Deciphering the Role of Oxytocin in Motivation: an fMRI Study

NCT01722071 | Completed Phase 2 Results

• 1 other identifier: UL1RR024986
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Focus of Study: Neural Correlates of Oxytocin Administration

Keywords

Oxytocin; Functional Magnetic Resonance Imaging; Social; Motivation

Outcome Measures

Primary Outcomes (1)

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

  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).

  Change from Week 1, Day 1 (Scan 1) and Scan 2 (within the first 30 days after scan 1).

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Oxytocin

EXPERIMENTAL

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

Drug: Oxytocin

Interventions

Placebo DRUG

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

Placebo

Oxytocin DRUG

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

Also known as: Syntocinon®

Oxytocin

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tiffany Love: lead
• University of Michigan: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 27614896 DERIVED

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Tiffany Love, PhD
• Organization: University of Michigan

tiflove@umich.edu

734-219-3674

Study Officials

• Tiffany M Love, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Investigator

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: November 6, 2012
• Study Start: October 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2015
• Last Updated: January 29, 2016
• Results First Posted: June 29, 2015

Record last verified: 2015-12

Locations

US (1)