Deciphering the Role of Oxytocin in Motivation: an fMRI Study

Phase 2

Completed

Conditions: Focus of Study: Neural Correlates of Oxytocin Administration

Interventions: Drug: Placebo
Drug: Oxytocin

Registration Number: NCT01722071

Lead Sponsor: Tiffany Love

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

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 20

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Each participant will be studied using fMRI following self-administration of placebo.
Oxytocin	Oxytocin	Each participant will be studied using fMRI following self-administration of oxytocin.

Primary Outcome Measures

Name	Time	Method
Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment.	Change from Week 1, Day 1 (Scan 1) and Scan 2 (within the first 30 days after scan 1).	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).

Secondary Outcome Measures