Alcohol Use Disorder Clinical Trial
Official title:
Deciphering the Role of Oxytocin in Motivation: an fMRI Study. Part II
Verified date | September 2023 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The proposed study will investigate the effects of intranasal oxytocin administration on neural activity associated with social and non-social motivation.
Status | Active, not recruiting |
Enrollment | 88 |
Est. completion date | June 2024 |
Est. primary completion date | June 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: 1. 18-45 years of age at the time of screening Exclusion Criteria: 2. 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) 3. Psychiatric Illness Criteria: 1. Controls: No current or past history of psychiatric illness, including substance use disorder (except nicotine) 2. AUD: No history of, or current, psychotic disorder, antisocial personality disorder, or bipolar disorder, or concurrent post-traumatic stress disorder. Must meet DSM-5 criteria for current moderate-to-severe AUD, abstinent from alcohol for 2-8 weeks prior to study enrollment, express a desire to achieve abstinence or to greatly reduce alcohol consumption 4. Illicit Drug Use 1. Control: Any reported current (within the last 2 months) use of any category of illicit drugs 2. Patients: Dependence (moderate to severe) to any other substance within the last 2 months other than alcohol or nicotine 5. Any current or past history of any serious medical or neurological illness 6. 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). 7. Abnormal MRI (except if due to technical factors) 8. Female subjects who are pregnant, trying to become pregnant, or nursing 9. Known allergies to oxytocin or to preservatives in the nasal spray 10. Participants reporting use of an intranasal medication in the past two weeks 11. 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. 12. Unable to comply with study procedures or protocols |
Country | Name | City | State |
---|---|---|---|
United States | Huntsman Mental Health Institute - University of Utah HealthCare | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | ||
Primary | 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) | ||
Primary | 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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