Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress
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| ClinicalTrials.gov Identifier: NCT02742532 |
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Recruitment Status :
Completed
First Posted : April 19, 2016
Results First Posted : October 19, 2020
Last Update Posted : October 19, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alcohol Use Disorder Stress Disorders, Post-Traumatic Anxiety Disorders Substance Use Disorders | Drug: Oxytocin Drug: Placebo | Phase 2 |
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 (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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Oxytocin
Intra-nasal oxytocin (40 IUs; 5 puffs in each nostril)
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Drug: Oxytocin
Intranasal oxytocin 40 IU
Other Name: Syntocinon nasal spray |
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Placebo Comparator: Placebo
Intra-nasal saline placebo (5 puffs in each nostril)
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Drug: Placebo
Intranasal saline solution |
- 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.
- 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.
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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 |
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.
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
| United States, California | |
| Naval Medical Center San Diego | |
| San Diego, California, United States, 92106 | |
| Principal Investigator: | Mardi Smith, PhD | United States Naval Medical Center, San Diego |
Documents provided by Jennifer Mitchell, University of California, San Francisco:
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 |