The Biological Basis of Individual Variation in Social Cooperation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 707
- 试验地点
- 2
- 主要终点
- Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Men
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Healthy Volunteers - Intranasal Vasopressin (AVP)
The AVP group of healthy volunteers will self-administer vasopressin solution prior to completing the PD task.
干预措施: Intranasal Vasopressin (AVP) (Drug)
Healthy Volunteers - Intranasal Oxytocin (OT)
The OT group of healthy volunteers will self-administer oxytocin solution prior to completing the PD task.
干预措施: Intranasal Oxytocin (OT) 24 IU (Drug)
Healthy Volunteers - Intranasal Placebo
The placebo group of healthy volunteers will self-administer a placebo spray prior to completing the PD task.
干预措施: Intranasal Placebo (Drug)
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.
干预措施: Intranasal Oxytocin (OT) 24 IU (Drug)
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.
干预措施: Intranasal Vasopressin (AVP) (Drug)
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.
干预措施: Intranasal Placebo (Drug)
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.
干预措施: Intranasal Vasopressin (AVP) 40 IU (Drug)
Faces Task - Placebo
Healthy volunteers between the ages of 21-30 years will receive placebo prior to completing the Faces task during fMRI scanning.
干预措施: Intranasal Placebo (Drug)
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.
干预措施: Intranasal Oxytocin (OT) 24 IU (Drug)
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.
干预措施: Intranasal Placebo (Drug)
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.
干预措施: Intranasal Placebo (Drug)
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.
干预措施: Intranasal Oxytocin (OT) 24 IU (Drug)
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.
干预措施: Intranasal Placebo (Drug)
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.
干预措施: Lorazepam (Drug)
结局指标
主要结局
Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Men
时间窗: 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.
Within Subject Group: Mean Percent Signal Change in Left Caudate Nucleus in Men and Women
时间窗: 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.
Healthy Volunteers-OT, Placebo: Mean Percent Signal Change in Right Caudate Nucleus in Women
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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 Female During the Prisoners Dilemma Game(Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 2 Weeks))
- Faces Task Group: Mean Approachability Rating of Faces in Women(Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days))
- 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))
- 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))
- Faces Task Groups: Mean Percent Signal Change in Nucleus Accumbens to Faces in Women(Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days))
- Faces Task Groups: Mean Approachability Rating of Faces in Men(Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days))
- Faces Task Groups: Mean Attractiveness Rating of Faces in Men(Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days))
- Faces Task Groups: Mean Attractiveness Rating of Faces in Women(Visit 1 (30-75 Minutes Post-Intervention), Visit 2 (Up to 7 Days))
- Empathy Task Groups: Mean Percent Signal Change in Early Visual Cortex in Response to Animation in Women(Visit 1 (40-75 Minutes Post-Intervention), Visit 2 (Up to 1 Month))
- Empathy Task Groups: Mean Percent Signal Change in Early Visual Cortex in Response to Animation in Men(Visit 1 (40-75 Minutes Post-Intervention), Visit 2 (Up to 1 Month))
研究者
James K. Rilling, PhD
Associate Professor
Emory University