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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 707 signed the consent form, 449 started the main study period.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Healthy Volunteers - Intranasal Vasopressin (AVP)

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).

Healthy Volunteers - Intranasal Oxytocin (OT)

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.

Healthy Volunteers - Intranasal Placebo

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.

Within Subject Group

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

Faces Task - Vasopressin (AVP)

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.

Faces Task - Placebo

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.

Empathy Task - Oxytocin (OT)

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.

Empathy Task - Placebo

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 Volunteers - Lorazepam

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.


Participant Flow for 2 periods

Period 1:   Main Study Period
    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
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 2:   Within Subject Group
    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
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



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Healthy Volunteers - Intranasal Vasopressin (AVP)

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).

Healthy Volunteers - Intranasal Oxytocin (OT)

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.

Healthy Volunteers - Intranasal Placebo

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.

Faces Task - Vasopressin (AVP)

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.

Faces Task - Placebo

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.

Empathy Task - Oxytocin (OT)

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.

Empathy Task - Placebo

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 Volunteers - Lorazepam

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 Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 101   100   104   40   43   30   30   1   449 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of 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 
[Units: Participants]
                 
United States   101   100   104   40   43   30   30   1   449 


  Outcome Measures

1.  Primary:   Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Men   [ Time Frame: Visit 1 (40-100 Minutes Post-Intervention) ]

2.  Primary:   Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Women   [ Time Frame: Visit 1 (40-100 Minutes Post-Intervention) ]

3.  Primary:   Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Men   [ Time Frame: Visit 1 (40-100 Minutes Post-Intervention) ]

4.  Primary:   Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Women   [ Time Frame: Visit 1 (40-100 Minutes Post-Intervention) ]

5.  Primary:   Within Subject Group: Mean Percent Signal Change in Left Caudate Nucleus in Men and Women   [ Time Frame: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks) ]

6.  Secondary:   Healthy Volunteer Groups: Total Number of Cooperate Choices Made by Men During the Prisoners Dilemma Game   [ Time Frame: Visit 1 (40-100 Minutes Post-Intervention) ]

7.  Secondary:   Healthy Volunteer Groups: Total Number of Cooperate Choices Made by Women During the Prisoners Dilemma Game   [ Time Frame: Visit 1 (40-100 Minutes Post-Intervention) ]

8.  Secondary:   Within Subject Group: Mean Difference in Number of Cooperate Choices Made by Male During the Prisoners Dilemma Game   [ Time Frame: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks) ]

9.  Secondary:   Within Subject Group: Mean Difference in Number of Cooperate Choices Made by Female During the Prisoners Dilemma Game   [ Time Frame: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks) ]

10.  Secondary:   Faces Task Groups: Mean Percent Signal Change in Nucleus Accumbens to Faces in Men   [ Time Frame: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days) ]

11.  Secondary:   Faces Task Groups: Mean Percent Signal Change in Nucleus Accumbens to Faces in Women   [ Time Frame: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days) ]

12.  Secondary:   Faces Task Groups: Mean Approachability Rating of Faces in Men   [ Time Frame: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days) ]

13.  Secondary:   Faces Task Group: Mean Approachability Rating of Faces in Women   [ Time Frame: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days) ]

14.  Secondary:   Faces Task Groups: Mean Attractiveness Rating of Faces in Men   [ Time Frame: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days) ]

15.  Secondary:   Faces Task Groups: Mean Attractiveness Rating of Faces in Women   [ Time Frame: Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days) ]

16.  Secondary:   Empathy Task Groups: Mean Percent Signal Change in Early Visual Cortex in Response to Animation in Women   [ Time Frame: Visit 1 (40-75 Minutes Post-Intervention), Visit 2 (Up to 1 Month) ]

17.  Secondary:   Empathy Task Groups: Mean Percent Signal Change in Early Visual Cortex in Response to Animation in Men   [ Time Frame: Visit 1 (40-75 Minutes Post-Intervention), Visit 2 (Up to 1 Month) ]

18.  Other Pre-specified:   Healthy Volunteers Groups: Mean Vasopressin (AVP) Plasma Level   [ Time Frame: Visit 1 (Up to 3 Hours) ]

19.  Other Pre-specified:   Healthy Volunteers Groups: Mean Oxytocin (OT) Plasma Level   [ Time Frame: Visit 1 (Up to 3 Hours) ]

20.  Other Pre-specified:   Healthy Volunteers Groups: Mean Testosterone Plasma Level   [ Time Frame: Visit 1 (Up to 3 Hours) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: jrillin@emory.edu


Publications:

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