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| Name | Class |
|---|---|
| University of Michigan | OTHER |
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The proposed study will investigate the effects of intranasal oxytocin administration on neural activity associated with social and non-social motivation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Each participant will be studied using fMRI following self-administration of placebo. |
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| Oxytocin | Experimental | Each participant will be studied using fMRI following self-administration of oxytocin. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tiffany M Love, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27614896 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Then Oxytocin | These participants were first studied using fMRI following self-administration of placebo (followed by another scanning session with oxytocin). Placebo: Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session. |
| FG001 | Oxytocin Then Placebo | These participants were first studied using fMRI following self-administration of oxytocin (followed by another scanning session with placebo). Oxytocin: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Subjects who completed Baseline Assessments prior to scanning.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants | Each participant will complete baseline assessments prior to being studied using fMRI |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Mean | Standard Error | BOLD signal change (beta values) | Change from Week 1, Day 1 (Scan 1) and Scan 2 (within the first 30 days after scan 1). |
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Adverse event data was collected on each scanning day and 24 hours later (i.e. assessed at 4 different time points for each participant).
Serious adverse events were collected/assessed, but none were observed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Then Oxytocin | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tiffany Love, PhD | University of Michigan | 734-219-3674 | tiflove@umich.edu |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Oxytocin | Drug | Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session. |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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. |
| OG001 | Oxytocin Then Placebo | Each participant will be studied using fMRI following self-administration of oxytocin. Oxytocin: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session. |
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| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Oxytocin Then Placebo | Each participant will be studied using fMRI following self-administration of oxytocin. Oxytocin: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session. | 0 | 10 | 0 | 10 |
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |