Stimulant Use DisorderPhase 2NCT06444256
Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder
A Phase 2 study testing SUVO and TAU in people with Stimulant Use Disorder, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stimulant Use Disorder
- What is being tested?
- SUVO and TAU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2024to 30 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Heather Webber, PhD, 713-486-2723, Heather.E.Webber@uth.tmc.edu
Jessica Vincent, 713-486-2645, Jessica.N.Vincent@uth.tmc.edu
About this study
Official title: 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.
- Conditions
- Stimulant Use Disorder
- Being tested
- SUVO, TAU
- Keywords
- Psychostimulants, substance use, methamphetamine, cocaine
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUVODrug
Participants will receive 20mg of SUVO for 7 days in the evening before bed on Day 5 through Day 11
TAUDrug
Participants will receive supportive care and symptomatic medication per protocol at the inpatient facility.
| Study group | Role | What they receive |
|---|---|---|
| SUVO | Experimental | Not described Receives: Drug: SUVO; Drug: TAU |
| TAU | Active comparator | Not described Receives: Drug: TAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total sleep duration as assessed by the actigraphy watch
Measured: 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
Measured: 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)
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.
Measured: 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)
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
Measured: 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)
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
Measured: Day 5 and Day 12
Change in self-reported stress as assessed by the Visual Analog Scale (VAS)
This is measured from 0=no stress, 10=extreme stress
Measured: Day 5 and Day 12
Change in stress and anxiety as assessed by the Depression, Anxiety and Stress Scale (DASS)
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
Measured: Day 5 and Day 12
Change in craving as assessed by the self reported Stimulant Craving Questionnaire (STCQ)
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
Measured: Day 5 and Day 12
Secondary outcomes (10)
Change in resting state alpha power as assessed by EEG
Measured: Day 5 and Day 12
Change in stress as indicated by the amount of cortisol present in saliva during the cold-pressor task
Participants will submerge their hands in a bucket of ice water for up to 2 minutes and a saliva sample will be taken
Measured: Day 5 and Day 12
Change in stress as indicated by the change in heart rate during the cold-pressor task
Participants will submerge their hands in a bucket of ice water for upto 2 minutes and heart rate will be measured
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
Participants will submerge their hands in a bucket of ice water for upto 2 minutes and blood pressure will be measured
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
Participants will submerge their hands in a bucket of ice water for upto 2 minutes and blood pressure will be measured
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
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.
Measured: Day 5 and Day 12
Change in intensity of demand as assessed by the Drug Purchasing Task
Demand is the maximum quantity of Methamphetamine or Cocaine consumed if the drug was free measured in grams or dollar amount
Measured: Day 5 and Day 12
Length of stay (LOS)
Measured: at time of discharge (up to 30 days form baseline)
Percentage of participants who complete the 30 day treatment
Measured: at time of discharge (up to 30 days form baseline)
Change in side effects as assessed by the side effects questionnaire
This 31-item questionnaire will be administered to assess side effects and adverse events in the SUVO group only
Measured: Day 5 , Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start25 Jul 2024
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stimulant 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather E. Webber, PhD, The University of Texas Health Science Center, Houston
- Investigators
- Heather Webber, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444256
- Sponsor's protocol ID
- HSC-MS-24-0330
- Status last verified
- Sep 2025
- First submitted
- 30 May 2024
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Webber H, Tran N, Blake R, Goldman S, George T, Bailey B, Suchting R, Yoon J, Vincent J, Weaver M, Schmitz J, Lane S. The Effects of Orexin Receptor Antagonism During Early Withdrawal in Stimulant Use Disorder: Protocol for a Proof-of-Concept Study. JMIR Res Protoc. 2026 Apr 8;15:e83842. doi: 10.2196/83842.
PubMed 41950275
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder: A Pilot Study
- ClinicalTrials.gov ID
- NCT06444256
- Acronym / sponsor ID
- HSC-MS-24-0330
- Conditions
- Stimulant Use Disorder
- Keywords
- Psychostimulants, substance use, methamphetamine, cocaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SUVO | Experimental | Drug: SUVO, Drug: TAU |
| TAU | Active comparator | Drug: TAU |
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 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
Key exclusion criteria (10 listed)
- 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)
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 |
|---|---|---|
| SUVOParticipants will receive 20mg of SUVO for 7 days in the evening before bed on Day 5 through Day 11 | Drug | SUVO |
| TAUParticipants will receive supportive care and symptomatic medication per protocol at the inpatient facility. | Drug | SUVO, TAU |
Primary outcome
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
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
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.
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
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
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
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
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
10 secondary outcomes
Change in resting state alpha power as assessed by EEG
Time frame: 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
Change in stress as indicated by the change in heart rate during the cold-pressor task
Time frame: 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
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
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
Change in intensity of demand as assessed by the Drug Purchasing Task
Time frame: Day 5 and Day 12
Length of stay (LOS)
Time frame: 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)
Change in side effects as assessed by the side effects questionnaire
Time frame: Day 5 , Day 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Derived from this study: PubMed 41950275Webber H, Tran N, Blake R, Goldman S, George T, Bailey B, Suchting R, Yoon J, Vincent J, Weaver M, Schmitz J, Lane S. The Effects of Orexin Receptor Antagonism During Early Withdrawal in Stimulant Use Disorder: Protocol for a Proof-of-Concept Study. JMIR Res Protoc. 2026 Apr 8;15:e83842. doi: 10.2196/83842.
- 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.
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 SUVO and TAU in people with Stimulant 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 10 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: looking for participants now, as of the sponsor's last update on 5 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Webber, PhD (713-486-2723, Heather.E.Webber@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 NCT06444256, 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 5 Sep 2025.