The Effects of Suvorexant on Sleep, Stress, and Cue-reactivity in Methamphetamine Use Disorder

Study Overview
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Brief Summary
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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)

Official Title
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The Effects of Suvorexant on Sleep, Stress, and Cue-reactivity in Methamphetamine Use Disorder

Conditions
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Methamphetamine Use Disorder

Intervention / Treatment
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* Drug: SUVO
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet DSM-5 criteria for MA use disorder Be fluent in English and able to understand the consent form Exclusion Criteria: Have an alcohol use disorder or report binge drinking (>7 drinks for women and >14 drinks for men) Have a greater than mild substance use disorder on any other illicit 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) Are currently taking medications with known drug interactions with SUVO (e.g., MAO inhibitors, anticonvulsants, haloperidol, phenothiazines, anesthetics, and any sedative) Are pregnant or breast feeding BMI > 30 (women only) Have a current DSM-5 psychiatric disorder or neurological disease requiring on-going treatment that would make participation unsafe Have history of seizure disorder Have a head injury with loss of consciousness in the last 5 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 week Placebo then 1 week SUVO<br>After 1 week of placebo treatment there will be 1 week of wash out period before start of study medication | Drug: SUVO<br>* Participants will receive 20mg of SUVO for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.<br>Drug: Placebo<br>* Participants will receive 0mg of placebo for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.<br>|
| Experimental: 1 week SUVO then 1 week Placebo<br>After 1 week of SUVO treatment there will be 1 week of wash out period before start of placebo | Drug: SUVO<br>* Participants will receive 20mg of SUVO for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.<br>Drug: Placebo<br>* Participants will receive 0mg of placebo for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-reported sleep as assessed by the PITTSBURGH SLEEP QUALITY INDEX (PSQI) | This is an 18 item questionnaire, each is scored from 0(no difficulty) to 3 (severe difficulty) a higher number indicating worse sleep | After 7 days of treatment with SUVO, after 7 days of washout, after 7 days of treatment with placebo | 
| Change in resting state alpha power as assessed by EEG |  | After 7 days of treatment with SUVO, after 7 days of washout, after 7 days of treatment with placebo | 
| Change in the 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 LPP, reflecting the motivational salience of a stimulus. In the task, the participants view images in four categories, pleasant, unpleasant, methamphetamine, and neutral. | After 7 days of treatment with SUVO, after 7 days of washout, after 7 days of treatment with placebo | 
| Change in self-reported stress as assessed by the Depression, anxiety and Stress scale (DASS-21) | This is a 21 item questionnaire and each is scored from 0(did not apply to me at all) to 3 (apply to me very much or most of the time), higher score indicating a worse outcome | After 7 days of treatment with SUVO, after 7 days of washout, after 7 days of treatment with placebo | 
| Change in self-reported stress as assessed by the Visual Analog Scale (VAS) | This is measured from 0=no stress, 10=extreme stress | After 7 days of treatment with SUVO, after 7 days of washout, after 7 days of treatment with placebo | 
| Change in amount of cortisol measured | This is measured before and after the cold pressor task and measures the amount of cortisol in saliva | After 7 days of treatment with SUVO, after 7 days of washout, after 7 days of treatment with placebo | 
| Change in total sleep time measured nightly via actigraphy watch |  | Nightly for 3 weeks | 
| Change in wake after sleep onset measured nightly via actigraphy watch |  | Nightly for 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of days of Methamphetamine use as assessed by the time line follow back (TLFB) method |  | After 7 days of treatment with SUVO, after 7 days of washout, after 7 days of treatment with placebo | 
| Change in number of days of methamphetamine use as assessed by the urine drug screen (UDS) |  | After 7 days of treatment with SUVO, after 7 days of washout, after 7 days of treatment with placebo | 
| Change in side effects as assessed by the side effects questionnaire | 31 symptoms are rated using the following scale: None, Mild, Moderate, Severe | After 7 days of treatment with SUVO, after 7 days of washout, after 7 days of treatment with placebo | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleeplessness, stress, Cue reactivity