Biological Basis of Individual Variation in Social Cooperation

NCT01566539 | Completed Results DMC

• 3 other identifiers: IRB000079051R01MH084068-01A1MH087721-01A1
• Study Type: interventional
• Target: 707
• Locations: 1 country
• Sites: 2

Brief Summary

The project has three overall objectives. The first is to determine whether and how administration of intranasal oxytocin (OT) and intranasal vasopressin (AVP) influence cooperative decision-making and neural responses to cooperative and un-cooperative social interactions. The second is to determine whether and how intranasal vasopressin influences subjective evaluations of and neural responses to same and opposite-sex face stimuli and to determine if any of these effects persist beyond the period of AVP exposure. The third objective is to determine if intranasal OT influences empathy-related behavior and associated brain activity.

Conditions

Healthy

Keywords

Social cooperation; Oxytocin; Vasopressin; Prisoner's Dilemma game; Empathy; fMRI

Outcome Measures

Primary Outcomes (5)

• Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Men

  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.

  Visit 1 (40-100 Minutes Post-Intervention)

• Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Women

  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.

  Visit 1 (40-100 Minutes Post-Intervention)

• Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Men

  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.

  Visit 1 (40-100 Minutes Post-Intervention)

• Healthy Volunteers-AVP, Placebo: Mean Percent Signal Change in Left Insula in Women

  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.

  Visit 1 (40-100 Minutes Post-Intervention)

• Within Subject Group: Mean Percent Signal Change in Left Caudate Nucleus in Men and Women

  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.

  Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)

Secondary Outcomes (12)

• Healthy Volunteer Groups: Total Number of Cooperate Choices Made by Men During the Prisoners Dilemma Game

  Visit 1 (40-100 Minutes Post-Intervention)

• Healthy Volunteer Groups: Total Number of Cooperate Choices Made by Women During the Prisoners Dilemma Game

  Visit 1 (40-100 Minutes Post-Intervention)

• Within Subject Group: Mean Difference in Number of Cooperate Choices Made by Male During the Prisoners Dilemma Game

  Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)

• Within Subject Group: Mean Difference in Number of Cooperate Choices Made by Female During the Prisoners Dilemma Game

  Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks)

• Faces Task Groups: Mean Percent Signal Change in Nucleus Accumbens to Faces in Men

  Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days)

Other Outcomes (3)

• Healthy Volunteers Groups: Mean Vasopressin (AVP) Plasma Level

  Visit 1 (Up to 3 Hours)

• Healthy Volunteers Groups: Mean Oxytocin (OT) Plasma Level

  Visit 1 (Up to 3 Hours)

• Healthy Volunteers Groups: Mean Testosterone Plasma Level

  Visit 1 (Up to 3 Hours)

Study Arms (11)

Healthy Volunteers - Intranasal Vasopressin (AVP)

EXPERIMENTAL

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

Drug: Intranasal Vasopressin (AVP)

Healthy Volunteers - Intranasal Oxytocin (OT)

EXPERIMENTAL

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

Drug: Intranasal Oxytocin (OT) 24 IU

Healthy Volunteers - Intranasal Placebo

PLACEBO COMPARATOR

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

Drug: Intranasal Placebo

Within Subject Group

EXPERIMENTAL

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.

Drug: Intranasal Oxytocin (OT) 24 IU; Drug: Intranasal Vasopressin (AVP); Drug: Intranasal Placebo

Faces Task - Vasopressin (AVP)

EXPERIMENTAL

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

Drug: Intranasal Vasopressin (AVP) 40 IU

Faces Task - Placebo

PLACEBO COMPARATOR

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

Drug: Intranasal Placebo

Empathy Task - Oxytocin (OT)

EXPERIMENTAL

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.

Drug: Intranasal Oxytocin (OT) 24 IU; Drug: Intranasal Placebo

Empathy Task - Placebo

PLACEBO COMPARATOR

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.

Drug: Intranasal Placebo

Anxious and Depressed Subjects - OT

EXPERIMENTAL

Depressed or anxious men between the ages of 18 and 22 will receive intranasal OT prior to completing the Prisoner's Dilemma game task and MRI scan.

Drug: Intranasal Oxytocin (OT) 24 IU

Anxious and Depressed Subjects - Placebo

PLACEBO COMPARATOR

Depressed or anxious men between the ages of 18 and 22 will receive intranasal placebo prior to completing the Prisoner's Dilemma game task and MRI scan.

Drug: Intranasal Placebo

Healthy Volunteers - Lorazepam

EXPERIMENTAL

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.

Drug: Lorazepam

Interventions

Intranasal Oxytocin (OT) 24 IU DRUG

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.

Also known as: Oxytocin: Syntocinon Nasal Spray

Anxious and Depressed Subjects - OT; Empathy Task - Oxytocin (OT); Healthy Volunteers - Intranasal Oxytocin (OT); Within Subject Group

Intranasal Vasopressin (AVP) DRUG

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 Vasopressin (AVP); Within Subject Group

Intranasal Placebo DRUG

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

Anxious and Depressed Subjects - Placebo; Empathy Task - Oxytocin (OT); Empathy Task - Placebo; Faces Task - Placebo; Healthy Volunteers - Intranasal Placebo; Within Subject Group

Intranasal Vasopressin (AVP) 40 IU DRUG

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 - Vasopressin (AVP)

Lorazepam DRUG

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

Healthy Volunteers - Lorazepam

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• for Faces component
• Normal or corrected-to-normal vision of 20/40
• Unmedicated depressed or anxious men between 18-22 years of age for Anxious and Depressed component

You may not qualify if:

• Pregnancy, recent birth, or breastfeeding
• History of seizures
• Neurological Disorder
• Current psychiatric disorder
• Previous psychiatric disorder (can be included as discretion of PI)
• Current use of psychoactive drugs
• Previous use of psychoactive drugs (can be included as discretion of PI)
• Previous head trauma (can be included at discretion of PI)
• Alcoholism or substance abuse
• Hypertension
• Cardiovascular Disease
• Nephritis
• Diabetes
• Endocrine disease or malignancy
• Asthma (can be included as discretion of PI, if episodes are infrequent, nonmedicated, and no active problems at time of study)

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator
• John Templeton Foundation: collaborator

Study Sites (2)

Emory University Hospital

Atlanta, Georgia, 30307, United States

Location

Emory University 1462 Clifton Rd

Atlanta, Georgia, 30322, United States

Location

Related Publications (6)

• Kosfeld M, Heinrichs M, Zak PJ, Fischbacher U, Fehr E. Oxytocin increases trust in humans. Nature. 2005 Jun 2;435(7042):673-6. doi: 10.1038/nature03701.

  PMID: 15931222 BACKGROUND

• Fisher H, Aron A, Brown LL. Romantic love: an fMRI study of a neural mechanism for mate choice. J Comp Neurol. 2005 Dec 5;493(1):58-62. doi: 10.1002/cne.20772.

  PMID: 16255001 BACKGROUND

• Thompson RR, George K, Walton JC, Orr SP, Benson J. Sex-specific influences of vasopressin on human social communication. Proc Natl Acad Sci U S A. 2006 May 16;103(20):7889-94. doi: 10.1073/pnas.0600406103. Epub 2006 May 8.

  PMID: 16682649 BACKGROUND

• Vrticka P, Andersson F, Sander D, Vuilleumier P. Memory for friends or foes: the social context of past encounters with faces modulates their subsequent neural traces in the brain. Soc Neurosci. 2009;4(5):384-401. doi: 10.1080/17470910902941793. Epub 2009 Jul 27.

  PMID: 19637101 BACKGROUND

• Singer T, Kiebel SJ, Winston JS, Dolan RJ, Frith CD. Brain responses to the acquired moral status of faces. Neuron. 2004 Feb 19;41(4):653-62. doi: 10.1016/s0896-6273(04)00014-5.

  PMID: 14980212 BACKGROUND

• Guroglu B, Haselager GJ, van Lieshout CF, Takashima A, Rijpkema M, Fernandez G. Why are friends special? Implementing a social interaction simulation task to probe the neural correlates of friendship. Neuroimage. 2008 Jan 15;39(2):903-10. doi: 10.1016/j.neuroimage.2007.09.007. Epub 2007 Sep 15.

  PMID: 17964185 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Insipidus

Interventions

Lorazepam

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. James Rilling
• Organization: Emory University

jrillin@emory.edu

404-727-3062

Study Officials

• James K Rilling, Ph.D.

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 26, 2012
• First Posted: March 29, 2012
• Study Start: April 1, 2008
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: September 25, 2017
• Results First Posted: September 25, 2017

Record last verified: 2017-09

Locations

US (2)