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OpenTrials
Completed

NCT Number: NCT01722071

Deciphering the Role of Oxytocin in Motivation: an fMRI Study

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

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Key information

Age range

20 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session.

Oxytocin

Drug

Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session.

Other names: Syntocinon®

Primary outcomes

  1. Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment.

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Tiffany Love

Other

Collaborators

  • University of Michigan

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Nov 6, 2012
Registry last updated
Jan 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.