Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress

• 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: Jennifer Mitchell
• 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: April 14, 2016
• First Posted Date: April 19, 2016
• Results First Submitted Date: August 19, 2020
• Results First Posted Date: October 19, 2020
• Last Update Posted Date: October 19, 2020
• Actual Study Start Date: April 20, 2017
• Actual Primary Completion Date: July 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: April 14, 2016): Craving to use alcohol [ Time Frame: Prior to and up to 2 hours following intervention ]

Current Secondary Outcome Measures (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 (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: Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Basic Science

Condition

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

Intervention

• Drug: Oxytocin
  Intranasal oxytocin 40 IU
  Other Name: Syntocinon nasal spray
• Drug: Placebo
  Intranasal saline solution

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 1, 2019): 63
• Original Estimated Enrollment (submitted: April 14, 2016): 80
• Actual Study Completion Date: July 1, 2019
• Actual Primary Completion Date: July 1, 2019 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02742532
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Jennifer Mitchell, University of California, San Francisco
• Study Sponsor: Jennifer Mitchell

Collaborators

• United States Naval Medical Center, San Diego
• United States Department of Defense
• Congressionally Directed Medical Research Programs
• Eisenhower Army Medical Center

Investigators

• Principal Investigator: Mardi Smith, PhD; United States Naval Medical Center, San Diego

• PRS Account: University of California, San Francisco
• Verification Date: September 2020