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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

Tracking Information
First Submitted Date  ICMJE April 14, 2016
First Posted Date  ICMJE April 19, 2016
Results First Submitted Date  ICMJE August 19, 2020
Results First Posted Date  ICMJE October 19, 2020
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE April 20, 2017
Actual Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2016)
Craving to use alcohol [ Time Frame: Prior to and up to 2 hours following intervention ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2020)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2016)
Stress reactivity [ Time Frame: Prior to and up to 2 hours following intervention ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress
Official Title  ICMJE Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Alcohol Use Disorder
  • Stress Disorders, Post-Traumatic
  • Anxiety Disorders
  • Substance Use Disorders
Intervention  ICMJE
  • Drug: Oxytocin
    Intranasal oxytocin 40 IU
    Other Name: Syntocinon nasal spray
  • Drug: Placebo
    Intranasal saline solution
Study Arms  ICMJE
  • Experimental: Oxytocin
    Intra-nasal oxytocin (40 IUs; 5 puffs in each nostril)
    Intervention: Drug: Oxytocin
  • Placebo Comparator: Placebo
    Intra-nasal saline placebo (5 puffs in each nostril)
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2019)
63
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2016)
80
Actual Study Completion Date  ICMJE July 1, 2019
Actual Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02742532
Other Study ID Numbers  ICMJE NMCSD Oxytocin
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jennifer Mitchell, University of California, San Francisco
Study Sponsor  ICMJE Jennifer Mitchell
Collaborators  ICMJE
  • United States Naval Medical Center, San Diego
  • United States Department of Defense
  • Congressionally Directed Medical Research Programs
  • Eisenhower Army Medical Center
Investigators  ICMJE
Principal Investigator: Mardi Smith, PhD United States Naval Medical Center, San Diego
PRS Account University of California, San Francisco
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP