Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-24 @ 1:33 PM
NCT ID:
NCT02652195
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02652195
Study Brief:
Protocol Section:
NCT02652195