Biological Basis of Individual Variation in Social Cooperation
NCT ID: NCT01566539
Last Updated: 2017-09-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
707 participants
INTERVENTIONAL
2008-04-30
2016-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
BASIC_SCIENCE
TRIPLE
Study Groups
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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 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.
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.
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.
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.
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.
Interventions
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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 adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.
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.
Lorazepam
Subjects will take 1.0 mg of lorazepam orally 60 minutes prior to fMRI scan.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
* Acute narrow-angle glaucoma
* Compromised respiratory function (e.g. sleep apnea and chronic obstructive pulmonary disease)
* Impaired renal and hepatic function
18 Years
30 Years
ALL
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
John Templeton Foundation
OTHER
Emory University
OTHER
Responsible Party
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James K. Rilling, PhD
Associate Professor
Principal Investigators
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James K Rilling, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory University Hospital
Atlanta, Georgia, United States
Emory University 1462 Clifton Rd
Atlanta, Georgia, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Related Links
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Other Identifiers
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MH087721-01A1
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00007905
Identifier Type: -
Identifier Source: org_study_id