Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress

Completed · Phase 2 · Has a placebo group

Conditions studied: Alcohol Use Disorder, Stress Disorders, Post-Traumatic, Anxiety Disorders, Substance Use Disorders

In brief

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.

Key facts

Study ID

NCT02742532

Run by

Jennifer Mitchell

People needed

63

Starts

2017-04-20

Expected to finish

2019-07-01

Last updated by the study team

2020-10-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Naval Medical Center San Diego — San Diego, California, United States

Full record on ClinicalTrials.gov

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