Oxytocin and Stress Response in Alcohol Use Disorder
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Intervention: Oxytocin; Placebo
Intervention description: The neuropeptide oxytocin (OT) increases social approach, trust, and reduces anxiety to social stress.; Saline solution.
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 21 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      Individuals with alcohol use disorder (AUD) will complete one functional Magnetic Resonance
      Imaging (fMRI) scanning visit. Prior to the scan, individuals will receive a nasal spray of
      either 24 international units (IU) of oxytocin (OT), or placebo (PBO). During the scan, they
      will perform the Montreal Imaging Stress Task (MIST), a social stress task. Subjective
      craving and anxiety data will be collected.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 21-40.

          2. Subjects must be able to provide informed consent and function at an intellectual
             level sufficient to allow accurate completion of all assessment instruments.

          3. Meets the DSM 5 criteria for current alcohol use disorder.

          4. Reports drinking on average, at least 20 standard alcoholic drinks per week for at
             least the past three months.

          5. Currently not engaged in, and does not want treatment for, alcohol related problems.

          6. Lives within 50 miles of the study site.

          7. Subjects must consent to random assignment.

          8. Able to maintain abstinence for two days (without the aid of detoxification
             medications) as determined by self report and breathalyzer measurements Subjects must
             also have a negative breathalyzer urine drug screen at the study visit.

          9. Subjects must consent to the study visit which includes an outpatient admission to the
             Addiction Sciences Division and completing one functional magnetic resonance imaging
             (fMRI) scanning session.

        Exclusion Criteria:

          1. Currently meets DSM 5 criteria for any other psychoactive substance use disorder.

          2. Is determined

          3. Any psychoactive substance use (except marijuana and nicotine) within the last 30 days
             by self-report and urine drug screen. For marijuana, no use within the last seven days
             by verbal report and negative (or decreasing) urine THC levels.

          4. Meets DSM 5 criteria for current major depression, panic disorder,
             obsessive-compulsive disorder, post traumatic stress syndrome, bipolar affective
             disorder, schizophrenia, dissociate disorders, eating disorders, and any other
             psychotic disorder or organic mental disorder.

          5. Has current suicidal ideation or homicidal ideation.

          6. Has the need for maintenance or acute treatment with any psychoactive medication
             including anti-seizure medications and medications for ADHD.

          7. Is currently taking medication known to affect alcohol intake (e.g., disulfiram,
             naltrexone, acamprosate, topiramate).

          8. Has clinically significant medical problems such as cardiovascular, renal, GI,
             neurological (e.g. seizure disorder) or endocrine problems that would impair
             participation or limit medication ingestion.

          9. Has past history of alcohol related medical illness such as gastrointestinal bleeding,
             pancreatitis, peptic ulcer, hepatic cirrhosis or alcoholic hepatitis.

         10. Has hepatocellular disease indicated by elevations of SGPT (ALT) or SGOT (AST) greater
             than 2.5 times normal at screening.

         11. Females of childbearing potential who are pregnant (by urine HCG), nursing, or who are
             not using a reliable form of birth control.

         12. Has current charges pending for a violent crime (not including DUI related offenses).

         13. Does not have a stable living situation.

         14. Presence of ferrous metal in the body, as evidence by metal screening and self-report.

         15. Severe claustrophobia or morbid obesity that preclude placement in the MRI scanner.

         16. History of head injury with >2 minutes of unconsciousness.