The Effects of Suvorexant on Sleep, Stress, and Cue-reactivity in Methamphetamine Use Disorder
Study Details
Study Description
Brief Summary
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 week Placebo then 1 week SUVO After 1 week of placebo treatment there will be 1 week of wash out period before start of study medication |
Drug: SUVO
Participants will receive 20mg of SUVO for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
Drug: Placebo
Participants will receive 0mg of placebo for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
|
| Experimental: 1 week SUVO then 1 week Placebo After 1 week of SUVO treatment there will be 1 week of wash out period before start of placebo |
Drug: SUVO
Participants will receive 20mg of SUVO for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
Drug: Placebo
Participants will receive 0mg of placebo for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
|
Outcome Measures
Primary Outcome Measures
- Change in self-reported sleep as assessed by the PITTSBURGH SLEEP QUALITY INDEX (PSQI) [After 7 days of treatment with SUVO, after 7 days of washout, after 7 days of treatment with placebo]
This is an 18 item questionnaire, each is scored from 0(no difficulty) to 3 (severe difficulty) a higher number indicating worse sleep
- 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 [After 7 days of treatment with SUVO, after 7 days of washout, after 7 days of treatment with placebo]
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.
- Change in self-reported stress as assessed by the Depression, anxiety and Stress scale (DASS-21) [After 7 days of treatment with SUVO, after 7 days of washout, after 7 days of treatment with placebo]
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
- Change in self-reported stress as assessed by the Visual Analog Scale (VAS) [After 7 days of treatment with SUVO, after 7 days of washout, after 7 days of treatment with placebo]
This is measured from 0=no stress, 10=extreme stress
- Change in amount of cortisol measured [After 7 days of treatment with SUVO, after 7 days of washout, after 7 days of treatment with placebo]
This is measured before and after the cold pressor task and measures the amount of cortisol in saliva
- 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
- 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 [After 7 days of treatment with SUVO, after 7 days of washout, after 7 days of treatment with placebo]
31 symptoms are rated using the following scale: None, Mild, Moderate, Severe
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Meet DSM-5 criteria for MA use disorder
-
Be fluent in English and able to understand the consent form
Exclusion Criteria:
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Have an alcohol use disorder or report binge drinking (>7 drinks for women and >14 drinks for men)
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Have a greater than mild substance use disorder on any other illicit substance
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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)
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Are currently taking medications with known drug interactions with SUVO (e.g., MAO inhibitors, anticonvulsants, haloperidol, phenothiazines, anesthetics, and any sedative)
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Are pregnant or breast feeding
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BMI > 30 (women only)
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Have a current DSM-5 psychiatric disorder or neurological disease requiring on-going treatment that would make participation unsafe
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Have history of seizure disorder
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Have a head injury with loss of consciousness in the last 5 years
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- The University of Texas Health Science Center, Houston
Investigators
- Principal Investigator: Heather Webber, PhD, The University of Texas Health Science Center, Houston
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSC-MS-22-0796