Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder

This study is investigating how suvorexant (SUVO), a medication, affects sleep, stress, and drug cravings in people who are in early recovery from stimulant use disorder (cocaine or methamphetamine). Researchers also want to see if SUVO impacts how long participants stay in a residential treatment program and their completion rates. You might be able to join if you are between 18 and 65 years old, speak English, and have a stimulant use disorder. The study aims to measure changes in your total sleep duration and how often you wake up after falling asleep, both tracked by a watch. It will also assess your self-reported sleep quality. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 20 participants. It compares the effects of suvorexant (SUVO) to standard care (TAU).
What's involved
Participants will receive SUVO for 7 days, taken in the evening before bed, from Day 5 through Day 11. Sleep will be assessed using an actigraphy watch and self-reported questionnaires at various points between Day 4 and Day 12.
Compensation
Not stated in the trial record.
Follow-up
The study will assess residential program length of stay and completion rates for 13-30 days after treatment.

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NCT06444256

Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder

Recruiting
PHASE2Ages 18–65InterventionalTreatment
The University of Texas Health Science Center, Houston
~20 participants
Updated 2025-09-05 on ClinicalTrials.gov
What's tested:SUVOTAU

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in total sleep duration as assessed by the actigraphy watch
Measured over Baseline (Day 4), Day 5, day 6, day 7, day 8, day 9, day 10, day 11
+7 more outcomes measured
Stimulant Use Disorder
1 sites across 1 states
Texas1
  • Heather Webber, PhD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

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Eligibility criteria

Inclusion

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

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
  • Change in total sleep duration as assessed by the actigraphy watchBaseline (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 watchBaseline (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)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)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)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)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)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)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