The purpose of this study is to determine the effects of SUVO on sleep, stress, and cue reactivity/craving and to evaluate the preliminary safety and side effects profile of suvorexant (SUVO)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
7
Participants will receive 20mg of SUVO for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
Participants will receive 0mg of placebo for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Self-reported Sleep as Assessed by the PITTSBURGH SLEEP QUALITY INDEX (PSQI)
Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21, higher score indicating a worse outcome. The global PSQI score is reported.
Time frame: 7 days
Resting State Alpha Power as Assessed by EEG
EEG will be used to assess electrical activity in the brain, specifically, to assess alpha power, which is the level of activity in the 8-12Hz frequency range. Resting state EEG means that EEG will be assessed during wakeful rest. Alpha power will be assessed in each of the 4 brain lobes (frontal, central, parietal, and occipital) for 3 minutes during eyes closed wakeful rest and also for 3 minutes during eyes open wakeful rest. Alpha Power will be reported in microvolts squared (μV²). Higher alpha power indicates more sleepiness and lower alpha power indicates less sleepiness
Time frame: 7 days
Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by the EEG
The Picture Viewing Task will be used to elicit the late positive potential (LPP), reflecting the motivational salience of a stimulus. During this task, participants are asked to view a slideshow of images including pleasant, unpleasant, neutral, and Methamphetamine-related images. The amplitude of the LPP in microvolts in response to visual stimuli is reported.
Time frame: 7 days
Self-reported Stress as Assessed by the Stress Subscale of the Depression, Anxiety and Stress Scale (DASS-21)
The Stress Subscale of the Depression, Anxiety and Stress scale (DASS-21) assesses stress levels. Total score on the DASS-21 stress subscale ranges from 0 to 21, with a higher score indicating greater stress.
Time frame: 7 days
Self-reported Stress as Assessed by the Visual Analog Scale (VAS)
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The Visual Analog Scale is scored from 0-10, with 0 being no stress, 10 being extreme stress.
Time frame: 7 days
Change of Cortisol Level
During the cold pressor task (CPT), participants will submerge their dominant arm in an ice-water bath for up to 2 minutes. Saliva samples will be collected before and after the CPT, and cortisol levels in the saliva samples will be assessed. The change in cortisol level will be reported as \[(cortisol level at post cold pressor task) - (cortisol level pre cold pressor task)\].
Time frame: baseline, about 32 minutes after the start of the cold pressor task
Average Sleep Time Per Night Measured Nightly Via Actigraphy Watch Over 7 Nights
The average sleep time per night (averaged over 7 days) will be reported.
Time frame: 7 days
Average Time Awake After Sleep Onset Measured Nightly Via Actigraphy Watch Over 7 Nights
The average time awake after sleep onset per night (averaged over 7 days) will be reported.
Time frame: 7 days
Number of Days of Methamphetamine Use as Assessed by the Time Line Follow Back (TLFB) Method
Timeline Followback (TLFB) is a method to assess Methamphetamine use that involves asking study participants to self-report their Methamphetamine use over the past week.
Time frame: 7 days
Number of Participants Positive for Methamphetamine Use as Assessed by the Urine Drug Screen (UDS)
Time frame: Day 7
Number of Participants Who Had Side Effects
Time frame: 7 days
Depression as Assessed by the Beck's Depression Inventory (BDI)Scale
Beck's Depression Inventory (BDI)scale total score ranges from 0 to 63, higher score indicating more depression
Time frame: 7 days
Suicidal Ideation and Behavior as Assessed by the COLUMBIA-SUICIDE SEVERITY RATING SCALE (CSSR)
This is a semi-structured interview that measures suicide ideation on a 6-point ordinal scale, ranging from 0 (no suicide ideation) to 5 (suicidal intent with plan) with a higher score indicating worse outcome
Time frame: 7 days