Deciphering the Role of Oxytocin in Motivation: an fMRI Study

NCT ID: NCT01722071

Last Updated: 2016-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2015-10-31

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.

Conditions

Focus of Study: Neural Correlates of Oxytocin Administration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Each participant will be studied using fMRI following self-administration of placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Oxytocin

Each participant will be studied using fMRI following self-administration of oxytocin.

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

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

Interventions

Placebo

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

Intervention Type: DRUG

Oxytocin

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

Intervention Type: DRUG

Other Intervention Names

Syntocinon®

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: collaborator

Tiffany Love

OTHER

Sponsor Role: lead

Responsible Party

Tiffany Love

Research Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tiffany M Love, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27614896 (View on PubMed)

Other Identifiers

UL1RR024986

Identifier Type: NIH

Identifier Source: org_study_id

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