Focus of Study: Neural Correlates of Oxytocin Administration
Conditions
Keywords
Oxytocin, Functional Magnetic Resonance Imaging, Social, Motivation
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.
Interventions
DRUGPlacebo
Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session.
DRUGOxytocin
Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session.
Sponsors
University of Michigan
Tiffany Love
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment. | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants Each participant will complete baseline assessments prior to being studied using fMRI | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 22 years STANDARD_DEVIATION 2 |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
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).
Time frame: Change from Week 1, Day 1 (Scan 1) and Scan 2 (within the first 30 days after scan 1).
Population: Only 8 participants' BOLD data were included in the final group analysis in the Placebo then Oxytocin arm -- 1 participant was excluded from the study prior to scanning, 1 participant was scanned but due to technical issues the BOLD data was not used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Then Oxytocin | Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment. | Oxytocin | 0.6119 BOLD signal change (beta values) | Standard Error 0.204 |
| Placebo Then Oxytocin | Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment. | Placebo | 0.7944 BOLD signal change (beta values) | Standard Error 0.3252 |
| Oxytocin Then Placebo | Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment. | Oxytocin | 0.6688 BOLD signal change (beta values) | Standard Error 0.3642 |
| Oxytocin Then Placebo | Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment. | Placebo | 0.5790 BOLD signal change (beta values) | Standard Error 0.2515 |
Comparison: A two-sided paired t-test was performed to determine whether oxytocin administration was associated with reward-related BOLD signal changes (within the Nucleus Accumbens \[Bilateral\]). For the group of 18 participants, BOLD signal activity was compared between oxytocin and placebo scanning days.p-value: 0.89t-test, 2 sided
Comparison: A two-sided paired t-test was performed to determine whether oxytocin administration was associated with reward-related BOLD signal changes (within the Nucleus Accumbens \[Bilateral\]). For the group of 8 participants, BOLD signal activity was compared between oxytocin and placebo scanning days.p-value: 0.422t-test, 2 sided
Comparison: A two-sided paired t-test was performed to determine whether oxytocin administration was associated with reward-related BOLD signal changes (within the Nucleus Accumbens \[Bilateral\]). For the group of 10 participants, BOLD signal activity was compared between oxytocin and placebo scanning days.p-value: 0.814t-test, 2 sided