NCT02785406|CompletedPhase 2ResultsDMC
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Sponsor study identifier
interventional
20
1 country
1
Study Start
May 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 15, 2018
Actual (reported)Study Completion
November 15, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 15, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2016
Date type not reportedThis date has not been verified as actual or estimated.
May 19, 2016
Actual (reported)May 27, 2016
Actual (reported)November 15, 2018
Actual (reported)November 15, 2018
Actual (reported)December 11, 2019
Actual (reported)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
Subjects will receive suvorexant (10 mg week 1, 20 mg week 2), once daily at 10 PM.
Subjects will receive placebo once daily at 10 PM.
Subjects will receive suvorexant capsules (10 mg week 1, 20 mg week 2), once daily at 10 PM.
Subjects will receive placebo capsules once daily at 10 PM.
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Scott D. Lane, PhD
The University of Texas Health Science Center, Houston
20 participants (actual enrollment reported by the registry).
First Submitted
May 19, 2016
First Posted
May 27, 2016
Study Start
May 2016
Date type not reportedThis date has not been verified as actual or estimated.
Medical Management of Sleep Disturbance During Opioid Tapering
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.
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
Cue Reactivity as Assessed by the Cocaine Craving Questionnaire (CCQ) Brief
day 0, day 7, and day 14
Sleep Quality as by the Pittsburg Sleep Quality Index (PSQI)
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
day 0, day 7, and day 14
Stress/Anxiety as Assessed by Blood Pressure During the Cold Pressor Test (CPT) - Diastolic Blood Pressure
day 0, day 7, and day 14
Stress/Anxiety as Assessed by Cortisol Level During the Cold Pressor Test (CPT)
day 0, day 7, and day 14
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 15, 2018
Actual (reported)Study Completion
November 15, 2018
Actual (reported)Last Updated
December 11, 2019
Results First Posted
December 11, 2019
Record last verified: 2019-12
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Source: ClinicalTrials.gov.
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