Deciphering the Role of Oxytocin in Motivation: an fMRI Study

Study Overview
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Brief Summary
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The proposed study will investigate the effects of intranasal oxytocin administration on neural activity associated with social and non-social motivation.

Detailed Description
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Oxytocin is a well-known social and reproductive hormone demonstrated to have a variety of prosocial effects in humans including enhancing trust and generosity, improving positive communication, increasing eye gaze, and reducing anxiety. Oxytocin is hypothesized to facilitate social behaviors via its modulation of motivational networks. With this study, we will characterize oxytocin's effects on the neural processing of salient stimuli. We will utilize a noninvasive brain imaging technique, functional magnetic resonance imaging (fMRI), to assess brain activity while participants perform tests designed to engage neural circuits associated with the processing of social and non-social stimuli.

Official Title
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Deciphering the Role of Oxytocin in Motivation: an fMRI Study

Conditions
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Focus of Study: Neural Correlates of Oxytocin Administration

Intervention / Treatment
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* Drug: Placebo
* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male 20-35 years of age at the time of screening Right-handedness Non-smoking No current or past history of neurological or psychiatric illness, including substance abuse or dependence No acute medical illness Written informed consent obtained from subject Exclusion Criteria: Female Left-handedness or ambidextrous Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data Known allergies to oxytocin or to preservatives in the nasal spray Participants who exhibit nasal obstruction or upper-respiratory tract infection at the time of scanning or report the use of intranasally administered medications for up to two weeks prior to screening Participants unable to tolerate the scanning procedures or would be unfit for scanning purposes (e.g. metal implants, claustrophobic, unable to lie still for the duration of the scan) Any current or past history of medical, neurological, or psychiatric illness or family history of psychiatric or neurologic disease in first-degree relatives Neurological illness, abnormal MRI (except if due to technical factors) Acute or uncorrected medical illnesses, including history of hepatic or renal dysfunction. Participants currently taking medications including any treatment, current or past with antipsychotics, mood stabilizers, isoniazid, glucocorticoids, psychostimulants and psychostimulant appetite suppressants, or centrally active antihypertensive drugs (e.g., clonidine, reserpine). Treatment within six months with any of the following: hormone use (testosterone, DHEA), antidepressants, opioid drugs. Treatment within one month with sedative hypnotic medications (benzodiazepines, barbiturates), or over the counter sleeping aids Current or past history of substance abuse or dependence Any reported lifetime use of any category of illicit drugs Positive urine drug screen

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Each participant will be studied using fMRI following self-administration of placebo. | Drug: Placebo<br>* Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session.<br>|
| Experimental: Oxytocin<br>Each participant will be studied using fMRI following self-administration of oxytocin. | Drug: Oxytocin<br>* Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session.<br>* Other names: Syntocinon®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment. | Drug effect will be assessed by ascertaining changes in brain activity between placebo and oxytocin sessions. Imaging data will be analyzed from all subjects in a final analysis. Individual subject analyses will be done on a bimonthly basis. Results represent neural responses to the anticipation of an uncertain reward within the Nucleus Accumbens (Bilateral). These are given as beta values (i.e. parameter estimates). | Change from Week 1, Day 1 (Scan 1) and Scan 2 (within the first 30 days after scan 1). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxytocin, Functional Magnetic Resonance Imaging, Social, Motivation