Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1IK2CX001495-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal oxytocin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christopher Stauffer, MD | San Francisco VA Medical Center, San Francisco, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Northern California Health Care System, Mather, CA | Sacramento | California | 95655 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25295428 | Background | 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. No abstract available. |
| Label | URL |
|---|---|
| Social Neuroscience \& Psychotherapy Lab | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
42 individuals were enrolled, 2 of which were excluded due to being lost to follow up before being assigned to an arm.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Oxytocin | 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. Intranasal oxytocin: Each Veteran with a stimulant use disorder, receiving MMT for OUD will receive a oxytocin 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. |
| FG001 | 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. Intranasal 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Stimulant Positive Drug Screen | Aim 1: To evaluate the effectiveness of intranasal oxytocin on reducing stimulant use. | Posted | Count of Participants | Participants | Baseline, Visits 1-7, up to 7 weeks |
|
18 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Systematic Assessment | Participant (Subject Identifier (ID)# 730) was admitted to the San Francisco Veteran Affairs (SFVA) ER for constipation on 3/30/2019 and 4/10/2019. He was discharged on the same day for both events. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Delaney.McKechnie@va.gov | Portland VA | 360-696-4061 | 32017 | Delaney.McKechnie@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 18, 2017 | Feb 17, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 2, 2016 | Feb 17, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 8, 2019 | Feb 17, 2021 | ICF_002.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Intranasal placebo | Drug | 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. |
|
|
| Visits 1 and 7, Up to 7 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| San Francisco VA Medical Center, San Francisco, CA |
| San Francisco |
| California |
| 94121 |
| United States |
| VA Portland Health Care System, Portland, OR | Portland | Oregon | 97239 | United States |
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | Beats/minute | 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. | Posted | Mean | Standard Deviation | Breaths/minute | 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. | Posted | Mean | Standard Deviation | milliseconds squared | 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. | Posted | Mean | Standard Deviation | milliseconds | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | proportion of OTP visits attended | 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. | Posted | Mean | Standard Deviation | (ug/dL) | 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. | Posted | Mean | Standard Deviation | (pg/mL) | 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. | Posted | Mean | Standard Deviation | score on a scale | Visits 1 and 7, Up to 7 weeks |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 1 |
| 18 |
| EG001 | 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. | 0 | 22 | 0 | 22 | 1 | 22 |
|
| Stinging sensation | Skin and subcutaneous tissue disorders | Systematic Assessment | Participant (Subject ID# 730) reported a stinging sensation and was examined by study physician, who did not observe irritation. Participant said sensation subsided, and remarked. 'It must've been a zit'. |
|
| Hallucination | Psychiatric disorders | Systematic Assessment | Participant (Subject ID# 731) reported dream-like hallucination that subsided after 2 seconds. Participant reported methamphetamine use prior to hallucination, and the event did not result in participant injury. |
|
Not provided
Not provided
Not provided
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| WAI Week 1:Therapist |
|
| WAI Week 7: Therapist |
|
| Heart Rate During Speech: Week 1 |
|
| Heart Rate During Arithmetic: Week 1 |
|
| Heart Rate Cooldown: Week 1 |
|
| Heart Rate Baseline: Week 7 |
|
| Heart Rate During Speech Prep: Week 7 |
|
| Heart Rate During Speech: Week 7 |
|
| Heart Rate During Arithmetic: Week 7 |
|
| Heart Rate Cooldown: Week 7 |
|
| Respiratory Rate During Speech: Week 1 |
|
| Respiratory Rate During Arithmetic: Week 1 |
|
| Respiratory Rate Cooldown: Week 1 |
|
| Respiratory Rate Baseline: Week 7 |
|
| Respiratory Rate During Speech Prep: Week 7 |
|
| Respiratory Rate During Speech: Week 7 |
|
| Respiratory Rate During Arithmetic: Week 7 |
|
| Respiratory Rate Cooldown: Week 7 |
|
| Respiratory Sinus Arrythmia During Speech: Week 1 |
|
| Respiratory Sinus Arrythmia During Arithmetic: Week 1 |
|
| Respiratory Sinus Arrythmia During Cooldown: Week1 |
|
| Respiratory Sinus Arrythmia During Baseline: Week 7 |
|
| Respiratory Sinus Arrythmia During Speech Prep: Week 7 |
|
| Respiratory Sinus Arrythmia During Speech: Week 7 |
|
| Respiratory Sinus Arrythmia During Arithmetic: Week 7 |
|
| Respiratory Sinus Arrythmia During Cooldown: Week 7 |
|
| RMSSD During Speech: Week 1 |
|
| RMSSD During Arithmetic: Week 1 |
|
| RMSSD During Cooldown: Week 1 |
|
| RMSSD During Baseline Week 7 |
|
| RMSSD During Speech Prep: Week 7 |
|
| RMSSD During Speech: Week 7 |
|
| RMSSD During Arithmetic: Week 7 |
|
| RMSSD During Cooldown: Week 7 |
|
| 20m_Post_Trier: Week 1 |
|
| Pre_Trier: Week 7 |
|
| Imm_Post_Trier: Week 7 |
|
| 20m_Post_Trier: Week 7 |
|
| Attendance Proportion: Week 3 |
|
| Attendance Proportion: Week 4 |
|
| Attendance Proportion: Week 5 |
|
| Attendance Proportion: Week 6 |
|
| Attendance Proportion: Week 7 |
|
| Immediately Post-Trier Cortisol Levels (ug/dL) Week 1 |
|
| 20Minutes Post-Trier Cortisol Levels (ug/dL) Week 1 |
|
| Initial Cortisol Levels (ug/dL) Week 7 |
|
| Pre-Trier Cortisol Levels (ug/dL) Week 7 |
|
| Immediately Post-Trier Cortisol Levels (ug/dL) Week 7 |
|
| 20 Minutes Post-Trier Cortisol Levels (ug/dL) Week 7 |
|
| Immediately Post-Trier DHEA Levels (pg/mL) Week 1 |
|
| 20 Minutes Post-Trier DHEA Levels (pg/mL) Week 1 |
|
| Initial DHEA Levels(pg/mL) Week 7 |
|
| Pre-Trier DHEA Levels (pg/mL) Week 7 |
|
| Immediately Post-Trier DHEA Levels (pg/mL) Week 7 |
|
| 20 Minutes Post-Trier DHEA Levels (pg/mL) Week 7 |
|
| 20m_Post_Trier: Week 1 |
|
| Pre_Trier: Week 7 |
|
| Imm_Post_Trier: Week 7 |
|
| 20m_Post_Trier: Week 7 |
|