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Biological Basis of Individual Variation in Social Cooperation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01566539
First Posted: March 29, 2012
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Mental Health (NIMH)
John Templeton Foundation
Information provided by (Responsible Party):
James K. Rilling, PhD, Emory University
  Purpose
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.

Condition Intervention
Healthy Drug: Intranasal Oxytocin (OT) 24 IU Drug: Intranasal Vasopressin (AVP) Drug: Intranasal Placebo Drug: Intranasal Vasopressin (AVP) 40 IU Drug: Lorazepam

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: The Biological Basis of Individual Variation in Social Cooperation

Resource links provided by NLM:


Further study details as provided by James K. Rilling, PhD, Emory University:

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

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

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

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

  • 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) ]
    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.


Secondary Outcome Measures:
  • 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) ]
    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.

  • 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) ]
    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.

  • 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) ]
    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.

  • 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) ]
    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.

  • 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) ]
    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.

  • 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) ]
    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.

  • 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) ]
    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.

  • 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) ]
    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.

  • 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) ]
    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.

  • 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) ]
    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.

  • 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) ]
    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.

  • 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) ]
    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.


Other Outcome Measures:
  • Healthy Volunteers Groups: Mean Vasopressin (AVP) Plasma Level [ Time Frame: Visit 1 (Up to 3 Hours) ]
    Peripheral levels of AVP will be assessed via assay of plasma collected.

  • Healthy Volunteers Groups: Mean Oxytocin (OT) Plasma Level [ Time Frame: Visit 1 (Up to 3 Hours) ]
    Peripheral levels of OT will be assessed via assay of plasma collected.

  • Healthy Volunteers Groups: Mean Testosterone Plasma Level [ Time Frame: Visit 1 (Up to 3 Hours) ]
    Peripherals levels of testosterone will be assessed via assay of plasma collected.


Enrollment: 707
Study Start Date: April 2008
Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Healthy Volunteers - Intranasal Vasopressin (AVP)
The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.
Drug: 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).
Experimental: Healthy Volunteers - Intranasal Oxytocin (OT)
The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.
Drug: 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.
Other Name: Oxytocin: Syntocinon Nasal Spray
Placebo Comparator: Healthy Volunteers - Intranasal Placebo
The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.
Drug: 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.
Experimental: 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.
Drug: 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.
Other Name: Oxytocin: Syntocinon Nasal Spray
Drug: 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).
Drug: 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.
Experimental: 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.
Drug: 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.
Placebo Comparator: Faces Task - Placebo
Healthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning.
Drug: 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.
Experimental: 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.
Drug: 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.
Other Name: Oxytocin: Syntocinon Nasal Spray
Drug: 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.
Placebo Comparator: 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.
Drug: 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.
Experimental: Anxious and Depressed Subjects - OT
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
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.
Other Name: Oxytocin: Syntocinon Nasal Spray
Placebo Comparator: Anxious and Depressed Subjects - Placebo
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
Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.
Experimental: 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.
Drug: Lorazepam
Subjects will take 1.0 mg of lorazepam orally 60 minutes prior to fMRI scan.

Detailed Description:

There are several objective to the study.

Objective 1: In this double-blind, placebo-controlled, pharmaco- fMRI study, men and women will be randomized to treatment with either 24 IU intranasal OT, 20 IU intranasal AVP, or placebo (PL). Approximately 40 minutes later, brain function will be imaged with fMRI as participants play an iterated Prisoner's Dilemma game with same-sex partners. The resulting data will be analyzed to investigate OT and AVP effects on cooperative behavior and the neural response to cooperative social interactions.

In addition to this cross-sectional design, a subset of participants will return on a second day for a within-subject study.

Objective 2: Men and healthy women will be randomized to treatment with either 40 IU intranasal AVP or a saline placebo approximately 30 minutes before their brain function is measured with fMRI as they view same and other-sex faces. All subjects will be scanned a second time several days later with no treatment to evaluate the persistence of AVP effects over time. The resulting data will be analyzed to investigate AVP effects on subjective evaluations and neural responses to viewing same and opposite sex faces.

Objective 3: Healthy men and healthy women will receive either 24IU intranasal OT or PL approximately 40 minutes before their brain function is measured with fMRI as they view animations of geometric shapes depicting either random movement or social interactions such as playing, chasing, fighting. All participants will receive PL on scan 1 and will be randomized to either 24IU intranasal OT or PL on scan 2. The resulting data will be analyzed to investigate OT effects on subjective evaluations and neural responses to the animations.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-30 years of age
  • 21-30 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

Exclusion Criteria:

  • 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)
  • Migraines (can be included as discretion of PI, if episodes are infrequent, nonmedicated, and no active problems at time of study)
  • Claustrophobia (at discretion of PI)

Additional exclusion criteria for Lorazepam arm

  • Acute narrow-angle glaucoma
  • Compromised respiratory function (e.g. sleep apnea and chronic obstructive pulmonary disease)
  • Impaired renal and hepatic function
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01566539


Locations
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30307
Emory University 1462 Clifton Rd
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
National Institute of Mental Health (NIMH)
John Templeton Foundation
Investigators
Principal Investigator: James K Rilling, Ph.D. Emory University
  More Information

Additional Information:
Publications:
Responsible Party: James K. Rilling, PhD, Associate Professor, 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
Last Verified: September 2017

Keywords provided by James K. Rilling, PhD, Emory University:
Social cooperation
Oxytocin
Vasopressin
Prisoner's Dilemma game
Empathy
fMRI

Additional relevant MeSH terms:
Pharmaceutical Solutions
Oxytocin
Lorazepam
Vasopressins
Arginine Vasopressin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents