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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, the investigators will characterize oxytocin's effects on the neural processing of salient stimuli. The investigators 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.
Ongoing clinical trials are examining the use of intranasal oxytocin for the treatment of multiple psychiatric disorders including substance dependence, depression, and schizophrenia; disorders which reward system dysfunction appears to play a significant role. As such, it is important that we obtain a better understanding of the neurobiological effects this drug may have on reward circuitry functioning. To this end, in this study, we will examine healthy control participants and participants diagnosed with Alcohol Use Disorder (AUD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Each participant will be studied using fMRI following self-administration of placebo. |
|
| Oxytocin | Experimental | Each participant will be studied using fMRI following self-administration of oxytocin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo intranasal administration, 3 puffs per nostril, delivered prior to scanning session. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment: Control group | Change from Week 1, Day 1, Scan 1 and Scan 2 (approximately 1-4 weeks after Scan 1) | |
| Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment: AUD Group | Change from Week 1, Day 1, Scan 1 and Scan 2 (approximately 1-4 weeks after Scan 1) | |
| Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment. AUD vs Controls | Change from Week 1, Day 1, Scan 1 and Scan 2 (approximately 1-4 weeks after Scan 1) |
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Inclusion Criteria:
18-45 years of age at the time of screening
Exclusion Criteria:
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)
Psychiatric Illness Criteria:
Illicit Drug Use
Any current or past history of any serious medical or neurological illness
Acute or uncorrected medical illnesses, including history of hepatic or renal dysfunction, hyponatremia, traumatic brain injury, atrophic rhinitis, recurrent nose bleeds, and cranial-surgical procedures (hypophysectomy).
Abnormal MRI (except if due to technical factors)
Female subjects who are pregnant, trying to become pregnant, or nursing
Known allergies to oxytocin or to preservatives in the nasal spray
Participants reporting use of an intranasal medication in the past two weeks
Participants taking medications including any current treatment with antipsychotics, antidepressants, mood stabilizers, psychostimulants and psychostimulant appetite suppressants, or past treatment with isoniazid, glucocorticoids, centrally active antihypertensive drugs (e.g., clonidine, reserpine), or sedative hypnotic medications (e.g. benzodiazepines, barbiturates, within 1 week prior to study enrollment). Treatment within six months with any of the following: hormone use (i.e. testosterone, DHEA), opioid drugs.
Unable to comply with study procedures or protocols
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| Name | Affiliation | Role |
|---|---|---|
| Tiffany Love, PhD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Mental Health Institute - University of Utah HealthCare | Salt Lake City | Utah | 84108 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 12, 2024 | |
| Reset | Jun 6, 2024 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 6, 2019 | Jan 5, 2021 | Prot_005.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 14, 2020 | Jan 5, 2021 | ICF_004.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 12, 2024 | Jun 6, 2024 |
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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 prior to scanning session. |
|
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |