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 @ 9:57 PM
Ignite Modification Date:
2025-12-24 @ 9:57 PM
NCT ID:
NCT02742532
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02742532
Study Brief:
Protocol Section:
NCT02742532