Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Peter McManus Charitable Trust | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the effectiveness of a medication called suvorexant in reducing anxiety, improving sleep, and reducing cocaine cravings or cocaine use.
Preclinical research has established important functions for the orexin system in mediating arousal/sleep, stress, and cue-induced reinstatement of drug taking (e.g., relapse). The role of stress/anxiety and drug cue reactivity in human drug relapse is well established, but to date, the role of the orexin system in modulating these phenomena has not been examined in humans with substance use disorders (e.g., cocaine). The goal of the present first-in-human study will be to examine the effects of an orexin antagonist (suvorexant) on interactions among stress/anxiety, sleep, and drug-cue reactivity. The study will utilize a battery of highly sensitive, drug-specific, laboratory measures of drug cue reactivity (a relapse risk model), and well-established metrics of stress/anxiety and sleep. The hypothesis is that antagonism of the orexin system will attenuate the link between (1) stress/anxiety and drug cue reactivity, and (2) sleep and drug cue reactivity. These results will elucidate a unique biochemical mechanism for understanding relapse, and provide a potential medication target for relapse prevention.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| suvorexant | Experimental | Subjects will receive suvorexant (10 mg week 1, 20 mg week 2), once daily at 10 PM. |
|
| Placebo | Placebo Comparator | Subjects will receive placebo once daily at 10 PM. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| suvorexant | Drug | Subjects will receive suvorexant capsules (10 mg week 1, 20 mg week 2), once daily at 10 PM. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cue Reactivity as Assessed by the Attention Bias (AB) Task | The attention bias (AB) task is a saccade-based eye-tracking measurement, developed by the PI to assess attentional bias to drug cues. AB measures utilizing eye movements have produced moderate to robust effects for a broad class abused substances, including cocaine. The score ranges from 0 to 1. Higher scores indicate a worse outcome. | day 0 |
| Cue Reactivity as Assessed by the Attention Bias (AB) Task | The attention bias (AB) task is a saccade-based eye-tracking measurement, developed by the PI to assess attentional bias to drug cues. AB measures utilizing eye movements have produced moderate to robust effects for a broad class abused substances, including cocaine. The score ranges from 0 to 1. Higher scores indicate a worse outcome. | day 7 |
| Cue Reactivity as Assessed by the Attention Bias (AB) Task | The attention bias (AB) task is a saccade-based eye-tracking measurement, developed by the PI to assess attentional bias to drug cues. AB measures utilizing eye movements have produced moderate to robust effects for a broad class abused substances, including cocaine. The score ranges from 0 to 1. Higher scores indicate a worse outcome. | day 14 |
| Total Sleep as Assessed by the Misfit Shine Device | Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth. | day 0 |
| Total Sleep as Assessed by the Misfit Shine Device | Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth. |
| Measure | Description | Time Frame |
|---|---|---|
| Cue Reactivity as Assessed by the Cocaine Craving Questionnaire (CCQ) Brief | The Cocaine Craving Questionnaire (CCQ) Brief is a self-report, 14-item measure with five conceptual domains: Desire to Use, Intention to Use, Anticipation of Positive Outcome, Anticipation of Relief from Dysphoria, and Lack of Control over use. The measure is well validated and has been used in multiple studies of CUD. Total score ranges from 1 to 7. A higher score indicates a worse outcome. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Scott D. Lane, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Suvorexant | Subjects will receive suvorexant (10 mg week 1, 20 mg week 2), once daily at 10 PM. suvorexant: Subjects will receive suvorexant capsules (10 mg week 1, 20 mg week 2), once daily at 10 PM. |
| FG001 | Placebo | Subjects will receive placebo once daily at 10 PM. Placebo (for suvorexant): Subjects will receive placebo capsules once daily at 10 PM. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Suvorexant | Subjects will receive suvorexant (10 mg week 1, 20 mg week 2), once daily at 10 PM. suvorexant: Subjects will receive suvorexant capsules (10 mg week 1, 20 mg week 2), once daily at 10 PM. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Cue Reactivity as Assessed by the Attention Bias (AB) Task | The attention bias (AB) task is a saccade-based eye-tracking measurement, developed by the PI to assess attentional bias to drug cues. AB measures utilizing eye movements have produced moderate to robust effects for a broad class abused substances, including cocaine. The score ranges from 0 to 1. Higher scores indicate a worse outcome. | Data were not collected for 1 in the placebo arm. | Posted | Mean | Standard Deviation | score on a scale | day 0 |
|
14 days
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 | Suvorexant | Subjects will receive suvorexant (10 mg week 1, 20 mg week 2), once daily at 10 PM. suvorexant: Subjects will receive suvorexant capsules (10 mg week 1, 20 mg week 2), once daily at 10 PM. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Lane | The University of Texas Health Science Center at Houston | 713-486-2535 | Scott.D.Lane@uth.tmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 25, 2017 | Nov 10, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| C551624 | suvorexant |
| D013213 | Starch |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo (for suvorexant) | Drug | Subjects will receive placebo capsules once daily at 10 PM. |
|
|
| day 2 |
| Total Sleep as Assessed by the Misfit Shine Device | Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth. | day 4 |
| Total Sleep as Assessed by the Misfit Shine Device | Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth. | day 7 |
| Total Sleep as Assessed by the Misfit Shine Device | Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth. | day 9 |
| Total Sleep as Assessed by the Misfit Shine Device | Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth. | day 11 |
| Total Sleep as Assessed by the Misfit Shine Device | Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth. | day 14 |
| Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome. | day 0 |
| Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome. | day 2 |
| Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome. | day 4 |
| Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome. | day 7 |
| Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome. | day 9 |
| Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome. | day 11 |
| Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome. | day 14 |
| Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale. | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome. | day 0 |
| Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome. | day 2 |
| Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome. | day 4 |
| Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome. | day 7 |
| Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome. | day 9 |
| Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome. | day 11 |
| Anxiety as Assessed by the DASS21 Self-report Questionnaire | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome. | day 14 |
| day 0, day 7, and day 14 |
| Sleep Quality as by the Pittsburg Sleep Quality Index (PSQI) | The Pittsburg Sleep Quality Index (PSQI) is an 18-item self-report measure of sleep, providing a well-validated and reliable measure of sleep quality, latency, duration, duration efficiency, and disturbance, and an overall summary. The overall summary score will be reported for this measure. The PSQI has been used in several studies of individuals with SUD, including cocaine. Total score ranges from 0-21, with a higher score indicating worse outcome. | day 0, day 2, day 4, day 7, day 9, day 11, and day 14 |
| Stress/Anxiety as Assessed by Blood Pressure During the Cold Pressor Test (CPT) - Systolic Blood Pressure | Cold Pressor Test (CPT) reliably increases activity of the sympathetic nervous system and the HPA axis, and produces reliable increases in heart rate and cortisol. Subjects are requested to submerge the dominant arm up to the wrist or elbow in ice-cold water (0° to 4° C) for as long as possible with a maximum of 90 seconds. The procedure activates afferent nerves and elicits a CNS stress response. This procedure produces no lasting biological or psychological distress beyond the acute challenge period, and physiological effects return to baseline within 90 min. In fact, the CPT is used to study pain in children, and is considered a noninvasive, exempt educational experimental activity by the IRB of the University of Texas-Austin. It has been used extensively in cardiology, endocrinology, psychiatry, and psychology since 1940 as a challenge to the peripheral and central stress axis | day 0, day 7, and day 14 |
| Stress/Anxiety as Assessed by Blood Pressure During the Cold Pressor Test (CPT) - Diastolic Blood Pressure | Cold Pressor Test (CPT) reliably increases activity of the sympathetic nervous system and the HPA axis, and produces reliable increases in heart rate and cortisol. Subjects are requested to submerge the dominant arm up to the wrist or elbow in ice-cold water (0° to 4° C) for as long as possible with a maximum of 90 seconds. The procedure activates afferent nerves and elicits a CNS stress response. This procedure produces no lasting biological or psychological distress beyond the acute challenge period, and physiological effects return to baseline within 90 min. In fact, the CPT is used to study pain in children, and is considered a noninvasive, exempt educational experimental activity by the IRB of the University of Texas-Austin. It has been used extensively in cardiology, endocrinology, psychiatry, and psychology since 1940 as a challenge to the peripheral and central stress axis. | day 0, day 7, and day 14 |
| Stress/Anxiety as Assessed by Cortisol Level During the Cold Pressor Test (CPT) | Cold Pressor Test (CPT) reliably increases activity of the sympathetic nervous system and the HPA axis, and produces reliable increases in heart rate and cortisol. Subjects are requested to submerge the dominant arm up to the wrist or elbow in ice-cold water (0° to 4° C) for as long as possible with a maximum of 90 seconds. The procedure activates afferent nerves and elicits a CNS stress response. This procedure produces no lasting biological or psychological distress beyond the acute challenge period, and physiological effects return to baseline within 90 min. In fact, the CPT is used to study pain in children, and is considered a noninvasive, exempt educational experimental activity by the IRB of the University of Texas-Austin. It has been used extensively in cardiology, endocrinology, psychiatry, and psychology since 1940 as a challenge to the peripheral and central stress axis. | day 0, day 7, and day 14 |
| Stress as Assessed by a Visual Analog Scale (VAS) for Stress | Score provided is the total score (0 to 300) across three items that are each on a 0-100 scale. A higher score indicates greater stress. | day 0, day 2, day 4, day 7, day 9, day 11, and day 14 |
| Percent Medication Compliance as Assessed by the Medical Event Monitoring System (MEMS, Aprex Corporation) Bottles | day 2, day 4, day 7, day 9, day 11, and day 14 |
| Percent Medication Compliance as Assessed by Pill Counts | day 2, day 4, day 7, day 9, day 11, and day 14 |
| Percent Medication Compliance as Assessed by Analysis of Riboflavin Markers in Urine Samples | day 2, day 4, day 7, day 9, day 11, and day 14 |
| Percent Medication Compliance as Assessed by Text Reminders and Replies | Text-based reminders to take the medication will be enabled via using a HIPAA secure texting service (Talksoft ©), used broadly in medical settings. Participants will be prompted each night at 10 PM to take their medication, and instructed to text back "yes" when they have taken their medication. | day 2, day 4, day 7, day 9, day 11, and day 14 |
Subjects will receive placebo once daily at 10 PM.
Placebo (for suvorexant): Subjects will receive placebo capsules once daily at 10 PM.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Subjects will receive placebo once daily at 10 PM. Placebo (for suvorexant): Subjects will receive placebo capsules once daily at 10 PM. |
|
|
| Primary | Cue Reactivity as Assessed by the Attention Bias (AB) Task | The attention bias (AB) task is a saccade-based eye-tracking measurement, developed by the PI to assess attentional bias to drug cues. AB measures utilizing eye movements have produced moderate to robust effects for a broad class abused substances, including cocaine. The score ranges from 0 to 1. Higher scores indicate a worse outcome. | Data were not collected for one in the suvorexant arm and one in the placebo arm. | Posted | Mean | Standard Deviation | score on a scale | day 7 |
|
|
|
| Primary | Cue Reactivity as Assessed by the Attention Bias (AB) Task | The attention bias (AB) task is a saccade-based eye-tracking measurement, developed by the PI to assess attentional bias to drug cues. AB measures utilizing eye movements have produced moderate to robust effects for a broad class abused substances, including cocaine. The score ranges from 0 to 1. Higher scores indicate a worse outcome. | Data were not collected for one in the placebo arm. | Posted | Mean | Standard Deviation | score on a scale | day 14 |
|
|
|
| Primary | Total Sleep as Assessed by the Misfit Shine Device | Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth. | Data were not collected for one in the suvorexant arm and 5 in the placebo arm. | Posted | Mean | Standard Deviation | hours | day 0 |
|
|
|
| Primary | Total Sleep as Assessed by the Misfit Shine Device | Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth. | Data were not collected for 2 in the suvorexant arm and 4 in the placebo arm. | Posted | Mean | Standard Deviation | hours | day 2 |
|
|
|
| Primary | Total Sleep as Assessed by the Misfit Shine Device | Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth. | Data were not collected for 4 in the suvorexant arm and 4 in the placebo arm. | Posted | Mean | Standard Deviation | hours | day 4 |
|
|
|
| Primary | Total Sleep as Assessed by the Misfit Shine Device | Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth. | Data were not collected for one in the suvorexant arm and 4 in the placebo arm. | Posted | Mean | Standard Deviation | hours | day 7 |
|
|
|
| Primary | Total Sleep as Assessed by the Misfit Shine Device | Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth. | Data were not collected for 2 in the suvorexant arm and 4 in the placebo arm. | Posted | Mean | Standard Deviation | hours | day 9 |
|
|
|
| Primary | Total Sleep as Assessed by the Misfit Shine Device | Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth. | Data were not collected for 4 in the suvorexant arm and 4 in the placebo arm. | Posted | Mean | Standard Deviation | hours | day 11 |
|
|
|
| Primary | Total Sleep as Assessed by the Misfit Shine Device | Sleep activity is monitored with a 3-axis accelerometer inside the watch device (Misfit Shine), using a general heuristic based on time and motion. The device is waterproof and worn on the wrist 24 hrs per day. Data are downloaded to smartphone via Bluetooth. | Data were not collected for 3 in the suvorexant arm and 5 in the placebo arm. | Posted | Mean | Standard Deviation | hours | day 14 |
|
|
|
| Primary | Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome. | Posted | Mean | Standard Deviation | score on a scale | day 0 |
|
|
|
| Primary | Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome. | Posted | Mean | Standard Deviation | score on a scale | day 2 |
|
|
|
| Primary | Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome. | Posted | Mean | Standard Deviation | score on a scale | day 4 |
|
|
|
| Primary | Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome. | Posted | Mean | Standard Deviation | score on a scale | day 7 |
|
|
|
| Primary | Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome. | Posted | Mean | Standard Deviation | score on a scale | day 9 |
|
|
|
| Primary | Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome. | Posted | Mean | Standard Deviation | score on a scale | day 11 |
|
|
|
| Primary | Stress as Assessed by the DASS21 Self-report Questionnaire Stress Subscale | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the stress subscale is 0 to 42, with higher scores indicating worse outcome. | Posted | Mean | Standard Deviation | score on a scale | day 14 |
|
|
|
| Primary | Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale. | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome. | Posted | Mean | Standard Deviation | score on a scale | day 0 |
|
|
|
| Primary | Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome. | Posted | Mean | Standard Deviation | score on a scale | day 2 |
|
|
|
| Primary | Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome. | Posted | Mean | Standard Deviation | score on a scale | day 4 |
|
|
|
| Primary | Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome. | Posted | Mean | Standard Deviation | score on a scale | day 7 |
|
|
|
| Primary | Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome. | Posted | Mean | Standard Deviation | score on a scale | day 9 |
|
|
|
| Primary | Anxiety as Assessed by the DASS21 Self-report Questionnaire Anxiety Subscale | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome. | Posted | Mean | Standard Deviation | score on a scale | day 11 |
|
|
|
| Primary | Anxiety as Assessed by the DASS21 Self-report Questionnaire | DASS21 is a 21-item self-report questionnaire assessing the severity of clinically agreed upon core depression, anxiety, and stress symptoms. It is well validated in multiple languages and countries, and has been utilized in SUD treatment and withdrawal studies. Total score on the anxiety subscale is 0 to 42, with higher scores indicating worse outcome. | Posted | Mean | Standard Deviation | score on a scale | day 14 |
|
|
|
| Secondary | Cue Reactivity as Assessed by the Cocaine Craving Questionnaire (CCQ) Brief | The Cocaine Craving Questionnaire (CCQ) Brief is a self-report, 14-item measure with five conceptual domains: Desire to Use, Intention to Use, Anticipation of Positive Outcome, Anticipation of Relief from Dysphoria, and Lack of Control over use. The measure is well validated and has been used in multiple studies of CUD. Total score ranges from 1 to 7. A higher score indicates a worse outcome. | Posted | Mean | Standard Deviation | score on a scale | day 0, day 7, and day 14 |
|
|
|
| Secondary | Sleep Quality as by the Pittsburg Sleep Quality Index (PSQI) | The Pittsburg Sleep Quality Index (PSQI) is an 18-item self-report measure of sleep, providing a well-validated and reliable measure of sleep quality, latency, duration, duration efficiency, and disturbance, and an overall summary. The overall summary score will be reported for this measure. The PSQI has been used in several studies of individuals with SUD, including cocaine. Total score ranges from 0-21, with a higher score indicating worse outcome. | Data were not collected for days 2, 4, 9, and 11. For days 0, 7, and 14, where number analyzed is less than 10, data were not collected for the number that are not reported. | Posted | Mean | Standard Deviation | score on a scale | day 0, day 2, day 4, day 7, day 9, day 11, and day 14 |
|
|
|
| Secondary | Stress/Anxiety as Assessed by Blood Pressure During the Cold Pressor Test (CPT) - Systolic Blood Pressure | Cold Pressor Test (CPT) reliably increases activity of the sympathetic nervous system and the HPA axis, and produces reliable increases in heart rate and cortisol. Subjects are requested to submerge the dominant arm up to the wrist or elbow in ice-cold water (0° to 4° C) for as long as possible with a maximum of 90 seconds. The procedure activates afferent nerves and elicits a CNS stress response. This procedure produces no lasting biological or psychological distress beyond the acute challenge period, and physiological effects return to baseline within 90 min. In fact, the CPT is used to study pain in children, and is considered a noninvasive, exempt educational experimental activity by the IRB of the University of Texas-Austin. It has been used extensively in cardiology, endocrinology, psychiatry, and psychology since 1940 as a challenge to the peripheral and central stress axis | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | day 0, day 7, and day 14 |
|
|
|
| Secondary | Stress/Anxiety as Assessed by Blood Pressure During the Cold Pressor Test (CPT) - Diastolic Blood Pressure | Cold Pressor Test (CPT) reliably increases activity of the sympathetic nervous system and the HPA axis, and produces reliable increases in heart rate and cortisol. Subjects are requested to submerge the dominant arm up to the wrist or elbow in ice-cold water (0° to 4° C) for as long as possible with a maximum of 90 seconds. The procedure activates afferent nerves and elicits a CNS stress response. This procedure produces no lasting biological or psychological distress beyond the acute challenge period, and physiological effects return to baseline within 90 min. In fact, the CPT is used to study pain in children, and is considered a noninvasive, exempt educational experimental activity by the IRB of the University of Texas-Austin. It has been used extensively in cardiology, endocrinology, psychiatry, and psychology since 1940 as a challenge to the peripheral and central stress axis. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | day 0, day 7, and day 14 |
|
|
|
| Secondary | Stress/Anxiety as Assessed by Cortisol Level During the Cold Pressor Test (CPT) | Cold Pressor Test (CPT) reliably increases activity of the sympathetic nervous system and the HPA axis, and produces reliable increases in heart rate and cortisol. Subjects are requested to submerge the dominant arm up to the wrist or elbow in ice-cold water (0° to 4° C) for as long as possible with a maximum of 90 seconds. The procedure activates afferent nerves and elicits a CNS stress response. This procedure produces no lasting biological or psychological distress beyond the acute challenge period, and physiological effects return to baseline within 90 min. In fact, the CPT is used to study pain in children, and is considered a noninvasive, exempt educational experimental activity by the IRB of the University of Texas-Austin. It has been used extensively in cardiology, endocrinology, psychiatry, and psychology since 1940 as a challenge to the peripheral and central stress axis. | Where number analyzed is less than 10, data were not collected for the number that are not reported. | Posted | Mean | Standard Deviation | pg/mL | day 0, day 7, and day 14 |
|
|
|
| Secondary | Stress as Assessed by a Visual Analog Scale (VAS) for Stress | Score provided is the total score (0 to 300) across three items that are each on a 0-100 scale. A higher score indicates greater stress. | Posted | Mean | Standard Deviation | units on a scale | day 0, day 2, day 4, day 7, day 9, day 11, and day 14 |
|
|
|
| Secondary | Percent Medication Compliance as Assessed by the Medical Event Monitoring System (MEMS, Aprex Corporation) Bottles | Posted | Mean | Standard Deviation | percent medication compliance | day 2, day 4, day 7, day 9, day 11, and day 14 |
|
|
|
| Secondary | Percent Medication Compliance as Assessed by Pill Counts | Posted | Mean | Standard Deviation | percent medication compliance | day 2, day 4, day 7, day 9, day 11, and day 14 |
|
|
|
| Secondary | Percent Medication Compliance as Assessed by Analysis of Riboflavin Markers in Urine Samples | Posted | Mean | Standard Deviation | percent medication compliance | day 2, day 4, day 7, day 9, day 11, and day 14 |
|
|
|
| Secondary | Percent Medication Compliance as Assessed by Text Reminders and Replies | Text-based reminders to take the medication will be enabled via using a HIPAA secure texting service (Talksoft ©), used broadly in medical settings. Participants will be prompted each night at 10 PM to take their medication, and instructed to text back "yes" when they have taken their medication. | Posted | Mean | Standard Deviation | percent medication compliance | day 2, day 4, day 7, day 9, day 11, and day 14 |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Placebo | Subjects will receive placebo once daily at 10 PM. Placebo (for suvorexant): Subjects will receive placebo capsules once daily at 10 PM. | 0 | 10 | 0 | 10 | 0 | 10 |
Not provided
Not provided
Not provided
| D004040 |
| Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |
| day 14 |
|
| day 2 |
|
| day 4 |
|
| day 7 |
|
|
| day 9 |
|
| day 11 |
|
| day 14 |
|
|
| day 14, immediately before CPT |
|
| day 0, immediately after CPT |
|
| day 7, immediately after CPT |
|
| day 14, immediately after CPT |
|
| day 14, immediately before CPT |
|
| day 0, immediately after CPT |
|
| day 7, immediately after CPT |
|
| day 14, immediately after CPT |
|
| day 7, immediately before CPT |
|
|
| day 14, immediately before CPT |
|
|
| day 0, immediately after CPT |
|
|
| day 7, immediately after CPT |
|
|
| day 14, immediately after CPT |
|
|
| day 4 |
|
| day 7 |
|
| day 9 |
|
| day 11 |
|
| day 14 |
|
| day 7 |
|
| day 9 |
|
| day 11 |
|
| day 14 |
|
| day 7 |
|
| day 9 |
|
| day 11 |
|
| day 14 |
|
| day 7 |
|
| day 9 |
|
| day 11 |
|
| day 14 |
|
| day 7 |
|
| day 9 |
|
| day 11 |
|
| day 14 |
|