Biological Basis of Individual Variation in Social Cooperation

Emory University

Status: Completed

Conditions: Healthy

Treatments: Drug: Intranasal Vasopressin (AVP) 40 IU; Drug: Intranasal Placebo; Drug: Lorazepam; Drug: Intranasal Vasopressin (AVP); Drug: Intranasal Oxytocin (OT) 24 IU

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01566539

1R01MH084068-01A1 (U.S. NIH Grant/Contract)

MH087721-01A1 (Other Identifier)

IRB00007905

Details and patient eligibility

About

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.

Full 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.

Enrollment: 707 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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707 participants in 11 patient groups, including a placebo group

Healthy Volunteers - Intranasal Vasopressin (AVP)

Experimental group

Description:

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

Treatment:

Drug: Intranasal Vasopressin (AVP)

Healthy Volunteers - Intranasal Oxytocin (OT)

Experimental group

Description:

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

Treatment:

Drug: Intranasal Oxytocin (OT) 24 IU

Healthy Volunteers - Intranasal Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Intranasal Placebo

Within Subject Group

Experimental group

Description:

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.

Treatment:

Drug: Intranasal Oxytocin (OT) 24 IU

Drug: Intranasal Placebo

Drug: Intranasal Vasopressin (AVP)

Faces Task - Vasopressin (AVP)

Experimental group

Description:

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

Treatment:

Drug: Intranasal Vasopressin (AVP) 40 IU

Faces Task - Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Intranasal Placebo

Empathy Task - Oxytocin (OT)

Experimental group

Description:

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.

Treatment:

Drug: Intranasal Oxytocin (OT) 24 IU

Drug: Intranasal Placebo

Empathy Task - Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Intranasal Placebo

Anxious and Depressed Subjects - OT

Experimental group

Description:

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.

Treatment:

Drug: Intranasal Oxytocin (OT) 24 IU

Anxious and Depressed Subjects - Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Intranasal Placebo

Healthy Volunteers - Lorazepam

Experimental group

Description:

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.

Treatment:

Drug: Lorazepam