Alcohol Use Disorder, Anxiety Disorders, Stress Disorders, Post-Traumatic, Substance Use Disorders
Conditions
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.
Interventions
DRUGOxytocin
Intranasal oxytocin 40 IU
DRUGPlacebo
Intranasal saline solution
Sponsors
United States Naval Medical Center, San Diego
United States Department of Defense
Congressionally Directed Medical Research Programs
Eisenhower Army Medical Center
Jennifer Mitchell
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Craving to Use Alcohol Rating (Visual Analog Scale) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Stress Rating (Visual Analog Scale) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oxytocin Intra-nasal oxytocin (40 IUs; 5 puffs in each nostril)
Oxytocin: Intranasal oxytocin 40 IU | 31 |
| Placebo Intra-nasal saline placebo (5 puffs in each nostril)
Placebo: Intranasal saline solution | 32 |
| Total | 63 |
Baseline characteristics
| Characteristic | Oxytocin | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 32 Participants | 63 Participants |
| Age, Continuous | 27.09 years | 27.38 years | 27.24 years |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 29 Participants | 54 Participants |
| Region of Enrollment United States | 31 participants | 32 participants | 63 participants |
| Self-Reported Alcoholic drinks per week | 51.2 standard drinks/week STANDARD_DEVIATION 39.9 | 43.9 standard drinks/week STANDARD_DEVIATION 45.9 | 47.4 standard drinks/week STANDARD_DEVIATION 42.9 |
| Sex: Female, Male Female | 5 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Male | 26 Participants | 29 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 32 |
| other Total, other adverse events | 0 / 31 | 0 / 32 |
| serious Total, serious adverse events | 0 / 31 | 0 / 32 |
Outcome results
Primary
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.
Time frame: Change from baseline to post-drug at 20 minutes
Population: All subjects who completed this outcome measure were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Change in Craving to Use Alcohol Rating (Visual Analog Scale) | 0.076 score on a scale | Standard Deviation 1.77 |
| Placebo | Change in Craving to Use Alcohol Rating (Visual Analog Scale) | -0.928 score on a scale | Standard Deviation 1.42 |
Secondary
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.
Time frame: Change from baseline to post-drug at 20 minutes
Population: All subjects who completed this outcome measure were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oxytocin | Change in Stress Rating (Visual Analog Scale) | -0.755 score on a scale | Standard Deviation 1.24 |
| Placebo | Change in Stress Rating (Visual Analog Scale) | -1.268 score on a scale | Standard Deviation 1.82 |