Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder

September 3, 2025 updated by: Heather E. Webber, PhD, The University of Texas Health Science Center, Houston

Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder: A Pilot Study

The purpose of this study is to determine the effects of suvorexant (SUVO), on sleep, stress, and drug craving during early abstinence from stimulants and to determine the effects of treatment (SUVO vs. treatment as usual (TAU)) on post-treatment (Days 13-30) residential program length of stay (LOS) and completion rate.

Study Overview

Status

Status

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

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 (Estimated)

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.
20

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Meet Diagnostic and Statistical Manual of Mental Disorders(DSM-5)criteria for primary stimulant use disorder (either cocaine or methamphetamine)
  • Be fluent in English and able to understand the consent form

Exclusion Criteria:

  • Have an opioid use disorder of any severity
  • Have a greater than moderate substance use disorder on any other substance
  • Undergoing medication-assisted treatment for withdrawal of any 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., Monoamine oxidase (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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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.
Active Comparator: TAU
Drug: TAU
Participants will receive supportive care and symptomatic medication per protocol at the inpatient facility.
Experimental: SUVO
Drug: SUVO
Participants will receive 20mg of SUVO for 7 days in the evening before bed on Day 5 through Day 11
Drug: TAU
Participants will receive supportive care and symptomatic medication per protocol at the inpatient facility.

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
Change in total sleep duration as assessed by the actigraphy watch
Time Frame: Baseline (Day 4), Day 5, day 6, day 7, day 8, day 9, day 10, day 11
Baseline (Day 4), Day 5, day 6, day 7, day 8, day 9, day 10, day 11
Change in wake after sleep onset measured via actigraphy watch
Time Frame: Baseline (Day 4), Day 5, day 6, day 7, day 8, day 9, day 10, day 11
Baseline (Day 4), Day 5, day 6, day 7, day 8, day 9, day 10, day 11
Change in self reported sleep quality as assessed by the Insomnia Severity Index (ISI)
Time Frame: Day 5 and Day 12
This is a 7 item questionnaire and is rated on a five-point Likert scale ('0' representing none or not at all and '4' representing very much). Total scores range from 0 to 28, with higher combined scores indicating worse insomnia severity.
Day 5 and Day 12
Changes in self reported sleep disturbance as assessed by the Patient Reported Outcomes Measurement Information System Short Form (PROMIS-SF)
Time Frame: Day 5 and Day 12
This is a 4 item questionnaire and each is scored from 1-5 for a score range of 4-20, higher number indicating worse outcome
Day 5 and Day 12
Changes in self reported Sleep-Related Impairment as assessed by the Patient Reported Outcomes Measurement Information System Short Form (PROMIS-SF)
Time Frame: Day 5 and Day 12
This is an 8 item questionnaire and each is scored from 1-5 for a total score range of 8-40, higher number indicating worse outcome
Day 5 and Day 12
Change in self-reported stress as assessed by the Visual Analog Scale (VAS)
Time Frame: Day 5 and Day 12
This is measured from 0=no stress, 10=extreme stress
Day 5 and Day 12
Change in stress and anxiety as assessed by the Depression, Anxiety and Stress Scale (DASS)
Time Frame: Day 5 and Day 12
The DASS 21 is a 21 item self report questionnaire. Each item is scored from 0 (did not apply to me at all over the last week) to 3 (applied to me very much or most of the time over the past week), higher score indicating a worse outcome
Day 5 and Day 12
Change in craving as assessed by the self reported Stimulant Craving Questionnaire (STCQ)
Time Frame: Day 5 and Day 12
This is a 10 item questionnaire, each is scored from 0 (strongly disagree) to 6 (strongly agree) for a total score range of 0-60, higher score indicating worse outcome
Day 5 and Day 12

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
Change in resting state alpha power as assessed by EEG
Time Frame: Day 5 and Day 12
Day 5 and Day 12
Change in stress as indicated by the amount of cortisol present in saliva during the cold-pressor task
Time Frame: Day 5 and Day 12
Participants will submerge their hands in a bucket of ice water for up to 2 minutes and a saliva sample will be taken
Day 5 and Day 12
Change in stress as indicated by the change in heart rate during the cold-pressor task
Time Frame: Day 5 and Day 12
Participants will submerge their hands in a bucket of ice water for upto 2 minutes and heart rate will be measured
Day 5 and Day 12
Change in stress as indicated by the change in systolic blood pressure during the cold-pressor task for upto 2 minutes
Time Frame: Day 5 and Day 12
Participants will submerge their hands in a bucket of ice water for upto 2 minutes and blood pressure will be measured
Day 5 and Day 12
Change in stress as indicated by the change in diastolic blood pressure during the cold-pressor task for upto 2 minutes
Time Frame: Day 5 and Day 12
Participants will submerge their hands in a bucket of ice water for upto 2 minutes and blood pressure will be measured
Day 5 and Day 12
Change in the amplitude of the Reward Positivity (RewP) component in microvolts in response to feedback on the Doors Task
Time Frame: Day 5 and Day 12
The Doors Task will be used to elicit the RewP component, representing reward sensitivity. The task is a guessing game, where participants guess which door contains a reward behind it. After selecting a door, the participants are notified if they found the prize by a green arrow pointing up or if they did not find the prize by a red arrow pointing down.
Day 5 and Day 12
Change in intensity of demand as assessed by the Drug Purchasing Task
Time Frame: Day 5 and Day 12
Demand is the maximum quantity of Methamphetamine or Cocaine consumed if the drug was free measured in grams or dollar amount
Day 5 and Day 12
Length of stay (LOS)
Time Frame: at time of discharge (up to 30 days form baseline)
at time of discharge (up to 30 days form baseline)
Percentage of participants who complete the 30 day treatment
Time Frame: at time of discharge (up to 30 days form baseline)
at time of discharge (up to 30 days form baseline)
Change in side effects as assessed by the side effects questionnaire
Time Frame: Day 5 , Day 12
This 31-item questionnaire will be administered to assess side effects and adverse events in the SUVO group only
Day 5 , Day 12

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.
July 25, 2024

Primary Completion (Estimated)

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.
January 30, 2027

Study Completion (Estimated)

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.
January 30, 2027

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).
May 30, 2024

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.
May 30, 2024

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.
June 5, 2024

Study Record Updates

Last Update Posted (Estimated)

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.
September 5, 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.
September 3, 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.
September 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-24-0330

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

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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