About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Meet Diagnostic and Statistical Manual of Mental Disorders(DSM-5)criteria for primary stimulant use disorder (either cocaine or methamphetamine)
Be fluent in English and able to understand the consent form
Disqualifiers
Have an opioid use disorder of any severity
Have a greater than moderate substance use disorder on any other substance
Undergoing medication-assisted treatment for withdrawal of any substance
Have any medical conditions contraindicating SUVO (e.g., severe pulmonary disease, severe cardiovascular disease or clinically abnormal ECG, severe liver or kidney disease, seizure disorder, or sleep disorder -particularly narcolepsy)
Trial design
Parallel
Treatments tested in this trial
SUVO
DrugParticipants will receive 20mg of SUVO for 7 days in the evening before bed on Day 5 through Day 11
TAU
DrugParticipants will receive supportive care and symptomatic medication per protocol at the inpatient facility.
Treatment groups
Trial outcomes
Primary outcomes
Change in total sleep duration as assessed by the actigraphy watch
Change in wake after sleep onset measured via actigraphy watch
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.
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
Secondary outcomes
Change in resting state alpha power as assessed by EEG
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
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
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
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