Overview

This trial is active, not recruiting.

Condition focus of study: neural correlates of oxytocin administration
Treatments placebo, oxytocin
Phase phase 2
Sponsor Tiffany Love
Collaborator University of Michigan
Start date October 2012
End date October 2013
Trial size 20 participants
Trial identifier NCT01722071, UL1RR024986

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose basic science
Arm
(Placebo Comparator)
Each participant will be studied using fMRI following self-administration of placebo.
placebo
Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session.
(Experimental)
Each participant will be studied using fMRI following self-administration of oxytocin.
oxytocin Syntocinon®
Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session.

Primary Outcomes

Measure
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).

Secondary Outcomes

Measure
Salivary Oxytocin Levels
time frame: Collected at Week 1, Day 1 (Scan 1) and Scan 2 (within the first 30 days after scan 1).
Behavioral Data
time frame: Change from Week 1, Day 1 (Scan 1) and Scan 2 (within the first 30 days after scan 1).
Hemodynamic Response Function
time frame: Change from Week 1, Day 1 (Scan 1) and Scan 2 (within the first 30 days after scan 1).
Trait Measures
time frame: Baseline

Eligibility Criteria

Male participants from 20 years up to 35 years old.

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

Additional Information

Official title Deciphering the Role of Oxytocin in Motivation: an fMRI Study
Principal investigator Tiffany M Love, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by University of Michigan.