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Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Placebo
Sponsored by
Jennifer Mitchell
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Naval Medical Center San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oxytocin

Placebo

Arm Description

Intra-nasal oxytocin (40 IUs; 5 puffs in each nostril)

Intra-nasal saline placebo (5 puffs in each nostril)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 14, 2016
Last Updated
September 21, 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
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1. Study Identification

Unique Protocol Identification Number
NCT02742532
Brief Title
Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress
Official Title
Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Stress Disorders, Post-Traumatic, Anxiety Disorders, Substance Use Disorders

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin
Arm Type
Experimental
Arm Description
Intra-nasal oxytocin (40 IUs; 5 puffs in each nostril)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intra-nasal saline placebo (5 puffs in each nostril)
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Syntocinon nasal spray
Intervention Description
Intranasal oxytocin 40 IU
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Intranasal saline solution
Primary Outcome Measure Information:
Title
Change in Craving to Use Alcohol Rating (Visual Analog Scale)
Description
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.
Time Frame
Change from baseline to post-drug at 20 minutes
Secondary Outcome Measure Information:
Title
Change in Stress Rating (Visual Analog Scale)
Description
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.
Time Frame
Change from baseline to post-drug at 20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mardi Smith, PhD
Organizational Affiliation
United States Naval Medical Center, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Medical Center San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress

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