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Lack of enrollment
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 week Placebo, then 1 week suvorexant (SUVO) | Experimental | After 1 week of placebo treatment there will be 1 week of wash out period before start of study medication |
|
| 1 week suvorexant (SUVO), then 1 week Placebo | Experimental | After 1 week of SUVO treatment there will be 1 week of wash out period before start of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| suvorexant (SUVO) | Drug | Participants will receive 20mg of SUVO for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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. | 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. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 days |
| Number of Participants Positive for Methamphetamine Use as Assessed by the Urine Drug Screen (UDS) |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39731508 | Derived | Webber H, Badawi J, Calvillo D, Yoon J, Weaver M, Lane S, Schmitz J. Preliminary examination of orexin receptor antagonism with suvorexant in individuals with Methamphetamine use disorder: a case series study. J Addict Dis. 2026 Jan-Mar;44(1):88-95. doi: 10.1080/10550887.2024.2434298. Epub 2024 Dec 28. |
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Of the 7 enrolled participants, 4 were randomized and 3 were lost to follow-up before randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Week Suvorexant (SUVO), Then 1 Week Placebo | After 1 week of SUVO treatment there will be 1 week of wash out period before start of placebo suvorexant (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. 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. |
| FG001 | 1 Week Placebo, Then 1 Week Suvorexant (SUVO) | After 1 week of placebo treatment there will be 1 week of wash out period before start of study medication suvorexant (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. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1 Week) |
| ||||||||||||||||
| Washout (1 Week) |
| ||||||||||||||||
| Second Intervention (1 Week) |
|
Includes all participants who were randomized and received intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 Week Suvorexant (SUVO), Then 1 Week Placebo | After 1 week of SUVO treatment there will be 1 week of wash out period before start of placebo suvorexant (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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 7 days |
|
Up to 3 weeks
Includes all participants who were randomized and received intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 Week Suvorexant (SUVO) | suvorexant (SUVO): Participants will receive 20mg of SUVO for 7 days in either the first the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowsiness | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Webber, PhD | The University of Texas Health Science Center at Houston | 713-486-2723 | Heather.E.Webber@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 9, 2023 | Mar 24, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C551624 | suvorexant |
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| Placebo | Drug | Participants will receive 0mg of placebo for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM. |
|
| Self-reported Stress as Assessed by the Visual Analog Scale (VAS) |
The Visual Analog Scale is scored from 0-10, with 0 being no stress, 10 being extreme stress. |
| 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)]. | 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. | 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. | 7 days |
| Day 7 |
| Number of Participants Who Had Side Effects | 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 | 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 | 7 days |
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG001 | 1 Week Placebo, Then 1 Week Suvorexant (SUVO) | After 1 week of placebo treatment there will be 1 week of wash out period before start of study medication suvorexant (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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Years of Education | Mean | Standard Deviation | years |
|
|
|
| Primary | 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 | Posted | Mean | Standard Deviation | microvolts squared (μV²) | 7 days |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | microvolts | 7 days |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 7 days |
|
|
|
| Primary | Self-reported Stress as Assessed by the Visual Analog Scale (VAS) | The Visual Analog Scale is scored from 0-10, with 0 being no stress, 10 being extreme stress. | Posted | Mean | Standard Deviation | score on a scale | 7 days |
|
|
|
| Primary | 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)]. | Posted | Mean | Standard Deviation | picograms per milliliter (pg/mL) | baseline, about 32 minutes after the start of the cold pressor task |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | minutes per night | 7 days |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | minutes per night | 7 days |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | days | 7 days |
|
|
|
| Secondary | Number of Participants Positive for Methamphetamine Use as Assessed by the Urine Drug Screen (UDS) | Posted | Count of Participants | Participants | Day 7 |
|
|
|
| Secondary | Number of Participants Who Had Side Effects | Posted | Count of Participants | Participants | 7 days |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | 7 days |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | 7 days |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 3 |
| 4 |
| EG001 | 1 Week Placebo | Placebo: Participants will receive 0mg of placebo for 7 days in either the first or last week of the study. Participants will be directed to take the medication between 9:30 PM and 10:00PM. | 0 | 4 | 0 | 4 | 3 | 4 |
| Not Sleeping Well | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Nervousness | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Tremor | Nervous system disorders | Systematic Assessment |
|
| Sweating | Nervous system disorders | Systematic Assessment |
|
| Cloudiness | Nervous system disorders | Systematic Assessment |
|
| Memory Loss | Nervous system disorders | Systematic Assessment |
|
| Fatigue Tiredness | Nervous system disorders | Systematic Assessment |
|
| Difficulty Walking | Nervous system disorders | Systematic Assessment |
|
| Weakness | Nervous system disorders | Systematic Assessment |
|
| Heart Racing | Nervous system disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Stomach Cramps | Gastrointestinal disorders | Systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Increased Urination | Renal and urinary disorders | Systematic Assessment |
|
| Dry Mouth | General disorders | Systematic Assessment |
|
| Fever or Chills | Immune system disorders | Systematic Assessment |
|
| Muscle Aches | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D001523 |
| Mental Disorders |
| Eyes closed - Oz (occipital) |
|
| Eyes closed - Pz (parietal) |
|
| Eyes open - Fz (frontal) |
|
| Eyes open - Cz (Central) |
|
| Eyes open - Oz (occipital) |
|
| Eyes open - Pz (parietal) |
|
| LPP Amplitude with Methamphetamine Images |
|
| LPP Amplitude with Neutral Images |
|