Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress
Condition: Alcohol Use Disorder; Stress Disorders, Post-Traumatic; Anxiety Disorders; Substance Use Disorders
MeSH terms: Substance-Related Disorders; Alcoholism; Anxiety Disorders; Stress Disorders, Post-Traumatic
Intervention: Oxytocin; Placebo
Intervention description: Intranasal oxytocin 40 IU; Intranasal saline solution
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether oxytocin will decrease craving to use
      drugs/alcohol and stress reactivity following exposure to laboratory-induced stress among
      Active Duty Service Members with a dual diagnosis of alcohol/substance use disorder (ASUD)
      and post-traumatic anxiety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active Duty Service Members, any service branch; age 18-65 years.

          -  Meets clinician assessment for current PTSD OR anxiety disorder NOS OR scores on DASS
             > 10 on Anxiety or > 19 on Stress.

          -  Meets clinician assessment for alcohol use disorder (AUD) OR scores >8 on AUDIT.

          -  If meet current or lifetime criteria for another substance disorder, must indicate
             that AUD is primary.

          -  Subjects taking psychotropic medications will be required to be maintained on a stable
             dose for at least two weeks before study initiation (unless at physician's discretion
             following psychological consult).

          -  Negative urine drug screen test and BAC =0.

          -  Able to comprehend English.

          -  Able to provide informed consent and function at an intellectual level sufficient to
             allow completion of the assessment instruments.

          -  Must consent to random assignment to oxytocin or placebo.

        Exclusion Criteria:

          -  Positive urine drug screen (except marijuana) or BAC > 0.

          -  Untreated subjects currently symptomatic of psychotic or bipolar affective disorders.

          -  Subjects with current suicidal or homicidal ideation and intent, who would present a
             serious suicide risk.

          -  Subjects on psychotropic drugs that have been initiated during the past 2 weeks
             (unless approved at physician's discretion following psychological consult).

          -  Subjects with a history of a major medical illness (e.g., endocrine, cardiovascular,
             central nervous system disorders, peripheral neuropathy, or pulmonary disease) or
             other acute or unstable medical condition that might interfere with safe conduct of
             the study or accurate interpretation of the results.

          -  Subjects experiencing withdrawal symptoms as reported by Clinician or systolic BP≥160
             mmHg, diastolic BP ≥100 mmHg and resting HR ≥100 bpm.

          -  Subject is considered unsuitable for the study in the opinion of study PI or AIs for
             any other reason.