Stimulant Use & Co-occuring Opioid Use Disorders Clinical Trial
— SOSOfficial title:
6-week Trial of Oxytocin for Co-occurring Cocaine and Opioid Use Disorders
Verified date | June 2021 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will investigate the effects of intranasal administration of oxytocin, a social neuropeptide, on reducing stimulant use, enhancing therapeutic engagement, and susceptibility to stress-induced relapse in Veterans with stimulant use disorders and enrolled in opioid replacement therapy (ORT) program for co-occurring opioid use disorder (OUD).
Status | Completed |
Enrollment | 42 |
Est. completion date | February 14, 2020 |
Est. primary completion date | February 14, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. At least 18 years old 2. Enrolled as a patient who at the SFVAMC Opioid Treatment Program or the Oakland Behavioral Health Clinic Opioid Treatment Program 3. Stable dose of opioid replacement therapy for at least 2 consecutive weeks 4. Veteran 5. One documented urine toxicology screen positive for stimulants in the past 12 months. Exclusion Criteria: 1. Severe neuropsychological disorder 2. Suicidal or homicidal ideation within the past 90 days or a suicide attempt in the past 6 months 3. Hemodialysis, unless participant can produce urine samples weekly 4. Sensitivity to methylparaben or propylparaben 5. Positive urine pregnancy test or women of childbearing age not practicing effective means of non-hormonal birth control 6. Chronic nasal obstruction, discharge, or bleeding |
Country | Name | City | State |
---|---|---|---|
United States | VA Portland Health Care System, Portland, OR | Portland | Oregon |
United States | VA Northern California Health Care System, Mather, CA | Sacramento | California |
United States | San Francisco VA Medical Center, San Francisco, CA | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Stauffer CS, Woolley JD. Can we bottle psychosocial treatments for addiction? The role of oxytocin. J Clin Psychiatry. 2014 Sep;75(9):1028-9. doi: 10.4088/JCP.14ac09437. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Stimulant Positive Drug Screen | Aim 1: To evaluate the effectiveness of intranasal oxytocin on reducing stimulant use. | Baseline, Visits 1-7, up to 7 weeks | |
Secondary | Working Alliance Inventory (WAI) | 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. | Visits 1 and 7, Up to 7 weeks | |
Secondary | Heart Rate in Response to Trier Social Stress Test (TSST). | 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 | |
Secondary | Respiratory Rate in Response to Trier Social Stress Test (TSST). | 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 | |
Secondary | Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST). | 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 | |
Secondary | Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST). | 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 | |
Secondary | Self-reported Stimulant Craving | 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 | |
Secondary | Individual and Group Therapy Attendance Rates | 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. | Visits 1-7, Up to 7 weeks | |
Secondary | Cortisol Levels in Response to Trier Social Stress Test (TSST). | Aim 6: To evaluate the effectiveness of intranasal oxytocin on reducing stress biomarkers in response to the TSST. | Visits 1 and 7, up to 7 weeks | |
Secondary | Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST) | Aim 6: To evaluate the effectiveness of intranasal oxytocin on reducing stress biomarkers in response to the TSST. | Visits 1 and 7, up to 7 weeks | |
Secondary | Self-reported Stress/Anxiety | 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. | Visits 1 and 7, Up to 7 weeks |