Clinical trial: Deciphering the Role of Oxytocin in Motivation: an fMRI Study. Part II (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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years.

Patient description (patient's own words): I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL.

Does the patient match the trial criteria? Contradiction