100 Minutes Post-Intervention)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was completed in the Healthy Volunteers - Intranasal Oxytocin (OT) and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with excessive motion, missing data, abnormal brain anatomy or partial data collection were excluded from the analysis.
Arm/Group Title Healthy Volunteers - Intranasal Oxytocin (OT) Healthy Volunteers - Intranasal Placebo
Hide Arm/Group Description:

The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.

Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.

The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Overall Number of Participants Analyzed 43 48
Mean (Standard Error)
Unit of Measure: percent signal change
0.21  (0.03) 0.07  (0.02)
2.Primary Outcome
Title Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Women
Hide Description The effect of the drug treatment will be assessed by determining differences in brain activation between OT and placebo groups in the right caudate nucleus region during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan.
Time Frame Visit 1 (40-100 Minutes Post-Intervention)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was completed in the Healthy Volunteers - Intranasal Oxytocin (OT) and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with excessive motion, missing data, abnormal brain anatomy or partial data collection were excluded from the analysis.
Arm/Group Title Healthy Volunteers - Intranasal Oxytocin (OT) Healthy Volunteers - Intranasal Placebo
Hide Arm/Group Description:

The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.

Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.

The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Overall Number of Participants Analyzed 47 46
Mean (Standard Error)
Unit of Measure: percent signal change
0.04  (0.02) 0.15  (0.02)
3.Primary Outcome
Title Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Men
Hide Description The effect of the drug treatment will be assessed by determining differences in brain activation between AVP and placebo groups in the left insula region during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan.
Time Frame Visit 1 (40-100 Minutes Post-Intervention)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was completed in the Healthy Volunteers - Intranasal Vasopressin (AVP) and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with excessive motion, missing data, abnormal brain anatomy or partial data collection were excluded from the analysis.
Arm/Group Title Healthy Volunteers - Intranasal Vasopressin (AVP) Healthy Volunteers - Intranasal Placebo
Hide Arm/Group Description:

The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.

Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total).

The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Overall Number of Participants Analyzed 44 48
Mean (Standard Error)
Unit of Measure: percent signal change
0.13  (0.02) -0.02  (0.02)
4.Primary Outcome
Title Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Women
Hide Description The effect of the drug treatment will be assessed by determining differences in brain activation between AVP and placebo groups in the left insula during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan.
Time Frame Visit 1 (40-100 Minutes Post-Intervention)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was completed in the Healthy Volunteers - Intranasal Vasopressin (AVP) and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with excessive motion, missing data, abnormal brain anatomy or partial data collection were excluded from the analysis.
Arm/Group Title Healthy Volunteers - Intranasal Vasopressin (AVP) Healthy Volunteers - Intranasal Placebo
Hide Arm/Group Description:

The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.

Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total).

The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Overall Number of Participants Analyzed 49 46
Mean (Standard Error)
Unit of Measure: percent signal change
-0.05  (0.03) 0.10  (0.03)
5.Primary Outcome
Title Within Subject Group: Mean Percent Signal Change in Left Caudate Nucleus in Men and Women
Hide Description The effect of the drug will be assessed by determining changes in brain activation between the visit where the participant received drug and the visit where the participant received PL in the right caudate during reciprocated cooperation in Prisoner Dilemma game while undergoing an fMRI scan.
Time Frame Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was completed for the within subject group per protocol. Subjects with excessive motion during scanning were excluded from the analysis.
Arm/Group Title Within Subject Group
Hide Arm/Group Description:

Some healthy volunteer participants who received drug in their first session will receive placebo in their second session and vice-versa prior to completing the PD task. For each gender, half will receive AVP in one session and placebo in the other session, and half will receive OT in one session and placebo in the second session. In each group, half of the subjects will receive drug first and half will receive placebo first. Additionally, a group of subjects who receive placebo the first time will receive placebo the second time.

Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.

Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total).

Intranasal Placebo: Participants will receive placebo sprays that are pH

Overall Number of Participants Analyzed 57
Mean (Standard Deviation)
Unit of Measure: percent signal change
Oxytocin treatment in men 0.21  (0.19)
Placebo treatment in men 0.19  (0.29)
Oxytocin treatment in women 0.06  (0.21)
Placebo treatment in women 0.10  (0.18)
6.Secondary Outcome
Title Healthy Volunteer Groups: Total Number of Cooperate Choices Made by Men During the Prisoners Dilemma Game
Hide Description The effect of the drug treatments will be assessed by determining the number of cooperative choices made during the prisoner's dilemma game. Participants may make two choices that are considered "cooperative". The higher the total number, the more cooperative choices made.
Time Frame Visit 1 (40-100 Minutes Post-Intervention)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was completed for the Healthy Volunteers - Intranasal Vasopressin (AVP), Healthy Volunteers - Intranasal Oxytocin (OT), and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with missing data were excluded from the analysis.
Arm/Group Title Healthy Volunteers - Intranasal Vasopressin (AVP) Healthy Volunteers - Intranasal Oxytocin (OT) Healthy Volunteers - Intranasal Placebo
Hide Arm/Group Description:

The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.

Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total).

The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.

Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.

The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Overall Number of Participants Analyzed 49 50 53
Mean (Standard Error)
Unit of Measure: number of choices
15.71  (0.98) 16.18  (1.01) 17.68  (0.93)
7.Secondary Outcome
Title Healthy Volunteer Groups: Total Number of Cooperate Choices Made by Women During the Prisoners Dilemma Game
Hide Description The effect of the drug treatments will be assessed by determining the number of cooperative choices made during the prisoner's dilemma game. Participants may make two choices that are considered "cooperative". The higher the total number, the more cooperative choices made.
Time Frame Visit 1 (40-100 Minutes Post-Intervention)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was completed for the Healthy Volunteers - Intranasal Vasopressin (AVP), Healthy Volunteers - Intranasal Oxytocin (OT), and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with missing data were excluded from the analysis.
Arm/Group Title Healthy Volunteers - Intranasal Vasopressin (AVP) Healthy Volunteers - Intranasal Oxytocin (OT) Healthy Volunteers - Intranasal Placebo
Hide Arm/Group Description:

The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.

Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total).

The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.

Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.

The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Overall Number of Participants Analyzed 51 50 50
Mean (Standard Error)
Unit of Measure: number of choices
15.84  (0.76) 18.14  (1.03) 16.92  (0.98)
8.Secondary Outcome
Title Within Subject Group: Mean Difference in Number of Cooperate Choices Made by Male During the Prisoners Dilemma Game
Hide Description The effect of the drug treatments will be assessed by determining the number of cooperative choices made during the prisoner's dilemma game. Participants may make two choices that are considered "cooperative". The higher the total number, the more cooperative choices made.
Time Frame Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was completed for the Within Subject Group per protocol. Subjects with missing data were excluded from the analysis. The difference between OT and PL visits is reported here (OT-PL).
Arm/Group Title Within Subject Group
Hide Arm/Group Description:
Some healthy volunteer participants who received drug in their first session will receive placebo in their second session and vice-versa prior to completing the PD task. For each gender, half will receive AVP in one session and placebo in the other session, and half will receive OT in one session and placebo in the second session. In each group, half of the subjects will receive drug first and half will receive placebo first. Additionally, a group of subjects who receive placebo the first time will receive placebo the second time.
Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: number of choices
-1.10  (5.21)
9.Secondary Outcome
Title Within Subject Group: Mean Difference in Number of Cooperate Choices Made by Female During the Prisoners Dilemma Game
Hide Description The effect of the drug treatments will be assessed by determining the number of cooperative choices made during the prisoner's dilemma game. Participants may make two choices that are considered "cooperative". The higher the total number, the more cooperative choices made.
Time Frame Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was completed for the Within Subject Group per protocol. Subjects with missing data were excluded from the analysis.
Arm/Group Title Within Subject Group
Hide Arm/Group Description:
Some healthy volunteer participants who received drug in their first session will receive placebo in their second session and vice-versa prior to completing the PD task. For each gender, half will receive AVP in one session and placebo in the other session, and half will receive OT in one session and placebo in the second session. In each group, half of the subjects will receive drug first and half will receive placebo first. Additionally, a group of subjects who receive placebo the first time will receive placebo the second time.
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: number of choices
Oxytocin treatment 16.13  (6.87)
Placebo treatment 15.53  (6.70)
10.Secondary Outcome
Title Faces Task Groups: Mean Percent Signal Change in Nucleus Accumbens to Faces in Men
Hide Description The effect of the drug treatment will be assessed by determining differences in brain activation between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.
Time Frame Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was completed for the Faces Task - Vasopressin (AVP) and Faces Task - Placebo groups per protocol. Subjects with missing data were excluded from the analysis.
Arm/Group Title Faces Task - Vasopressin (AVP) Faces Task - Placebo
Hide Arm/Group Description:

Healthy volunteers between the ages of 21-30 years will receive Faces Intranasal Vasopressin (AVP) prior to completing the Faces task during fMRI scanning.

Intranasal Vasopressin (AVP) 40 IU: Participants will self-administer a 0.5 ml solution containing 40 international units (IU) of AVP. 5 puffs in total, each with 4 International Units (IU) AVP.

Healthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: percent signal change
viewing same-sex faces 0.03  (0.30) -0.14  (0.22)
viewing other-sex faces 0.14  (0.33) -0.13  (0.30)
11.Secondary Outcome
Title Faces Task Groups: Mean Percent Signal Change in Nucleus Accumbens to Faces in Women
Hide Description The effect of the drug treatment will be assessed by determining differences in brain activation between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.
Time Frame Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was completed for the Faces Task - Vasopressin (AVP) and Faces Task - Placebo groups per protocol. Subjects with missing data were excluded from the analysis.
Arm/Group Title Faces Task - Vasopressin (AVP) Faces Task - Placebo
Hide Arm/Group Description:

Healthy volunteers between the ages of 21-30 years will receive Faces Intranasal Vasopressin (AVP) prior to completing the Faces task during fMRI scanning.

Intranasal Vasopressin (AVP) 40 IU: Participants will self-administer a 0.5 ml solution containing 40 international units (IU) of AVP. 5 puffs in total, each with 4 International Units (IU) AVP.

Healthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Overall Number of Participants Analyzed 20 19
Mean (Standard Deviation)
Unit of Measure: percent signal change
viewing same-sex faces -0.08  (0.31) 0.12  (0.22)
viewing other-sex faces 0.003  (0.16) 0.13  (0.22)
12.Secondary Outcome
Title Faces Task Groups: Mean Approachability Rating of Faces in Men
Hide Description Approachability is rated by a study specific seven point scale where -3 indicates threatening and unapproachable and +3 indicates friendly and approachable. Participants will rate same-sex and other-sex faces. The effect of the drug treatment will be assessed by determining differences in approachability ratings between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.
Time Frame Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was collected per protocol in the AVP and placebo faces groups.
Arm/Group Title Faces Task - Vasopressin (AVP) Faces Task - Placebo
Hide Arm/Group Description:

Healthy volunteers between the ages of 21-30 years will receive Faces Intranasal Vasopressin (AVP) prior to completing the Faces task during fMRI scanning.

Intranasal Vasopressin (AVP) 40 IU: Participants will self-administer a 0.5 ml solution containing 40 international units (IU) of AVP. 5 puffs in total, each with 4 International Units (IU) AVP.

Healthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
viewing same-sex faces scan 1 0.31  (0.96) -0.06  (0.96)
viewing other-sex faces scan 1 1.00  (1.09) 0.81  (0.92)
viewing same-sex faces scan 2 0.78  (0.88) 0.25  (0.99)
viewing other-sex faces scan 2 1.19  (1.04) 0.89  (0.98)
13.Secondary Outcome
Title Faces Task Group: Mean Approachability Rating of Faces in Women
Hide Description Approachability is rated by a study specific seven point scale where -3 indicates threatening and unapproachable and +3 indicates friendly and approachable. Participants will rate same-sex and other-sex faces. The effect of the drug treatment will be assessed by determining differences in approachability ratings between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.
Time Frame Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was collected per protocol in the AVP and placebo faces groups.
Arm/Group Title Faces Task - Vasopressin (AVP) Faces Task - Placebo
Hide Arm/Group Description:

Healthy volunteers between the ages of 21-30 years will receive Faces Intranasal Vasopressin (AVP) prior to completing the Faces task during fMRI scanning.

Intranasal Vasopressin (AVP) 40 IU: Participants will self-administer a 0.5 ml solution containing 40 international units (IU) of AVP. 5 puffs in total, each with 4 International Units (IU) AVP.

Healthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
viewing same-sex faces scan 1 0.37  (0.57) 0.21  (0.86)
viewing other-sex faces scan 1 -0.04  (0.83) 0.28  (0.61)
viewing same-sex faces scan 2 0.37  (0.57) 0.23  (0.88)
viewing other-sex faces scan 2 0.12  (0.66) 0.22  (0.63)
14.Secondary Outcome
Title Faces Task Groups: Mean Attractiveness Rating of Faces in Men
Hide Description Attractiveness is rated by a study specific seven point scale where -3 indicates least attractive and +3 indicates most attractive. Participants will rate same-sex and other-sex faces. The effect of the drug treatment will be assessed by determining differences in attractiveness ratings between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.
Time Frame Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was collected per protocol in the AVP and placebo faces groups.
Arm/Group Title Faces Task - Vasopressin (AVP) Faces Task - Placebo
Hide Arm/Group Description:

Healthy volunteers between the ages of 21-30 years will receive Faces Intranasal Vasopressin (AVP) prior to completing the Faces task during fMRI scanning.

Intranasal Vasopressin (AVP) 40 IU: Participants will self-administer a 0.5 ml solution containing 40 international units (IU) of AVP. 5 puffs in total, each with 4 International Units (IU) AVP.

Healthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
viewing same-sex faces scan 1 0.35  (0.78) -0.06  (0.77)
viewing other-sex faces scan 1 1.79  (0.58) 1.60  (0.46)
viewing same-sex faces scan 2 0.52  (0.86) -0.08  (0.79)
viewing other-sex faces scan 2 1.70  (0.69) 1.43  (0.64)
15.Secondary Outcome
Title Faces Task Groups: Mean Attractiveness Rating of Faces in Women
Hide Description Attractiveness is rated by a study specific seven point scale where -3 indicates least attractive and +3 indicates most attractive. Participants will rate same-sex and other-sex faces. The effect of the drug treatment will be assessed by determining differences in attractiveness ratings between AVP and PL group when participants are viewing same-sex faces, and when participants are viewing other-sex faces.
Time Frame Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was collected per protocol in the AVP and placebo faces groups.
Arm/Group Title Faces Task - Vasopressin (AVP) Faces Task - Placebo
Hide Arm/Group Description:

Healthy volunteers between the ages of 21-30 years will receive Faces Intranasal Vasopressin (AVP) prior to completing the Faces task during fMRI scanning.

Intranasal Vasopressin (AVP) 40 IU: Participants will self-administer a 0.5 ml solution containing 40 international units (IU) of AVP. 5 puffs in total, each with 4 International Units (IU) AVP.

Healthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
viewing same-sex faces scan 1 1.56  (0.54) 1.02  (0.80)
viewing other-sex faces scan 1 0.55  (1.16) 0.61  (0.62)
viewing same-sex faces scan 2 1.29  (0.68) 0.82  (0.92)
viewing other-sex faces scan 2 0.53  (1.04) 0.28  (0.51)
16.Secondary Outcome
Title Empathy Task Groups: Mean Percent Signal Change in Early Visual Cortex in Response to Animation in Women
Hide Description The effect of the drug treatment will be assessed by determining differences in brain activation between OT and PL group when participants are viewing animations.
Time Frame Visit 1 (40-75 Minutes Post-Intervention), Visit 2 (Up to 1 Month)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was collected per protocol in the OT and placebo empathy task groups.
Arm/Group Title Empathy Task - Oxytocin (OT) Empathy Task - Placebo
Hide Arm/Group Description:

Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and OT at scan 2 prior to completing an empathy task.

Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and placebo at scan 2 prior to completing an empathy task.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: percent signal change
-.910  (.417) -.377  (.656)
17.Secondary Outcome
Title Empathy Task Groups: Mean Percent Signal Change in Early Visual Cortex in Response to Animation in Men
Hide Description The effect of the drug treatment will be assessed by determining differences in brain activation between OT and PL group when participants are viewing animations.
Time Frame Visit 1 (40-75 Minutes Post-Intervention), Visit 2 (Up to 1 Month)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was collected per protocol in the OT and placebo empathy task groups.
Arm/Group Title Empathy Task - Oxytocin (OT) Empathy Task - Placebo
Hide Arm/Group Description:

Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and OT at scan 2 prior to completing an empathy task.

Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and placebo at scan 2 prior to completing an empathy task.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Overall Number of Participants Analyzed 15 15
Mean (Standard Deviation)
Unit of Measure: percent signal change
-.429  (.711) -.382  (1.012)
18.Other Pre-specified Outcome
Title Healthy Volunteers Groups: Mean Vasopressin (AVP) Plasma Level
Hide Description Peripheral levels of AVP will be assessed via assay of plasma collected.
Time Frame Visit 1 (Up to 3 Hours)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was completed in the Healthy Volunteers - Intranasal Vasopressin (AVP), Healthy Volunteers - Intranasal Oxytocin (OT), and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with unreliable or missing data were excluded from the analysis.
Arm/Group Title Healthy Volunteers - Intranasal Vasopressin (AVP) Healthy Volunteers - Intranasal Oxytocin (OT) Healthy Volunteers - Intranasal Placebo
Hide Arm/Group Description:

The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.

Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total).

The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.

Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.

The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Overall Number of Participants Analyzed 27 27 36
Mean (Standard Error)
Unit of Measure: pg/ml
4.5  (0.49) 3.5  (0.34) 3.1  (0.40)
19.Other Pre-specified Outcome
Title Healthy Volunteers Groups: Mean Oxytocin (OT) Plasma Level
Hide Description Peripheral levels of OT will be assessed via assay of plasma collected.
Time Frame Visit 1 (Up to 3 Hours)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was completed in the Healthy Volunteers - Intranasal Vasopressin (AVP), Healthy Volunteers - Intranasal Oxytocin (OT), and Healthy Volunteers - Intranasal Placebo groups per protocol. Subjects with unreliable or missing data were excluded from the analysis.
Arm/Group Title Healthy Volunteers - Intranasal Vasopressin (AVP) Healthy Volunteers - Intranasal Oxytocin (OT) Healthy Volunteers - Intranasal Placebo
Hide Arm/Group Description:

The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.

Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total).

The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.

Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.

The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Overall Number of Participants Analyzed 27 27 36
Mean (Standard Error)
Unit of Measure: pg/ml
120.6  (7.3) 134.7  (10.2) 129.4  (12.2)
20.Other Pre-specified Outcome
Title Healthy Volunteers Groups: Mean Testosterone Plasma Level
Hide Description Peripherals levels of testosterone will be assessed via assay of plasma collected.
Time Frame Visit 1 (Up to 3 Hours)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was completed in the first batch of data collection from Healthy Volunteers - Intranasal Vasopressin (AVP), Healthy Volunteers - Intranasal Oxytocin (OT), and Healthy Volunteers - Intranasal Placebo groups per protocol. Due to the lack of funds, no subsequent analysis has been done on the samples collected.
Arm/Group Title Healthy Volunteers - Intranasal Vasopressin (AVP) Healthy Volunteers - Intranasal Oxytocin (OT) Healthy Volunteers - Intranasal Placebo
Hide Arm/Group Description:

The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.

Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total).

The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.

Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.

The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Overall Number of Participants Analyzed 25 30 31
Mean (Standard Deviation)
Unit of Measure: ng/dl
214.92  (125.42) 475.82  (134.76) 437.99  (160.36)
Time Frame Adverse event were collected throughout the duration of the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Healthy Volunteers - Intranasal Vasopressin (AVP) Healthy Volunteers - Intranasal Oxytocin (OT) Healthy Volunteers - Intranasal Placebo Within Subject Group Faces Task - Vasopressin (AVP) Faces Task - Placebo Empathy Task - Oxytocin (OT) Empathy Task - Placebo Healthy Volunteers - Lorazepam
Hide Arm/Group Description

The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.

Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total).

The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.

Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.

The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Some healthy volunteer participants who received drug in their first session will receive placebo in their second session and vice-versa prior to completing the PD task. For each gender, half will receive AVP in one session and placebo in the other session, and half will receive OT in one session and placebo in the second session. In each group, half of the subjects will receive drug first and half will receive placebo first. Additionally, a group of subjects who receive placebo the first time will receive placebo the second time.

Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.

Intranasal Vasopressin (AVP): Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total).

Intranasal Placebo: Participants will receive placebo sprays that are pH

Healthy volunteers between the ages of 21-30 years will receive Faces Intranasal Vasopressin (AVP) prior to completing the Faces task during fMRI scanning.

Intranasal Vasopressin (AVP) 40 IU: Participants will self-administer a 0.5 ml solution containing 40 international units (IU) of AVP. 5 puffs in total, each with 4 International Units (IU) AVP.

Healthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and OT at scan 2 prior to completing an empathy task.

Intranasal Oxytocin (OT) 24 IU: Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Healthy volunteers between the ages of 18-30 years will receive placebo at scan 1 and placebo at scan 2 prior to completing an empathy task.

Intranasal Placebo: Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.

Healthy normal men between the ages of 18 and 22 will receive lorazepam prior to completing the Prisoner's Dilemma game task and MRI scan.

Lorazepam: Subjects will take 1.0 mg of lorazepam orally 60 minutes prior to fMRI scan.

All-Cause Mortality
Healthy Volunteers - Intranasal Vasopressin (AVP) Healthy Volunteers - Intranasal Oxytocin (OT) Healthy Volunteers - Intranasal Placebo Within Subject Group Faces Task - Vasopressin (AVP) Faces Task - Placebo Empathy Task - Oxytocin (OT) Empathy Task - Placebo Healthy Volunteers - Lorazepam
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/101 (0.00%)      0/100 (0.00%)      0/104 (0.00%)      0/156 (0.00%)      0/40 (0.00%)      0/43 (0.00%)      0/30 (0.00%)      0/30 (0.00%)      0/1 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Healthy Volunteers - Intranasal Vasopressin (AVP) Healthy Volunteers - Intranasal Oxytocin (OT) Healthy Volunteers - Intranasal Placebo Within Subject Group Faces Task - Vasopressin (AVP) Faces Task - Placebo Empathy Task - Oxytocin (OT) Empathy Task - Placebo Healthy Volunteers - Lorazepam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/101 (0.00%)      0/100 (0.00%)      0/104 (0.00%)      0/156 (0.00%)      0/40 (0.00%)      0/43 (0.00%)      0/30 (0.00%)      0/30 (0.00%)      0/1 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Healthy Volunteers - Intranasal Vasopressin (AVP) Healthy Volunteers - Intranasal Oxytocin (OT) Healthy Volunteers - Intranasal Placebo Within Subject Group Faces Task - Vasopressin (AVP) Faces Task - Placebo Empathy Task - Oxytocin (OT) Empathy Task - Placebo Healthy Volunteers - Lorazepam
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/101 (2.97%)      4/100 (4.00%)      12/104 (11.54%)      0/156 (0.00%)      0/40 (0.00%)      1/43 (2.33%)      0/30 (0.00%)      0/30 (0.00%)      0/1 (0.00%)    
General disorders                   
fever  [1]  0/101 (0.00%)  0 0/100 (0.00%)  0 1/104 (0.96%)  1 0/156 (0.00%)  0 0/40 (0.00%)  0 0/43 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/1 (0.00%)  0
felt faint after blood draw  [2]  0/101 (0.00%)  0 1/100 (1.00%)  1 0/104 (0.00%)  0 0/156 (0.00%)  0 0/40 (0.00%)  0 0/43 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/1 (0.00%)  0
nose bleed  [3]  1/101 (0.99%)  1 0/100 (0.00%)  0 0/104 (0.00%)  0 0/156 (0.00%)  0 0/40 (0.00%)  0 0/43 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/1 (0.00%)  0
nausea  [4]  0/101 (0.00%)  0 0/100 (0.00%)  0 1/104 (0.96%)  1 0/156 (0.00%)  0 0/40 (0.00%)  0 0/43 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/1 (0.00%)  0
Psychiatric disorders                   
claustrophobia  [5]  0/101 (0.00%)  0 0/100 (0.00%)  0 1/104 (0.96%)  1 0/156 (0.00%)  0 0/40 (0.00%)  0 0/43 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/1 (0.00%)  0
Vascular disorders                   
high blood pressure or heart rate post-drug administration  [6]  3/101 (2.97%)  3 3/100 (3.00%)  3 9/104 (8.65%)  9 0/156 (0.00%)  0 0/40 (0.00%)  0 1/43 (2.33%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/1 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Participant came in with a fever and was scheduled for later date. No procedures were done to the participant.
[2]
subject felt faint after first blood draw. After resting, subject recovered and the study continued.
[3]
subject experience nose bleed prior to drug administration, probably due to dry weather.
[4]
Subject experience nausea after drug administration.The subject believed it was due to hunger. Study physician was contacted and subject was provided some food. Once fed, the nausea subsided. He reported no side-effects.
[5]
participants have claustrophobia and cannot enter a MRI scanner
[6]
Subjects experience high blood pressure (above 140/90) or heart rate (above 100 bpm) post drug administration. Per protocol, subjects rested for 5-10 minutes and blood pressure and heart rate was retaken. They returned normal. Study proceeded.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. James Rilling
Organization: Emory University
Phone: 404-727-3062
Responsible Party: James K. Rilling, PhD, Emory University
ClinicalTrials.gov Identifier: NCT01566539     History of Changes
Other Study ID Numbers: IRB00007905
1R01MH084068-01A1 ( U.S. NIH Grant/Contract )
MH087721-01A1 ( Other Identifier: NIMH )
First Submitted: March 26, 2012
First Posted: March 29, 2012
Results First Submitted: July 21, 2017
Results First Posted: September 25, 2017
Last Update Posted: September 25, 2017