Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress

Anxiety Disorders Clinical Trial

Official title:

Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02742532
• Other study ID #: NMCSD Oxytocin
• Status: Completed
• Phase: Phase 2
• Start date: April 20, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: September 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The purpose of this study is to determine whether intra-nasally administered oxytocin will decrease craving to use alcohol and stress reactivity following exposure to laboratory-induced stress among Active Duty Service Members (AD SMs) with a dual diagnosis of alcohol/substance use disorder (ASUD) and post-traumatic anxiety (i.e., PTSD or anxiety disorder NOS). This is a 2-arm placebo controlled study. Subjects will complete a battery of self-report questionnaires and behavioral interviews. Baseline assessments of subjective (craving, stress), physiologic (HR, BP), and neuroendocrine measures (salivary cortisol) will be collected. These same assessments will be repeatedly collected throughout the testing portion of the study. Subjects will receive acute administration of intra-nasal oxytocin or placebo and will then be exposed to a laboratory-induced social stressor. They will be asked to give a short speech and perform arithmetic in front of a panel of judges. Following the task, additional post-task assessments of the subjective, physiological, and neuroendocrine measures will be completed over the next hour.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Anxiety Disorders
• Disease
• Stress Disorders, Post-Traumatic
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Drug:
• Oxytocin
Intranasal oxytocin 40 IU
• Placebo
Intranasal saline solution

Locations

Country	Name	City	State
United States	Naval Medical Center San Diego	San Diego	California

Sponsors (5)

Lead Sponsor	Collaborator
Jennifer Mitchell	Congressionally Directed Medical Research Programs, Eisenhower Army Medical Center, United States Department of Defense, United States Naval Medical Center, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Craving to Use Alcohol Rating (Visual Analog Scale)	The Visual Analog Scale (VAS) is a horizontal line of fixed 100 mm length. The ends are defined as the extreme limits of the parameter from the left (least) to the right (most). Subjects mark the point on the line that represents their perception of the parameter. The score is determined by measuring in millimeters from the left end of the line to the point that the patient marks. The score range is 0-100, with higher scores indicating higher cravings.	Change from baseline to post-drug at 20 minutes
Secondary	Change in Stress Rating (Visual Analog Scale)	The Visual Analog Scale (VAS) is a horizontal line of fixed 100 mm length. The ends are defined as the extreme limits of the parameter from the left (least) to the right (most). Subjects mark the point on the line that represents their perception of the parameter. The score is determined by measuring in millimeters from the left end of the line to the point that the patient marks. The score range is 0-100, with higher scores indicating higher stress.	Change from baseline to post-drug at 20 minutes