Clinical trial NCT01722071: Deciphering the Role of Oxytocin in Motivation: an fMRI Study
Official title: Deciphering the Role of Oxytocin in Motivation: an fMRI Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Focus of Study: Neural Correlates of Oxytocin Administration
Keywords: Oxytocin
Functional Magnetic Resonance Imaging
Social
Motivation
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2012-11-06
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment.
timeFrame: Change from Week 1, Day 1 (Scan 1) and Scan 2 (within the first 30 days after scan 1).
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Tiffany M Love, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mickey BJ, Heffernan J, Heisel C, Pecina M, Hsu DT, Zubieta JK, Love TM. Oxytocin modulates hemodynamic responses to monetary incentives in humans. Psychopharmacology (Berl). 2016 Dec;233(23-24):3905-3919. doi: 10.1007/s00213-016-4423-6. Epub 2016 Sep 10.