Methamphetamine Use Disorder
Conditions
Keywords
sleeplessness, stress, Cue reactivity
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)
Interventions
DRUGsuvorexant (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.
DRUGPlacebo
Participants will receive 0mg of placebo for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Time Awake After Sleep Onset Measured Nightly Via Actigraphy Watch Over 7 Nights | 7 days | The average time awake after sleep onset per night (averaged over 7 days) will be reported. |
| Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by the EEG | 7 days | 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. |
| Self-reported Stress as Assessed by the Stress Subscale of the Depression, Anxiety and Stress Scale (DASS-21) | 7 days | 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. |
| Self-reported Stress as Assessed by the Visual Analog Scale (VAS) | 7 days | The Visual Analog Scale is scored from 0-10, with 0 being no stress, 10 being extreme stress. |
| Change of Cortisol Level | baseline, about 32 minutes after the start of the cold pressor task | 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 \[(cortisol level at post cold pressor task) - (cortisol level pre cold pressor task)\]. |
| Average Sleep Time Per Night Measured Nightly Via Actigraphy Watch Over 7 Nights | 7 days | The average sleep time per night (averaged over 7 days) will be reported. |
| Self-reported Sleep as Assessed by the PITTSBURGH SLEEP QUALITY INDEX (PSQI) | 7 days | 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. |
| Resting State Alpha Power as Assessed by EEG | 7 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Positive for Methamphetamine Use as Assessed by the Urine Drug Screen (UDS) | Day 7 | — |
| Number of Participants Who Had Side Effects | 7 days | — |
| Depression as Assessed by the Beck's Depression Inventory (BDI)Scale | 7 days | Beck's Depression Inventory (BDI)scale total score ranges from 0 to 63, higher score indicating more depression |
| Suicidal Ideation and Behavior as Assessed by the COLUMBIA-SUICIDE SEVERITY RATING SCALE (CSSR) | 7 days | 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 |
| Number of Days of Methamphetamine Use as Assessed by the Time Line Follow Back (TLFB) Method | 7 days | 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. |
Countries
United States
Participant flow
Pre-assignment details
Of the 7 enrolled participants, 4 were randomized and 3 were lost to follow-up before randomization.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| 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. | 2 |
| Total | 4 |
Baseline characteristics
| Characteristic | 1 Week Suvorexant (SUVO), Then 1 Week Placebo | Total | 1 Week Placebo, Then 1 Week Suvorexant (SUVO) |
|---|---|---|---|
| Age, Continuous | 46.5 years STANDARD_DEVIATION 5 | 42.5 years STANDARD_DEVIATION 5.8 | 38.5 years STANDARD_DEVIATION 3.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 4 Participants | 2 Participants |
| Region of Enrollment United States | 2 participants | 4 participants | 2 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 1 Participants |
| Years of Education | 12 years STANDARD_DEVIATION 1.4 | 12.5 years STANDARD_DEVIATION 1 | 13 years STANDARD_DEVIATION 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 3 / 4 | 3 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
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.
Time frame: 7 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1 Week SUVO | Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by the EEG | LPP Amplitude with Pleasant Images | 2.85 microvolts | Standard Deviation 0.96 |
| 1 Week SUVO | Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by the EEG | LPP Amplitude with Unpleasant Image | 1.90 microvolts | Standard Deviation 1.33 |
| 1 Week SUVO | Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by the EEG | LPP Amplitude with Methamphetamine Images | 1.62 microvolts | Standard Deviation 0.4 |
| 1 Week SUVO | Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by the EEG | LPP Amplitude with Neutral Images | 1.01 microvolts | Standard Deviation 0.85 |
| 1 Week Placebo | Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by the EEG | LPP Amplitude with Neutral Images | 0.67 microvolts | Standard Deviation 0.56 |
| 1 Week Placebo | Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by the EEG | LPP Amplitude with Pleasant Images | 1.60 microvolts | Standard Deviation 2.27 |
| 1 Week Placebo | Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by the EEG | LPP Amplitude with Methamphetamine Images | 1.08 microvolts | Standard Deviation 0.27 |
| 1 Week Placebo | Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by the EEG | LPP Amplitude with Unpleasant Image | 1.38 microvolts | Standard Deviation 1.37 |
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.
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 Week SUVO | Average Sleep Time Per Night Measured Nightly Via Actigraphy Watch Over 7 Nights | 326.52 minutes per night | Standard Deviation 113.9 |
| 1 Week Placebo | Average Sleep Time Per Night Measured Nightly Via Actigraphy Watch Over 7 Nights | 303.14 minutes per night | Standard Deviation 89.44 |
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.
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 Week SUVO | Average Time Awake After Sleep Onset Measured Nightly Via Actigraphy Watch Over 7 Nights | 54.07 minutes per night | Standard Deviation 20.13 |
| 1 Week Placebo | Average Time Awake After Sleep Onset Measured Nightly Via Actigraphy Watch Over 7 Nights | 44.89 minutes per night | Standard Deviation 15.16 |
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 \[(cortisol level at post cold pressor task) - (cortisol level pre cold pressor task)\].
Time frame: baseline, about 32 minutes after the start of the cold pressor task
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 Week SUVO | Change of Cortisol Level | 2103.99 picograms per milliliter (pg/mL) | Standard Deviation 4226.09 |
| 1 Week Placebo | Change of Cortisol Level | 233.55 picograms per milliliter (pg/mL) | Standard Deviation 1225.26 |
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
Time frame: 7 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 1 Week SUVO | Resting State Alpha Power as Assessed by EEG | Eyes closed - Fz (frontal) | -1.25 microvolts squared (μV²) | Standard Deviation 0.25 |
| 1 Week SUVO | Resting State Alpha Power as Assessed by EEG | Eyes closed - Cz (Central) | -2.04 microvolts squared (μV²) | Standard Deviation 0.52 |
| 1 Week SUVO | Resting State Alpha Power as Assessed by EEG | Eyes closed - Oz (occipital) | -1.19 microvolts squared (μV²) | Standard Deviation 0.49 |
| 1 Week SUVO | Resting State Alpha Power as Assessed by EEG | Eyes closed - Pz (parietal) | -2.08 microvolts squared (μV²) | Standard Deviation 0.27 |
| 1 Week SUVO | Resting State Alpha Power as Assessed by EEG | Eyes open - Fz (frontal) | -1.46 microvolts squared (μV²) | Standard Deviation 0.21 |
| 1 Week SUVO | Resting State Alpha Power as Assessed by EEG | Eyes open - Cz (Central) | -2.16 microvolts squared (μV²) | Standard Deviation 0.34 |
| 1 Week SUVO | Resting State Alpha Power as Assessed by EEG | Eyes open - Oz (occipital) | -1.55 microvolts squared (μV²) | Standard Deviation 0.27 |
| 1 Week SUVO | Resting State Alpha Power as Assessed by EEG | Eyes open - Pz (parietal) | -2.36 microvolts squared (μV²) | Standard Deviation 0.34 |
| 1 Week Placebo | Resting State Alpha Power as Assessed by EEG | Eyes open - Pz (parietal) | -1.83 microvolts squared (μV²) | Standard Deviation 0.34 |
| 1 Week Placebo | Resting State Alpha Power as Assessed by EEG | Eyes closed - Fz (frontal) | -1.12 microvolts squared (μV²) | Standard Deviation 0.57 |
| 1 Week Placebo | Resting State Alpha Power as Assessed by EEG | Eyes open - Fz (frontal) | -1.25 microvolts squared (μV²) | Standard Deviation 0.27 |
| 1 Week Placebo | Resting State Alpha Power as Assessed by EEG | Eyes closed - Cz (Central) | -1.42 microvolts squared (μV²) | Standard Deviation 0.48 |
| 1 Week Placebo | Resting State Alpha Power as Assessed by EEG | Eyes open - Oz (occipital) | -1.44 microvolts squared (μV²) | Standard Deviation 0.71 |
| 1 Week Placebo | Resting State Alpha Power as Assessed by EEG | Eyes closed - Oz (occipital) | -1.12 microvolts squared (μV²) | Standard Deviation 0.75 |
| 1 Week Placebo | Resting State Alpha Power as Assessed by EEG | Eyes open - Cz (Central) | -1.64 microvolts squared (μV²) | Standard Deviation 0.44 |
| 1 Week Placebo | Resting State Alpha Power as Assessed by EEG | Eyes closed - Pz (parietal) | -1.78 microvolts squared (μV²) | Standard Deviation 0.51 |
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.
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 Week SUVO | Self-reported Sleep as Assessed by the PITTSBURGH SLEEP QUALITY INDEX (PSQI) | 8.66 score on a scale | Standard Deviation 2.88 |
| 1 Week Placebo | Self-reported Sleep as Assessed by the PITTSBURGH SLEEP QUALITY INDEX (PSQI) | 9.66 score on a scale | Standard Deviation 0.57 |
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.
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 Week SUVO | Self-reported Stress as Assessed by the Stress Subscale of the Depression, Anxiety and Stress Scale (DASS-21) | 7.67 score on a scale | Standard Deviation 6.03 |
| 1 Week Placebo | Self-reported Stress as Assessed by the Stress Subscale of the Depression, Anxiety and Stress Scale (DASS-21) | 8.33 score on a scale | Standard Deviation 8.5 |
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.
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 Week SUVO | Self-reported Stress as Assessed by the Visual Analog Scale (VAS) | 2.33 score on a scale | Standard Deviation 3.21 |
| 1 Week Placebo | Self-reported Stress as Assessed by the Visual Analog Scale (VAS) | 5.67 score on a scale | Standard Deviation 5.13 |
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
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 Week SUVO | Depression as Assessed by the Beck's Depression Inventory (BDI)Scale | 9.33 score on a scale | Standard Deviation 3.06 |
| 1 Week Placebo | Depression as Assessed by the Beck's Depression Inventory (BDI)Scale | 25.00 score on a scale | Standard Deviation 27.18 |
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.
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 Week SUVO | Number of Days of Methamphetamine Use as Assessed by the Time Line Follow Back (TLFB) Method | 2.67 days | Standard Deviation 2.52 |
| 1 Week Placebo | Number of Days of Methamphetamine Use as Assessed by the Time Line Follow Back (TLFB) Method | 3.33 days | Standard Deviation 2.89 |
Secondary
Number of Participants Positive for Methamphetamine Use as Assessed by the Urine Drug Screen (UDS)
Time frame: Day 7
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1 Week SUVO | Number of Participants Positive for Methamphetamine Use as Assessed by the Urine Drug Screen (UDS) | 2 Participants |
| 1 Week Placebo | Number of Participants Positive for Methamphetamine Use as Assessed by the Urine Drug Screen (UDS) | 0 Participants |
Secondary
Number of Participants Who Had Side Effects
Time frame: 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1 Week SUVO | Number of Participants Who Had Side Effects | 3 Participants |
| 1 Week Placebo | Number of Participants Who Had Side Effects | 3 Participants |
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
Time frame: 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 Week SUVO | Suicidal Ideation and Behavior as Assessed by the COLUMBIA-SUICIDE SEVERITY RATING SCALE (CSSR) | 0 score on a scale | Standard Deviation 0 |
| 1 Week Placebo | Suicidal Ideation and Behavior as Assessed by the COLUMBIA-SUICIDE SEVERITY RATING SCALE (CSSR) | 0 score on a scale | Standard Deviation 0 |