RecruitingPhase 2NCT06444256

Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder

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


Sponsor

The University of Texas Health Science Center, Houston

Enrollment

20 participants

Start Date

Jul 25, 2024

Study Type

INTERVENTIONAL

Conditions

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. treatment as usual (TAU)) on post-treatment (Days 13-30) residential program length of stay (LOS) and completion rate.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria2

  • 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 Criteria10

  • 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

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Interventions

DRUGSUVO

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

DRUGTAU

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


Locations(1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

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NCT06444256


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