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Completed

NCT Number: NCT01566539

Biological Basis of Individual Variation in Social Cooperation

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.

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Key information

Conditions

Healthy Diabetes Insipidus Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pituitary Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University 1462 Clifton Rd, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Oxytocin: Syntocinon Nasal Spray

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).

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.

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.

Lorazepam

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • John Templeton Foundation
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

The Biological Basis of Individual Variation in Social Cooperation

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Mar 29, 2012
Registry last updated
Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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