Stimulant Use & Co-occuring Opioid Use Disorders
Conditions
Keywords
oxytocin, substance-related disorders, Opioid Replacement Therapy, Psychophysiology, Stress Biomarkers
Brief summary
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).
Detailed description
High rates of substance use disorders (SUDs) in Veterans compared to the general population are heavily influenced by psychosocial factors - such as difficulty reintegrating into civilian life due to avoidance of vital support systems - leading to disproportionately elevated unmet addiction treatment needs. Although the gold standard for treatment for most SUDs involves pharmacological interventions, there are currently no effective pharmacological interventions approved by the Federal Drug Administration for stimulant users, who have the most difficulty adhering to treatment programs and the most susceptibility to stress-induced relapse of any SUD. Administering oxytocin, a mammalian neuropeptide, intranasally to healthy controls facilitates the stress-buffering properties of social support. Oxytocin may also have an independent role in mitigating the symptoms of SUDs. For example, in animal models of addiction, oxytocin administration directly reduces tolerance, withdrawal effects, self-administration, and stress-induced reinstatement of drug seeking for a range of addictive substances. A more integrated understanding of oxytocin's distinct effects on the behavior and psychology of 1) addiction, 2) sociality, and 3) stress reactivity could be the key to defining oxytocin's role in SUD treatment. This study proposes to translate promising preclinical and early proof-of-concept clinical results related to the anti-addiction, pro-social, and stress-tempering properties of oxytocin administration in Veterans with moderate-severe stimulant use disorders enrolled in a opioid replacement therapy (ORT) program for co-occurring opioid use disorder (OUD) at the San Francisco VA Medical Center (SFVAMC). The investigators' primary outcome is Aim 1) reduction in stimulant use, as measured by stimulant positive urine drug screen. Secondarily, the investigators will focus on Aim 2) improving psychosocial treatment engagement (social support) and Aim 3) mitigating social stress-related relapse, targeting two important barriers to stimulant use disorder recovery likely to respond to oxytocin administration.
Interventions
DRUGIntranasal oxytocin
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.
DRUGIntranasal placebo
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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Stimulant Positive Drug Screen | Baseline, Visits 1-7, up to 7 weeks | Aim 1: To evaluate the effectiveness of intranasal oxytocin on reducing stimulant use. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Rate in Response to Trier Social Stress Test (TSST). | Visits 1 and 7, up to 7 weeks | 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. |
| Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST). | Visits 1 and 7, up to 7 weeks | 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. |
| Working Alliance Inventory (WAI) | Visits 1 and 7, Up to 7 weeks | 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. |
| Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST). | Visits 1 and 7, up to 7 weeks | 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. |
| Self-reported Stimulant Craving | Visits 1 and 7, Up to 7 weeks | 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. |
| Individual and Group Therapy Attendance Rates | Visits 1-7, Up to 7 weeks | 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. |
| Cortisol Levels in Response to Trier Social Stress Test (TSST). | Visits 1 and 7, up to 7 weeks | Aim 6: To evaluate the effectiveness of intranasal oxytocin on reducing stress biomarkers in response to the TSST. |
| Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST) | Visits 1 and 7, up to 7 weeks | Aim 6: To evaluate the effectiveness of intranasal oxytocin on reducing stress biomarkers in response to the TSST. |
| Heart Rate in Response to Trier Social Stress Test (TSST). | Visits 1 and 7, up to 7 weeks | 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. |
| Self-reported Stress/Anxiety | Visits 1 and 7, Up to 7 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
84 individuals assessed for eligibility, of which 38 were excluded. 28 of the 38 excluded were ineligible - 6 were lost to follow up and 4 were uninterested. The remaining 46 participants completed baseline assessment, of which 4 were excluded - 2 being ineligible, 1 being lost to follow up and the final being uninterested. Left remaining were 42 enrolled participants.
Pre-assignment details
42 individuals were enrolled, 2 of which were excluded due to being lost to follow up before being assigned to an arm.
Participants by arm
| Arm | Count |
|---|---|
| Oxytocin Oxytocin, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course. | 18 |
| Placebo Placebo, to be administered intranasally twice daily for six weeks. TSST will be conducted prior to study drug administration and after the 6-week course. | 22 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
Baseline characteristics
| Characteristic | Placebo | Total | Oxytocin |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 8 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 32 Participants | 18 Participants |
| Age, Continuous | 63.13636 years STANDARD_DEVIATION 7.265676 | 59 years STANDARD_DEVIATION 10.30061 | 53.94444 years STANDARD_DEVIATION 11.35767 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 23 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 12 Participants | 8 Participants |
| Region of Enrollment United States | 22 Participants | 40 Participants | 18 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 22 Participants | 40 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 22 |
| other Total, other adverse events | 1 / 18 | 1 / 22 |
| serious Total, serious adverse events | 0 / 18 | 0 / 22 |
Outcome results
Primary
Number of Participants With Stimulant Positive Drug Screen
Aim 1: To evaluate the effectiveness of intranasal oxytocin on reducing stimulant use.
Time frame: Baseline, Visits 1-7, up to 7 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oxytocin | Number of Participants With Stimulant Positive Drug Screen | Stimulant Positive: Baseline | 9 Participants |
| Oxytocin | Number of Participants With Stimulant Positive Drug Screen | Stimulant Positive: Week 4 | 8 Participants |
| Oxytocin | Number of Participants With Stimulant Positive Drug Screen | Stimulant Postive: Week 2 | 10 Participants |
| Oxytocin | Number of Participants With Stimulant Positive Drug Screen | Stimulant Positive: Week 5 | 9 Participants |
| Oxytocin | Number of Participants With Stimulant Positive Drug Screen | Stimulant Positive: Week 1 | 9 Participants |
| Oxytocin | Number of Participants With Stimulant Positive Drug Screen | Stimulant Positive: Week 6 | 9 Participants |
| Oxytocin | Number of Participants With Stimulant Positive Drug Screen | Stimulant Positive: Week 3 | 8 Participants |
| Oxytocin | Number of Participants With Stimulant Positive Drug Screen | Stimulant Positive: Week 7 | 9 Participants |
| Placebo | Number of Participants With Stimulant Positive Drug Screen | Stimulant Positive: Week 7 | 11 Participants |
| Placebo | Number of Participants With Stimulant Positive Drug Screen | Stimulant Positive: Baseline | 12 Participants |
| Placebo | Number of Participants With Stimulant Positive Drug Screen | Stimulant Positive: Week 1 | 10 Participants |
| Placebo | Number of Participants With Stimulant Positive Drug Screen | Stimulant Postive: Week 2 | 11 Participants |
| Placebo | Number of Participants With Stimulant Positive Drug Screen | Stimulant Positive: Week 3 | 11 Participants |
| Placebo | Number of Participants With Stimulant Positive Drug Screen | Stimulant Positive: Week 4 | 12 Participants |
| Placebo | Number of Participants With Stimulant Positive Drug Screen | Stimulant Positive: Week 5 | 12 Participants |
| Placebo | Number of Participants With Stimulant Positive Drug Screen | Stimulant Positive: Week 6 | 11 Participants |
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.
Time frame: Visits 1 and 7, up to 7 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxytocin | Cortisol Levels in Response to Trier Social Stress Test (TSST). | Initial Cortisol Levels (ug/dL) Week 1 | 0.331 (ug/dL) | Standard Deviation 0.263 |
| Oxytocin | Cortisol Levels in Response to Trier Social Stress Test (TSST). | Pre-Trier Cortisol Levels (ug/dL) Week 1 | 0.283 (ug/dL) | Standard Deviation 0.213 |
| Oxytocin | Cortisol Levels in Response to Trier Social Stress Test (TSST). | Immediately Post-Trier Cortisol Levels (ug/dL) Week 1 | 0.286 (ug/dL) | Standard Deviation 0.221 |
| Oxytocin | Cortisol Levels in Response to Trier Social Stress Test (TSST). | 20Minutes Post-Trier Cortisol Levels (ug/dL) Week 1 | 0.29 (ug/dL) | Standard Deviation 0.184 |
| Oxytocin | Cortisol Levels in Response to Trier Social Stress Test (TSST). | Initial Cortisol Levels (ug/dL) Week 7 | 0.206 (ug/dL) | Standard Deviation 0.155 |
| Oxytocin | Cortisol Levels in Response to Trier Social Stress Test (TSST). | Pre-Trier Cortisol Levels (ug/dL) Week 7 | 0.156 (ug/dL) | Standard Deviation 0.093 |
| Oxytocin | Cortisol Levels in Response to Trier Social Stress Test (TSST). | Immediately Post-Trier Cortisol Levels (ug/dL) Week 7 | 0.167 (ug/dL) | Standard Deviation 0.112 |
| Oxytocin | Cortisol Levels in Response to Trier Social Stress Test (TSST). | 20 Minutes Post-Trier Cortisol Levels (ug/dL) Week 7 | 0.175 (ug/dL) | Standard Deviation 0.13 |
| Placebo | Cortisol Levels in Response to Trier Social Stress Test (TSST). | 20 Minutes Post-Trier Cortisol Levels (ug/dL) Week 7 | 0.168 (ug/dL) | Standard Deviation 0.073 |
| Placebo | Cortisol Levels in Response to Trier Social Stress Test (TSST). | Initial Cortisol Levels (ug/dL) Week 1 | 0.319 (ug/dL) | Standard Deviation 0.335 |
| Placebo | Cortisol Levels in Response to Trier Social Stress Test (TSST). | Initial Cortisol Levels (ug/dL) Week 7 | 0.259 (ug/dL) | Standard Deviation 0.154 |
| Placebo | Cortisol Levels in Response to Trier Social Stress Test (TSST). | Pre-Trier Cortisol Levels (ug/dL) Week 1 | 0.193 (ug/dL) | Standard Deviation 0.163 |
| Placebo | Cortisol Levels in Response to Trier Social Stress Test (TSST). | Immediately Post-Trier Cortisol Levels (ug/dL) Week 7 | 0.184 (ug/dL) | Standard Deviation 0.09 |
| Placebo | Cortisol Levels in Response to Trier Social Stress Test (TSST). | Immediately Post-Trier Cortisol Levels (ug/dL) Week 1 | 0.242 (ug/dL) | Standard Deviation 0.286 |
| Placebo | Cortisol Levels in Response to Trier Social Stress Test (TSST). | Pre-Trier Cortisol Levels (ug/dL) Week 7 | 0.197 (ug/dL) | Standard Deviation 0.115 |
| Placebo | Cortisol Levels in Response to Trier Social Stress Test (TSST). | 20Minutes Post-Trier Cortisol Levels (ug/dL) Week 1 | 0.211 (ug/dL) | Standard Deviation 0.245 |
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.
Time frame: Visits 1 and 7, up to 7 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxytocin | Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST) | Initial DHEA Levels (pg/mL) Week 1 | 86.230 (pg/mL) | Standard Deviation 52.999 |
| Oxytocin | Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST) | Initial DHEA Levels(pg/mL) Week 7 | 87.674 (pg/mL) | Standard Deviation 78.363 |
| Oxytocin | Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST) | Immediately Post-Trier DHEA Levels (pg/mL) Week 1 | 100.468 (pg/mL) | Standard Deviation 76.83 |
| Oxytocin | Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST) | Pre-Trier DHEA Levels (pg/mL) Week 7 | 75.221 (pg/mL) | Standard Deviation 80.167 |
| Oxytocin | Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST) | Pre-Trier DHEA Levels (pg/mL) Week 1 | 90.313 (pg/mL) | Standard Deviation 80.944 |
| Oxytocin | Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST) | Immediately Post-Trier DHEA Levels (pg/mL) Week 7 | 84.230 (pg/mL) | Standard Deviation 72.875 |
| Oxytocin | Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST) | 20 Minutes Post-Trier DHEA Levels (pg/mL) Week 1 | 81.742 (pg/mL) | Standard Deviation 68.051 |
| Oxytocin | Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST) | 20 Minutes Post-Trier DHEA Levels (pg/mL) Week 7 | 82.009 (pg/mL) | Standard Deviation 86.669 |
| Placebo | Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST) | 20 Minutes Post-Trier DHEA Levels (pg/mL) Week 1 | 54.816 (pg/mL) | Standard Deviation 52.98 |
| Placebo | Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST) | Initial DHEA Levels (pg/mL) Week 1 | 62.695 (pg/mL) | Standard Deviation 67.462 |
| Placebo | Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST) | Pre-Trier DHEA Levels (pg/mL) Week 1 | 52.32 (pg/mL) | Standard Deviation 55.91 |
| Placebo | Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST) | Immediately Post-Trier DHEA Levels (pg/mL) Week 1 | 63.471 (pg/mL) | Standard Deviation 57.251 |
| Placebo | Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST) | 20 Minutes Post-Trier DHEA Levels (pg/mL) Week 7 | 66.736 (pg/mL) | Standard Deviation 103.362 |
| Placebo | Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST) | Initial DHEA Levels(pg/mL) Week 7 | 61.581 (pg/mL) | Standard Deviation 77.382 |
| Placebo | Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST) | Pre-Trier DHEA Levels (pg/mL) Week 7 | 54.324 (pg/mL) | Standard Deviation 57.183 |
| Placebo | Dehydroepiandrosterone (DHEA) Levels in Response to Trier Social Stress Test (TSST) | Immediately Post-Trier DHEA Levels (pg/mL) Week 7 | 69.291 (pg/mL) | Standard Deviation 108.134 |
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.
Time frame: Visits 1 and 7, up to 7 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxytocin | Heart Rate in Response to Trier Social Stress Test (TSST). | Heart Rate Baseline: Week 7 | 76.116 Beats/minute | Standard Deviation 8.7493 |
| Oxytocin | Heart Rate in Response to Trier Social Stress Test (TSST). | Heart Rate Baseline: Week 1 | 77.252 Beats/minute | Standard Deviation 8.3482 |
| Oxytocin | Heart Rate in Response to Trier Social Stress Test (TSST). | Heart Rate During Speech Prep: Week 7 | 74.9320 Beats/minute | Standard Deviation 8.4512 |
| Oxytocin | Heart Rate in Response to Trier Social Stress Test (TSST). | Heart Rate During Arithmetic: Week 1 | 85.1227 Beats/minute | Standard Deviation 10.65619 |
| Oxytocin | Heart Rate in Response to Trier Social Stress Test (TSST). | Heart Rate During Speech: Week 7 | 81.8189 Beats/minute | Standard Deviation 8.1597 |
| Oxytocin | Heart Rate in Response to Trier Social Stress Test (TSST). | Heart Rate During Speech Prep: Week 1 | 77.5306 Beats/minute | Standard Deviation 11.1108 |
| Oxytocin | Heart Rate in Response to Trier Social Stress Test (TSST). | Heart Rate During Arithmetic: Week 7 | 82.6265 Beats/minute | Standard Deviation 8.4639 |
| Oxytocin | Heart Rate in Response to Trier Social Stress Test (TSST). | Heart Rate Cooldown: Week 1 | 72.0023 Beats/minute | Standard Deviation 18.7152 |
| Oxytocin | Heart Rate in Response to Trier Social Stress Test (TSST). | Heart Rate Cooldown: Week 7 | 74.9591 Beats/minute | Standard Deviation 9.8852 |
| Oxytocin | Heart Rate in Response to Trier Social Stress Test (TSST). | Heart Rate During Speech: Week 1 | 85.3146 Beats/minute | Standard Deviation 12.1203 |
| Placebo | Heart Rate in Response to Trier Social Stress Test (TSST). | Heart Rate Cooldown: Week 7 | 68.8543 Beats/minute | Standard Deviation 11.8623 |
| Placebo | Heart Rate in Response to Trier Social Stress Test (TSST). | Heart Rate Baseline: Week 1 | 68.1912 Beats/minute | Standard Deviation 13.9445 |
| Placebo | Heart Rate in Response to Trier Social Stress Test (TSST). | Heart Rate During Speech: Week 1 | 79.4769 Beats/minute | Standard Deviation 15.1165 |
| Placebo | Heart Rate in Response to Trier Social Stress Test (TSST). | Heart Rate During Arithmetic: Week 1 | 77.8194 Beats/minute | Standard Deviation 15.6546 |
| Placebo | Heart Rate in Response to Trier Social Stress Test (TSST). | Heart Rate Cooldown: Week 1 | 68.8551 Beats/minute | Standard Deviation 12.1091 |
| Placebo | Heart Rate in Response to Trier Social Stress Test (TSST). | Heart Rate Baseline: Week 7 | 72.6821 Beats/minute | Standard Deviation 11.955 |
| Placebo | Heart Rate in Response to Trier Social Stress Test (TSST). | Heart Rate During Speech Prep: Week 7 | 69.9714 Beats/minute | Standard Deviation 12.1507 |
| Placebo | Heart Rate in Response to Trier Social Stress Test (TSST). | Heart Rate During Speech: Week 7 | 79.2512 Beats/minute | Standard Deviation 14.2214 |
| Placebo | Heart Rate in Response to Trier Social Stress Test (TSST). | Heart Rate During Arithmetic: Week 7 | 82.8517 Beats/minute | Standard Deviation 18.0291 |
| Placebo | Heart Rate in Response to Trier Social Stress Test (TSST). | Heart Rate During Speech Prep: Week 1 | 69.8634 Beats/minute | Standard Deviation 13.2503 |
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.
Time frame: Visits 1-7, Up to 7 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxytocin | Individual and Group Therapy Attendance Rates | Attendance Proportion: Week 2 | 0.9333 proportion of OTP visits attended | Standard Deviation 0.1183 |
| Oxytocin | Individual and Group Therapy Attendance Rates | Attendance Proportion: Week 4 | 0.9260 proportion of OTP visits attended | Standard Deviation 0.1828 |
| Oxytocin | Individual and Group Therapy Attendance Rates | Attendance Proportion: Week 1 | 0.9352 proportion of OTP visits attended | Standard Deviation 0.1416 |
| Oxytocin | Individual and Group Therapy Attendance Rates | Attendance Proportion: Week 5 | 0.8704 proportion of OTP visits attended | Standard Deviation 0.2181 |
| Oxytocin | Individual and Group Therapy Attendance Rates | Attendance Proportion: Week 3 | 0.9241 proportion of OTP visits attended | Standard Deviation 0.1652 |
| Oxytocin | Individual and Group Therapy Attendance Rates | Attendance Proportion: Week 6 | 0.9444 proportion of OTP visits attended | Standard Deviation 0.156 |
| Oxytocin | Individual and Group Therapy Attendance Rates | Attendance Proportion: Week 7 | 1 proportion of OTP visits attended | Standard Deviation 0 |
| Placebo | Individual and Group Therapy Attendance Rates | Attendance Proportion: Week 6 | 0.7483 proportion of OTP visits attended | Standard Deviation 0.3915 |
| Placebo | Individual and Group Therapy Attendance Rates | Attendance Proportion: Week 7 | 0.75 proportion of OTP visits attended | Standard Deviation 0.4443 |
| Placebo | Individual and Group Therapy Attendance Rates | Attendance Proportion: Week 1 | 0.8406 proportion of OTP visits attended | Standard Deviation 0.3047 |
| Placebo | Individual and Group Therapy Attendance Rates | Attendance Proportion: Week 2 | 0.8485 proportion of OTP visits attended | Standard Deviation 0.2951 |
| Placebo | Individual and Group Therapy Attendance Rates | Attendance Proportion: Week 3 | 0.8429 proportion of OTP visits attended | Standard Deviation 0.3022 |
| Placebo | Individual and Group Therapy Attendance Rates | Attendance Proportion: Week 4 | 0.7857 proportion of OTP visits attended | Standard Deviation 0.358 |
| Placebo | Individual and Group Therapy Attendance Rates | Attendance Proportion: Week 5 | 0.7476 proportion of OTP visits attended | Standard Deviation 0.3572 |
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.
Time frame: Visits 1 and 7, up to 7 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxytocin | Respiratory Rate in Response to Trier Social Stress Test (TSST). | Respiratory Rate Baseline: Week 1 | 10.9117 Breaths/minute | Standard Deviation 1.5119 |
| Oxytocin | Respiratory Rate in Response to Trier Social Stress Test (TSST). | Respiratory Rate During Speech Prep: Week 1 | 11.0512 Breaths/minute | Standard Deviation 3.3724 |
| Oxytocin | Respiratory Rate in Response to Trier Social Stress Test (TSST). | Respiratory Rate During Speech: Week 1 | 11.4533 Breaths/minute | Standard Deviation 2.976 |
| Oxytocin | Respiratory Rate in Response to Trier Social Stress Test (TSST). | Respiratory Rate During Arithmetic: Week 1 | 10.56 Breaths/minute | Standard Deviation 1.7841 |
| Oxytocin | Respiratory Rate in Response to Trier Social Stress Test (TSST). | Respiratory Rate Cooldown: Week 1 | 10.6278 Breaths/minute | Standard Deviation 3.0036 |
| Oxytocin | Respiratory Rate in Response to Trier Social Stress Test (TSST). | Respiratory Rate Baseline: Week 7 | 11.6779 Breaths/minute | Standard Deviation 3.795 |
| Oxytocin | Respiratory Rate in Response to Trier Social Stress Test (TSST). | Respiratory Rate During Speech Prep: Week 7 | 10.6251 Breaths/minute | Standard Deviation 1.8414 |
| Oxytocin | Respiratory Rate in Response to Trier Social Stress Test (TSST). | Respiratory Rate During Speech: Week 7 | 10.6675 Breaths/minute | Standard Deviation 3.0857 |
| Oxytocin | Respiratory Rate in Response to Trier Social Stress Test (TSST). | Respiratory Rate During Arithmetic: Week 7 | 10.4215 Breaths/minute | Standard Deviation 1.9839 |
| Oxytocin | Respiratory Rate in Response to Trier Social Stress Test (TSST). | Respiratory Rate Cooldown: Week 7 | 9.9913 Breaths/minute | Standard Deviation 2.6662 |
| Placebo | Respiratory Rate in Response to Trier Social Stress Test (TSST). | Respiratory Rate During Speech: Week 7 | 11.5526 Breaths/minute | Standard Deviation 3.304 |
| Placebo | Respiratory Rate in Response to Trier Social Stress Test (TSST). | Respiratory Rate Baseline: Week 1 | 11.2000 Breaths/minute | Standard Deviation 2.9642 |
| Placebo | Respiratory Rate in Response to Trier Social Stress Test (TSST). | Respiratory Rate Baseline: Week 7 | 11.4583 Breaths/minute | Standard Deviation 2.3595 |
| Placebo | Respiratory Rate in Response to Trier Social Stress Test (TSST). | Respiratory Rate During Speech Prep: Week 1 | 12.292 Breaths/minute | Standard Deviation 2.9966 |
| Placebo | Respiratory Rate in Response to Trier Social Stress Test (TSST). | Respiratory Rate Cooldown: Week 7 | 10.3816 Breaths/minute | Standard Deviation 2.9001 |
| Placebo | Respiratory Rate in Response to Trier Social Stress Test (TSST). | Respiratory Rate During Speech: Week 1 | 12.3352 Breaths/minute | Standard Deviation 2.9521 |
| Placebo | Respiratory Rate in Response to Trier Social Stress Test (TSST). | Respiratory Rate During Speech Prep: Week 7 | 12.7914 Breaths/minute | Standard Deviation 3.7546 |
| Placebo | Respiratory Rate in Response to Trier Social Stress Test (TSST). | Respiratory Rate During Arithmetic: Week 1 | 11.7565 Breaths/minute | Standard Deviation 3.5337 |
| Placebo | Respiratory Rate in Response to Trier Social Stress Test (TSST). | Respiratory Rate During Arithmetic: Week 7 | 12.4459 Breaths/minute | Standard Deviation 2.4201 |
| Placebo | Respiratory Rate in Response to Trier Social Stress Test (TSST). | Respiratory Rate Cooldown: Week 1 | 10.5266 Breaths/minute | Standard Deviation 2.1028 |
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.
Time frame: Visits 1 and 7, up to 7 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxytocin | Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST). | Respiratory Sinus Arrythmia During Baseline: Week 1 | 4.2435 milliseconds squared | Standard Deviation 1.2701 |
| Oxytocin | Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST). | Respiratory Sinus Arrythmia During Speech Prep: Week 1 | 4.6264 milliseconds squared | Standard Deviation 1.2903 |
| Oxytocin | Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST). | Respiratory Sinus Arrythmia During Speech: Week 1 | 3.5542 milliseconds squared | Standard Deviation 1.2285 |
| Oxytocin | Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST). | Respiratory Sinus Arrythmia During Arithmetic: Week 1 | 3.5364 milliseconds squared | Standard Deviation 1.1521 |
| Oxytocin | Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST). | Respiratory Sinus Arrythmia During Cooldown: Week1 | 4.3466 milliseconds squared | Standard Deviation 1.0783 |
| Oxytocin | Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST). | Respiratory Sinus Arrythmia During Baseline: Week 7 | 4.1866 milliseconds squared | Standard Deviation 1.1912 |
| Oxytocin | Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST). | Respiratory Sinus Arrythmia During Speech Prep: Week 7 | 4.0099 milliseconds squared | Standard Deviation 1.3911 |
| Oxytocin | Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST). | Respiratory Sinus Arrythmia During Speech: Week 7 | 3.6254 milliseconds squared | Standard Deviation 1.366 |
| Oxytocin | Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST). | Respiratory Sinus Arrythmia During Arithmetic: Week 7 | 3.4825 milliseconds squared | Standard Deviation 1.3147 |
| Oxytocin | Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST). | Respiratory Sinus Arrythmia During Cooldown: Week 7 | 3.9752 milliseconds squared | Standard Deviation 1.4793 |
| Placebo | Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST). | Respiratory Sinus Arrythmia During Speech: Week 7 | 3.5998 milliseconds squared | Standard Deviation 1.523 |
| Placebo | Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST). | Respiratory Sinus Arrythmia During Baseline: Week 1 | 4.9543 milliseconds squared | Standard Deviation 1.8461 |
| Placebo | Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST). | Respiratory Sinus Arrythmia During Baseline: Week 7 | 4.053 milliseconds squared | Standard Deviation 1.7715 |
| Placebo | Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST). | Respiratory Sinus Arrythmia During Speech Prep: Week 1 | 4.7393 milliseconds squared | Standard Deviation 1.5292 |
| Placebo | Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST). | Respiratory Sinus Arrythmia During Cooldown: Week 7 | 4.1651 milliseconds squared | Standard Deviation 1.5196 |
| Placebo | Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST). | Respiratory Sinus Arrythmia During Speech: Week 1 | 3.8212 milliseconds squared | Standard Deviation 1.3293 |
| Placebo | Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST). | Respiratory Sinus Arrythmia During Speech Prep: Week 7 | 4.2972 milliseconds squared | Standard Deviation 1.685 |
| Placebo | Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST). | Respiratory Sinus Arrythmia During Arithmetic: Week 1 | 3.7893 milliseconds squared | Standard Deviation 1.1818 |
| Placebo | Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST). | Respiratory Sinus Arrythmia During Arithmetic: Week 7 | 3.5267 milliseconds squared | Standard Deviation 1.3283 |
| Placebo | Respiratory Sinus Arrythmia (RSA) in Response to Trier Social Stress Test (TSST). | Respiratory Sinus Arrythmia During Cooldown: Week1 | 4.4933 milliseconds squared | Standard Deviation 1.3137 |
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.
Time frame: Visits 1 and 7, up to 7 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxytocin | Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST). | RMSSD During Baseline: Week 1 | 26.8196 milliseconds | Standard Deviation 41.5701 |
| Oxytocin | Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST). | RMSSD During Speech Prep: Week 1 | 28.5447 milliseconds | Standard Deviation 38.5287 |
| Oxytocin | Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST). | RMSSD During Speech: Week 1 | 22.5526 milliseconds | Standard Deviation 44.3238 |
| Oxytocin | Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST). | RMSSD During Arithmetic: Week 1 | 21.113 milliseconds | Standard Deviation 39.347 |
| Oxytocin | Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST). | RMSSD During Cooldown: Week 1 | 29.7325 milliseconds | Standard Deviation 53.4858 |
| Oxytocin | Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST). | RMSSD During Baseline Week 7 | 15.7941 milliseconds | Standard Deviation 9.0513 |
| Oxytocin | Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST). | RMSSD During Speech Prep: Week 7 | 16.0198 milliseconds | Standard Deviation 9.2258 |
| Oxytocin | Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST). | RMSSD During Speech: Week 7 | 12.9299 milliseconds | Standard Deviation 7.5432 |
| Oxytocin | Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST). | RMSSD During Arithmetic: Week 7 | 11.3174 milliseconds | Standard Deviation 6.5779 |
| Oxytocin | Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST). | RMSSD During Cooldown: Week 7 | 17.9728 milliseconds | Standard Deviation 13.0228 |
| Placebo | Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST). | RMSSD During Speech: Week 7 | 22.1121 milliseconds | Standard Deviation 30.6961 |
| Placebo | Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST). | RMSSD During Baseline: Week 1 | 48.865 milliseconds | Standard Deviation 48.2147 |
| Placebo | Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST). | RMSSD During Baseline Week 7 | 26.3299 milliseconds | Standard Deviation 30.7912 |
| Placebo | Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST). | RMSSD During Speech Prep: Week 1 | 37.7607 milliseconds | Standard Deviation 44.6989 |
| Placebo | Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST). | RMSSD During Cooldown: Week 7 | 24.6587 milliseconds | Standard Deviation 20.8481 |
| Placebo | Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST). | RMSSD During Speech: Week 1 | 20.9388 milliseconds | Standard Deviation 21.2336 |
| Placebo | Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST). | RMSSD During Speech Prep: Week 7 | 28.1708 milliseconds | Standard Deviation 31.7601 |
| Placebo | Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST). | RMSSD During Arithmetic: Week 1 | 21.1729 milliseconds | Standard Deviation 18.4126 |
| Placebo | Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST). | RMSSD During Arithmetic: Week 7 | 21.2057 milliseconds | Standard Deviation 32.3207 |
| Placebo | Root Mean Square of Successive Differences (RMSSD) of Heart Rate Variability in Response to Trier Social Stress Test (TSST). | RMSSD During Cooldown: Week 1 | 34.5220 milliseconds | Standard Deviation 43.9497 |
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.
Time frame: Visits 1 and 7, Up to 7 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxytocin | Self-reported Stimulant Craving | Pre_Trier: Week 1 | 2.1667 score on a scale | Standard Deviation 1.1827 |
| Oxytocin | Self-reported Stimulant Craving | Imm_Post_Trier: Week 1 | 2.4389 score on a scale | Standard Deviation 1.7446 |
| Oxytocin | Self-reported Stimulant Craving | 20m_Post_Trier: Week 1 | 2.3056 score on a scale | Standard Deviation 1.4941 |
| Oxytocin | Self-reported Stimulant Craving | Pre_Trier: Week 7 | 1.7167 score on a scale | Standard Deviation 1.0755 |
| Oxytocin | Self-reported Stimulant Craving | Imm_Post_Trier: Week 7 | 1.6833 score on a scale | Standard Deviation 0.8535 |
| Oxytocin | Self-reported Stimulant Craving | 20m_Post_Trier: Week 7 | 1.7167 score on a scale | Standard Deviation 1.058 |
| Placebo | Self-reported Stimulant Craving | Imm_Post_Trier: Week 7 | 1.48 score on a scale | Standard Deviation 0.818 |
| Placebo | Self-reported Stimulant Craving | Pre_Trier: Week 1 | 1.82727 score on a scale | Standard Deviation 1.1707 |
| Placebo | Self-reported Stimulant Craving | Pre_Trier: Week 7 | 1.42 score on a scale | Standard Deviation 0.7135 |
| Placebo | Self-reported Stimulant Craving | Imm_Post_Trier: Week 1 | 2.35 score on a scale | Standard Deviation 1.6964 |
| Placebo | Self-reported Stimulant Craving | 20m_Post_Trier: Week 7 | 1.67 score on a scale | Standard Deviation 1.0255 |
| Placebo | Self-reported Stimulant Craving | 20m_Post_Trier: Week 1 | 1.8955 score on a scale | Standard Deviation 1.2688 |
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.
Time frame: Visits 1 and 7, Up to 7 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxytocin | Self-reported Stress/Anxiety | Pre_Trier: Week 1 | 34.815 score on a scale | Standard Deviation 13.778 |
| Oxytocin | Self-reported Stress/Anxiety | Imm_Post_Trier: Week 1 | 46.4815 score on a scale | Standard Deviation 15.529 |
| Oxytocin | Self-reported Stress/Anxiety | 20m_Post_Trier: Week 1 | 36.8519 score on a scale | Standard Deviation 14.4834 |
| Oxytocin | Self-reported Stress/Anxiety | Pre_Trier: Week 7 | 35.185 score on a scale | Standard Deviation 12.379 |
| Oxytocin | Self-reported Stress/Anxiety | Imm_Post_Trier: Week 7 | 42.222 score on a scale | Standard Deviation 15.966 |
| Oxytocin | Self-reported Stress/Anxiety | 20m_Post_Trier: Week 7 | 35.741 score on a scale | Standard Deviation 11.871 |
| Placebo | Self-reported Stress/Anxiety | Imm_Post_Trier: Week 7 | 36.5 score on a scale | Standard Deviation 11.7217 |
| Placebo | Self-reported Stress/Anxiety | Pre_Trier: Week 1 | 32.2727 score on a scale | Standard Deviation 11.0978 |
| Placebo | Self-reported Stress/Anxiety | Pre_Trier: Week 7 | 29.17 score on a scale | Standard Deviation 11.38 |
| Placebo | Self-reported Stress/Anxiety | Imm_Post_Trier: Week 1 | 46.0606 score on a scale | Standard Deviation 19.29 |
| Placebo | Self-reported Stress/Anxiety | 20m_Post_Trier: Week 7 | 31 score on a scale | Standard Deviation 11.726 |
| Placebo | Self-reported Stress/Anxiety | 20m_Post_Trier: Week 1 | 36.97 score on a scale | Standard Deviation 14.5809 |
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.
Time frame: Visits 1 and 7, Up to 7 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oxytocin | Working Alliance Inventory (WAI) | WAI Week 1:Therapist | 4.088 score on a scale | Standard Deviation 0.7048 |
| Oxytocin | Working Alliance Inventory (WAI) | WAI Week 1: Self-Report | 3.5972 score on a scale | Standard Deviation 0.8816 |
| Oxytocin | Working Alliance Inventory (WAI) | WAI Week 7: Therapist | 4.1450 score on a scale | Standard Deviation 0.7334 |
| Oxytocin | Working Alliance Inventory (WAI) | WAI Week 7: Self-Report | 3.4676 score on a scale | Standard Deviation 0.785 |
| Placebo | Working Alliance Inventory (WAI) | WAI Week 7: Therapist | 3.7486 score on a scale | Standard Deviation 0.8308 |
| Placebo | Working Alliance Inventory (WAI) | WAI Week 1:Therapist | 3.754 score on a scale | Standard Deviation 0.737 |
| Placebo | Working Alliance Inventory (WAI) | WAI Week 7: Self-Report | 3.5208 score on a scale | Standard Deviation 1.0516 |
| Placebo | Working Alliance Inventory (WAI) | WAI Week 1: Self-Report | 3.8182 score on a scale | Standard Deviation 0.8107 |