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Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02742532
Recruitment Status : Completed
First Posted : April 19, 2016
Results First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
United States Naval Medical Center, San Diego
United States Department of Defense
Congressionally Directed Medical Research Programs
Eisenhower Army Medical Center
Information provided by (Responsible Party):
Jennifer Mitchell, University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Stress Disorders, Post-Traumatic Anxiety Disorders Substance Use Disorders Drug: Oxytocin Drug: Placebo Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress
Actual Study Start Date : April 20, 2017
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Oxytocin
Intra-nasal oxytocin (40 IUs; 5 puffs in each nostril)
Drug: Oxytocin
Intranasal oxytocin 40 IU
Other Name: Syntocinon nasal spray

Placebo Comparator: Placebo
Intra-nasal saline placebo (5 puffs in each nostril)
Drug: Placebo
Intranasal saline solution




Primary Outcome Measures :
  1. Change in Craving to Use Alcohol Rating (Visual Analog Scale) [ Time Frame: Change from baseline to post-drug at 20 minutes ]
    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.


Secondary Outcome Measures :
  1. Change in Stress Rating (Visual Analog Scale) [ Time Frame: Change from baseline to post-drug at 20 minutes ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02742532


Locations
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United States, California
Naval Medical Center San Diego
San Diego, California, United States, 92106
Sponsors and Collaborators
Jennifer Mitchell
United States Naval Medical Center, San Diego
United States Department of Defense
Congressionally Directed Medical Research Programs
Eisenhower Army Medical Center
Investigators
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Principal Investigator: Mardi Smith, PhD United States Naval Medical Center, San Diego
  Study Documents (Full-Text)

Documents provided by Jennifer Mitchell, University of California, San Francisco:
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Responsible Party: Jennifer Mitchell, Associate Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02742532    
Other Study ID Numbers: NMCSD Oxytocin
First Posted: April 19, 2016    Key Record Dates
Results First Posted: October 19, 2020
Last Update Posted: October 19, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Alcoholism
Substance-Related Disorders
Anxiety Disorders
Stress Disorders, Post-Traumatic
Pathologic Processes
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs