The proposed study will investigate the effects of intranasal oxytocin administration on neural activity associated with social and non-social motivation.
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Basic Science
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: September 2013
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.
- Drug: Placebo
- Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session.
- Drug: Oxytocin
- Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session.
Arms, Groups and Cohorts
- Placebo Comparator: Placebo
- Each participant will be studied using fMRI following self-administration of placebo.
- Experimental: Oxytocin
- Each participant will be studied using fMRI following self-administration of oxytocin.
Clinical Trial Outcome Measures
- 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).
Participating in This Clinical Trial
- 20-35 years of age at the time of screening
- 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
- 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
Gender Eligibility: Male
Minimum Age: 20 Years
Maximum Age: 35 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Tiffany Love
- University of Michigan
- Provider of Information About this Clinical Study
- Sponsor-Investigator: Tiffany Love, Research Investigator – University of Michigan
- Overall Official(s)
- Tiffany M Love, PhD, Principal Investigator, University of Michigan
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