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Deciphering the Role of Oxytocin in Motivation: an fMRI Study

T

Tiffany Love

Status and phase

Completed
Phase 2

Conditions

Focus of Study: Neural Correlates of Oxytocin Administration

Treatments

Drug: Oxytocin
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01722071
UL1RR024986 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment

20 patients

Sex

Male

Ages

20 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

20 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Each participant will be studied using fMRI following self-administration of placebo.
Treatment:
Drug: Placebo
Oxytocin
Experimental group
Description:
Each participant will be studied using fMRI following self-administration of oxytocin.
Treatment:
Drug: Oxytocin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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