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

April 22, 2025 updated by: Heather E. Webber, PhD, The University of Texas Health Science Center, Houston
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
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.
Drug: 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.
Experimental: 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
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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
7 days
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
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
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.
7 days
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.
7 days
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.
7 days
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)].
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
Time Frame: 7 days
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
Time Frame: 7 days
The average time awake after sleep onset per night (averaged over 7 days) will be reported.
7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Days of Methamphetamine Use as Assessed by the Time Line Follow Back (TLFB) Method
Time Frame: 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.
7 days
Number of Participants Positive for Methamphetamine Use as Assessed by the Urine Drug Screen (UDS)
Time Frame: Day 7
Day 7
Number of Participants Who Had Side Effects
Time Frame: 7 days
7 days
Depression as Assessed by the Beck's Depression Inventory (BDI)Scale
Time Frame: 7 days
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)
Time Frame: 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
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heather Webber, PhD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 28, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-MS-22-0796

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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