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NCT Number: NCT06444256

Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder

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.

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Key information

Conditions

Stimulant Use Disorder Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SUVO

Drug

Participants will receive 20mg of SUVO for 7 days in the evening before bed on Day 5 through Day 11

TAU

Drug

Participants will receive supportive care and symptomatic medication per protocol at the inpatient facility.

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Secondary outcomes

  1. Change in resting state alpha power as assessed by EEG

    Time frame: Day 5 and Day 12

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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

  8. Length of stay (LOS)

    Time frame: at time of discharge (up to 30 days form baseline)

  9. Percentage of participants who complete the 30 day treatment

    Time frame: at time of discharge (up to 30 days form baseline)

  10. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Heather Webber, PhD

CONTACT

[email protected]

713-486-2723

Jessica Vincent

CONTACT

[email protected]

713-486-2645

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2024
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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