- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03016598
Stimulant Oxytocin Study (SOS)
6-week Trial of Oxytocin for Co-occurring Cocaine and Opioid Use Disorders
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Sacramento, California, United States, 95655
- VA Northern California Health Care System, Mather, CA
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San Francisco, California, United States, 94121
- San Francisco VA Medical Center, San Francisco, CA
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Oregon
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Portland, Oregon, United States, 97239
- VA Portland Health Care System, Portland, OR
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- At least 18 years old
- Enrolled as a patient who at the SFVAMC Opioid Treatment Program or the Oakland Behavioral Health Clinic Opioid Treatment Program
- Stable dose of opioid replacement therapy for at least 2 consecutive weeks
- Veteran
- One documented urine toxicology screen positive for stimulants in the past 12 months.
Exclusion Criteria:
- Severe neuropsychological disorder
- Suicidal or homicidal ideation within the past 90 days or a suicide attempt in the past 6 months
- Hemodialysis, unless participant can produce urine samples weekly
- Sensitivity to methylparaben or propylparaben
- Positive urine pregnancy test or women of childbearing age not practicing effective means of non-hormonal birth control
- Chronic nasal obstruction, discharge, or bleeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Oxytocin
Patients in methadone maintenance treatment (MMT) programs are required to come in every day for their methadone.
Additionally they are required to come in weekly for psycho- educational/therapy groups, biweekly random urine screenings, and monthly individual therapy sessions.
The investigators will piggy-back off this existing structure and randomize Veterans with stimulant use disorders and receiving MMT for co-occurring opioid use disorder (OUD) to receive either oxytocin or placebo, to be administered twice daily for six weeks while in the MMT program.
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Each Veteran with a stimulant use disorder, receiving MMT for OUD will receive a oxytocin nasal spray 40 International Units (IU) to be self administered twice daily over 6 weeks while in the MMT program.
The veteran will come in for a total of 7 weekly visits.
At baseline and during the last visit the veteran will complete at Trier Social Stress Test (TSST), and psychophysiological and biomarkers of stress will be collected.
At every weekly visit a urine sample and self-reported drug use will be collected and therapy attendance will be recorded.
Other Names:
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Placebo Comparator: Placebo
Patients in MMT programs are required to come in every day for their methadone.
Additionally they are required to come in weekly for psycho- educational/therapy groups, biweekly random urine screenings, and monthly individual therapy sessions.
The investigators will piggy-back off this existing structure and randomize Veterans with stimulant use disorders and receiving MMT for co-occurring OUD to receive either oxytocin or placebo, to be administered twice daily for six weeks while in the MMT program.
|
Each Veteran with a stimulant use disorder, receiving MMT for OUD will receive a placebo nasal spray 40IU to be self administered twice daily over 6 weeks while in the MMT program.
The veteran will come in for a total of 7 weekly visits.
At baseline and during the last visit the veteran will complete at Trier Social Stress Test (TSST), and psychophysiological and biomarkers of stress will be collected.
At every weekly visit a urine sample and self-reported drug use will be collected and therapy attendance will be recorded.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Stimulant Positive Drug Screen
Time Frame: Baseline, Visits 1-7, up to 7 weeks
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Aim 1: To evaluate the effectiveness of intranasal oxytocin on reducing stimulant use.
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Baseline, Visits 1-7, up to 7 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Working Alliance Inventory (WAI)
Time Frame: Visits 1 and 7, Up to 7 weeks
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Aim 2: To evaluate the effectiveness of intranasal oxytocin on improving psychosocial treatment engagement (social support) as measured by the Working Alliance Inventory, an inventory of therapeutic alliance.
The Working Alliance Inventory is a 36 question inventory.
Each item is scored from 1-7, minimum = 1 and maximum = 7. Minimum total score = 36 to maximum total score = 252.
Higher scores represent higher satisfaction.
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Visits 1 and 7, Up to 7 weeks
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Heart Rate in Response to Trier Social Stress Test (TSST).
Time Frame: Visits 1 and 7, up to 7 weeks
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Aim 3: To evaluate the effectiveness of intranasal oxytocin on reducing stress-related psycho-physiological measures in response to the Trier Social Stress Test (TSST). The Trier Social Stress Test is a series of tasks which predictably induce stress in participants. First, physiological states are measured at baseline. Then participants are told they must prepare a 5 minute speech for a panel of researchers, which they then present. Participants are then asked verbal arithmetic questions. Finally, this is followed by a period of 5 minute rest referred to as the 'cooldown' period. Heart rate was assessed at different time points during the TSST. These time point are as follows: baseline, during speech preparation, during speech presentation, during arithmetic problems, and during the cooldown period. Higher scores indicate higher stress levels. |
Visits 1 and 7, up to 7 weeks
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Respiratory Rate in Response to Trier Social Stress Test (TSST).
Time Frame: Visits 1 and 7, up to 7 weeks
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Aim 3: To evaluate the effectiveness of intranasal oxytocin on reducing stress-related psycho-physiological measures in response to the Trier Social Stress Test (TSST). The Trier Social Stress Test is a series of tasks which predictably induce stress in participants. First, physiological states are measured at baseline. Then participants are told they must prepare a 5 minute speech for a panel of researchers, which they then present. Participants are then asked verbal arithmetic questions. Finally, this is followed by a period of 5 minute rest referred to as the 'cooldown' period. Respiratory rate was assessed at different time points during the TSST. These time point are as follows: baseline, during speech preparation, during speech presentation, during arithmetic problems, and during the cooldown period. Higher scores indicate higher stress levels. |
Visits 1 and 7, up to 7 weeks
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Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST).
Time Frame: Visits 1 and 7, up to 7 weeks
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Aim 3: To evaluate the effectiveness of intranasal oxytocin on reducing stress-related psycho-physiological measures in response to the Trier Social Stress Test (TSST). The Trier Social Stress Test is a series of tasks which predictably induce stress in participants. First, physiological states are measured at baseline. Then participants are told they must prepare a 5 minute speech for a panel of researchers, which they then present. Participants are then asked verbal arithmetic questions. Finally, this is followed by a period of 5 minute rest referred to as the 'cooldown' period. Respiratory sinus arrythmia (RSA) was assessed at different time points during the TSST. These time point are as follows: baseline, during speech preparation, during speech presentation, during arithmetic problems, and during the cooldown period. Higher scores indicate higher stress levels. |
Visits 1 and 7, up to 7 weeks
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Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST).
Time Frame: Visits 1 and 7, up to 7 weeks
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Aim 3: To evaluate the effectiveness of intranasal oxytocin on reducing stress-related psycho-physiological measures in response to the Trier Social Stress Test (TSST). The Trier Social Stress Test is a series of tasks which predictably induce stress in participants. First, physiological states are measured at baseline. Then participants are told they must prepare a 5 minute speech for a panel of researchers, which they then present. Participants are then asked verbal arithmetic questions. Finally, this is followed by a period of 5 minute rest referred to as the 'cooldown' period. The root mean square of successive differences (RMSSD) were assessed at different time points during the TSST. These time point are as follows: baseline, during speech preparation, during speech presentation, during arithmetic problems, and during the cooldown period. Higher scores indicate higher stress levels. Calculated by measuring each successive time difference between heartbeats in ms. |
Visits 1 and 7, up to 7 weeks
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Self-reported Stimulant Craving
Time Frame: Visits 1 and 7, Up to 7 weeks
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Aim 4: To evaluate the effectiveness of intranasal oxytocin on reducing stimulant craving in response the Trier Social Stress Test (TSST). The Cocaine Craving Questionnaire (CCQ) (brief) was modified to include all stimulants and administered. The CCQ is a 10-item questionnaire, with each item ranking on a scale of 1-7. 1 indicates 'Strongly Disagree' and 7 indicates 'Strongly Agree'. Higher scores indicate higher rates of craving. The CCQ was administered at three distinct time points: before the TSST, immediately after the TSST and 20 minutes post-TSST. The Trier Social Stress Test is a series of tasks which predictably induce stress in participants. First, physiological states are measured at baseline. Then participants are told they must prepare a 5 minute speech for a panel of researchers, which they then present. Participants are then asked verbal arithmetic questions. Finally, this is followed by a period of 5 minute rest referred to as the 'cooldown' period. |
Visits 1 and 7, Up to 7 weeks
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Individual and Group Therapy Attendance Rates
Time Frame: Visits 1-7, Up to 7 weeks
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Aim 5: To evaluate the effectiveness of intranasal oxytocin on improving psychosocial treatment engagement (social support) as measured by individual and group therapy attendance rates.
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Visits 1-7, Up to 7 weeks
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Cortisol Levels in Response to Trier Social Stress Test (TSST).
Time Frame: Visits 1 and 7, up to 7 weeks
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Aim 6: To evaluate the effectiveness of intranasal oxytocin on reducing stress biomarkers in response to the TSST.
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Visits 1 and 7, up to 7 weeks
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Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST)
Time Frame: Visits 1 and 7, up to 7 weeks
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Aim 6: To evaluate the effectiveness of intranasal oxytocin on reducing stress biomarkers in response to the TSST.
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Visits 1 and 7, up to 7 weeks
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Self-reported Stress/Anxiety
Time Frame: Visits 1 and 7, Up to 7 weeks
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Aim 7: To evaluate the effectiveness of intranasal oxytocin on reducing self-reported stress/anxiety levels in response to the TSST.
The scale used to measure anxiety was the State-Trait Anxiety Inventory (STAI-6).
This scale consists of 40 questions, all of which are rated on a 4-point likert scale. 1 indicates 'Almost Never' while 4 indicates 'Almost Always'.
The minimum score is 0, indicating no anxiety, and maximum score is 63, indicating severe anxiety.
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Visits 1 and 7, Up to 7 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Christopher Stauffer, MD, San Francisco VA Medical Center, San Francisco, CA
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NURA-014-16S
- 1IK2CX001495-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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