Methamphetamine Use DisorderPhase 2NCT05711862

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

A Phase 2 study testing suvorexant (SUVO) in people with Methamphetamine Use Disorder, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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) Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Methamphetamine Use Disorder
What is being tested?: suvorexant (SUVO)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 7 participants
Where: 1 siteUnited States
Study dates: 9 Mar 2023to 28 Mar 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Meet DSM-5 criteria for MA use disorder
Be fluent in English and able to understand the consent form

Who cannot join

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)

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Texas Health Science Center at Houston
Houston, Texas, 77030

Other trials in United States

About this study

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)

Conditions: Methamphetamine Use Disorder
Being tested: suvorexant (SUVO), Placebo
Keywords: sleeplessness, stress, Cue reactivity
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
PlaceboDrug
Participants will receive 0mg of placebo for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.

Study groups in NCT05711862
Study group	Role	What they receive
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 Receives: Drug: suvorexant (SUVO); Drug: Placebo
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 Receives: Drug: suvorexant (SUVO); Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 7 days
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.
Measured: 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)].
Measured: 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.
Measured: 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.
Measured: 7 days

Secondary outcomes (5)

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.
Measured: 7 days
Number of Participants Positive for Methamphetamine Use as Assessed by the Urine Drug Screen (UDS)
Measured: Day 7
Number of Participants Who Had Side Effects
Measured: 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
Measured: 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
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Mar 202328 Mar 2024

First posted3 Feb 2023
Study start9 Mar 2023
Primary completion28 Mar 2024
Study completion28 Mar 2024

Why it stopped: Lack of enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Methamphetamine Use DisorderStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05711862
Sponsor's protocol ID: HSC-MS-22-0796
Status last verified: Apr 2025
First submitted: 13 Jan 2023
Last updated: 29 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 39731508

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Methamphetamine Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Suvorexant on Sleep, Stress, and Cue-reactivity in Methamphetamine Use Disorder
ClinicalTrials.gov ID: NCT05711862
Acronym / sponsor ID: HSC-MS-22-0796
Conditions: Methamphetamine Use Disorder
Keywords: sleeplessness, stress, Cue reactivity
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of enrollment
Enrolment: 7 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Study start: 9 Mar 2023 (actual)
Primary completion: 28 Mar 2024 (actual)
Study completion: 28 Mar 2024 (actual)
First posted: 3 Feb 2023 (actual)
Results: Posted 29 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
1 week Placebo, then 1 week suvorexant (SUVO)	Experimental	Drug: suvorexant (SUVO), Drug: PlaceboAfter 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	Drug: suvorexant (SUVO), Drug: PlaceboAfter 1 week of SUVO treatment there will be 1 week of wash out period before start of placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Meet DSM-5 criteria for MA use disorder
Be fluent in English and able to understand the consent form

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Drug	1 week Placebo, then 1 week suvorexant (SUVO), 1 week suvorexant (SUVO), then 1 week Placebo
PlaceboParticipants will receive 0mg of placebo for 7 days. Participants will be directed to take the medication between 9:30 PM and 10:00PM.	Drug	1 week Placebo, then 1 week suvorexant (SUVO), 1 week suvorexant (SUVO), then 1 week Placebo

Primary outcome

Self-reported Sleep as Assessed by the PITTSBURGH SLEEP QUALITY INDEX (PSQI)
Time frame: 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
Time frame: 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
Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by the EEG
Time frame: 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)
Time frame: 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)
Time frame: 7 days
The Visual Analog Scale is scored from 0-10, with 0 being no stress, 10 being extreme stress.
Change of Cortisol Level
Time frame: 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
Time frame: 7 days
The average sleep time per night (averaged over 7 days) will be reported.
Average Time Awake After Sleep Onset Measured Nightly Via Actigraphy Watch Over 7 Nights
Time frame: 7 days
The average time awake after sleep onset per night (averaged over 7 days) will be reported.

5 secondary outcomes

Number of Days of Methamphetamine Use as Assessed by the Time Line Follow Back (TLFB) Method
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
Time frame: 7 days
Suicidal Ideation and Behavior as Assessed by the COLUMBIA-SUICIDE SEVERITY RATING SCALE (CSSR)
Time frame: 7 days

Results and safety

Results posted to the registry on 29 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1 Week Suvorexant (SUVO), Then 1 Week Placebo	2	2
1 Week Placebo, Then 1 Week Suvorexant (SUVO)	2	1

Primary outcome: Self-reported Sleep as Assessed by the PITTSBURGH SLEEP QUALITY INDEX (PSQI)

Time frame: 7 days. Mean (Standard Deviation). Unit: score on a scale

Measure	1 Week SUVO n = 3	1 Week Placebo n = 3
Value	8.66 (2.88)	9.66 (0.57)

Primary outcome: Resting State Alpha Power as Assessed by EEG

Time frame: 7 days. Mean (Standard Deviation). Unit: microvolts squared (μV²)

Measure	1 Week SUVO n = 3	1 Week Placebo n = 3
Eyes closed - Fz (frontal)	-1.25 (0.25)	-1.12 (0.57)
Eyes closed - Cz (Central)	-2.04 (0.52)	-1.42 (0.48)
Eyes closed - Oz (occipital)	-1.19 (0.49)	-1.12 (0.75)
Eyes closed - Pz (parietal)	-2.08 (0.27)	-1.78 (0.51)
Eyes open - Fz (frontal)	-1.46 (0.21)	-1.25 (0.27)
Eyes open - Cz (Central)	-2.16 (0.34)	-1.64 (0.44)
Eyes open - Oz (occipital)	-1.55 (0.27)	-1.44 (0.71)
Eyes open - Pz (parietal)	-2.36 (0.34)	-1.83 (0.34)

Primary outcome: Amplitude of the Late Positive Potential (LPP) in Microvolts in Response to Visual Stimuli on the Picture Viewing Task as Assessed by the EEG

Time frame: 7 days. Mean (Standard Deviation). Unit: microvolts

Measure	1 Week SUVO n = 3	1 Week Placebo n = 3
LPP Amplitude with Pleasant Images	2.85 (0.96)	1.60 (2.27)
LPP Amplitude with Unpleasant Image	1.90 (1.33)	1.38 (1.37)
LPP Amplitude with Methamphetamine Images	1.62 (0.40)	1.08 (0.27)
LPP Amplitude with Neutral Images	1.01 (0.85)	0.67 (0.56)

Primary outcome: Self-reported Stress as Assessed by the Stress Subscale of the Depression, Anxiety and Stress Scale (DASS-21)

Time frame: 7 days. Mean (Standard Deviation). Unit: score on a scale

Measure	1 Week Suvorexant (SUVO) n = 3	1 Week Placebo n = 3
Value	7.67 (6.03)	8.33 (8.50)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 3 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1 Week Suvorexant (SUVO)	0 of 4 (0%)	3 of 4 (75%)	0 of 4
1 Week Placebo	0 of 4 (0%)	3 of 4 (75%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39731508Webber 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Heather Webber, PhD principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing suvorexant (SUVO) in people with Methamphetamine Use Disorder, run by The University of Texas Health Science Center, Houston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-reported Sleep as Assessed by the PITTSBURGH SLEEP QUALITY INDEX (PSQI) (time frame: 7 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05711862, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.