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The purpose of this study is to determine the effects of suvorexant (SUVO), on sleep, stress, and drug craving during early abstinence from stimulants and to determine the effects of treatment (SUVO vs. treatment as usual (TAU)) on post-treatment (Days 13-30) residential program length of stay (LOS) and completion rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SUVO | Experimental |
| |
| TAU | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SUVO | Drug | Participants will receive 20mg of SUVO for 7 days in the evening before bed on Day 5 through Day 11 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in total sleep duration as assessed by the actigraphy watch | Baseline (Day 4), Day 5, day 6, day 7, day 8, day 9, day 10, day 11 | |
| Change in wake after sleep onset measured via actigraphy watch | Baseline (Day 4), Day 5, day 6, day 7, day 8, day 9, day 10, day 11 | |
| Change in self reported sleep quality as assessed by the Insomnia Severity Index (ISI) | This is a 7 item questionnaire and is rated on a five-point Likert scale ('0' representing none or not at all and '4' representing very much). Total scores range from 0 to 28, with higher combined scores indicating worse insomnia severity. | Day 5 and Day 12 |
| Changes in self reported sleep disturbance as assessed by the Patient Reported Outcomes Measurement Information System Short Form (PROMIS-SF) | This is a 4 item questionnaire and each is scored from 1-5 for a score range of 4-20, higher number indicating worse outcome | Day 5 and Day 12 |
| Changes in self reported Sleep-Related Impairment as assessed by the Patient Reported Outcomes Measurement Information System Short Form (PROMIS-SF) | This is an 8 item questionnaire and each is scored from 1-5 for a total score range of 8-40, higher number indicating worse outcome | Day 5 and Day 12 |
| Change in self-reported stress as assessed by the Visual Analog Scale (VAS) | This is measured from 0=no stress, 10=extreme stress | Day 5 and Day 12 |
| Change in stress and anxiety as assessed by the Depression, Anxiety and Stress Scale (DASS) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in resting state alpha power as assessed by EEG | Day 5 and Day 12 | |
| Change in stress as indicated by the amount of cortisol present in saliva during the cold-pressor task | Participants will submerge their hands in a bucket of ice water for up to 2 minutes and a saliva sample will be taken |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heather Webber, PhD | Contact | 713-486-2723 | Heather.E.Webber@uth.tmc.edu | |
| Jessica Vincent | Contact | 713-486-2645 | Jessica.N.Vincent@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Heather Webber, 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 | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| TAU | Drug | Participants will receive supportive care and symptomatic medication per protocol at the inpatient facility. |
|
The DASS 21 is a 21 item self report questionnaire. Each item is scored from 0 (did not apply to me at all over the last week) to 3 (applied to me very much or most of the time over the past week), higher score indicating a worse outcome |
| Day 5 and Day 12 |
| Change in craving as assessed by the self reported Stimulant Craving Questionnaire (STCQ) | This is a 10 item questionnaire, each is scored from 0 (strongly disagree) to 6 (strongly agree) for a total score range of 0-60, higher score indicating worse outcome | Day 5 and Day 12 |
| Day 5 and Day 12 |
| Change in stress as indicated by the change in heart rate during the cold-pressor task | Participants will submerge their hands in a bucket of ice water for upto 2 minutes and heart rate will be measured | Day 5 and Day 12 |
| Change in stress as indicated by the change in systolic blood pressure during the cold-pressor task for upto 2 minutes | Participants will submerge their hands in a bucket of ice water for upto 2 minutes and blood pressure will be measured | Day 5 and Day 12 |
| Change in stress as indicated by the change in diastolic blood pressure during the cold-pressor task for upto 2 minutes | Participants will submerge their hands in a bucket of ice water for upto 2 minutes and blood pressure will be measured | Day 5 and Day 12 |
| Change in the amplitude of the Reward Positivity (RewP) component in microvolts in response to feedback on the Doors Task | The Doors Task will be used to elicit the RewP component, representing reward sensitivity. The task is a guessing game, where participants guess which door contains a reward behind it. After selecting a door, the participants are notified if they found the prize by a green arrow pointing up or if they did not find the prize by a red arrow pointing down. | Day 5 and Day 12 |
| Change in intensity of demand as assessed by the Drug Purchasing Task | Demand is the maximum quantity of Methamphetamine or Cocaine consumed if the drug was free measured in grams or dollar amount | Day 5 and Day 12 |
| Length of stay (LOS) | at time of discharge (up to 30 days form baseline) |
| Percentage of participants who complete the 30 day treatment | at time of discharge (up to 30 days form baseline) |
| Change in side effects as assessed by the side effects questionnaire | This 31-item questionnaire will be administered to assess side effects and adverse events in the SUVO group only | Day 5 , Day 12 |