Orexin Receptor Antagonism and Sleep in Stimulant Use Disorder

Last updated: July 31, 2024
Sponsor: The University of Texas Health Science Center, Houston
Overall Status: Active - Recruiting

Phase

2

Condition

Stimulant Use Disorder

Treatment

TAU

SUVO

Clinical Study ID

NCT06444256
HSC-MS-24-0330
  • Ages 18-65
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Meet Diagnostic and Statistical Manual of Mental Disorders(DSM-5)criteria forprimary stimulant use disorder (either cocaine or methamphetamine)

  • Be fluent in English and able to understand the consent form

Exclusion

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 kidneydisease, 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-goingtreatment that would make participation unsafe

  • Have history of seizure disorder

  • Have a head injury with loss of consciousness in the last 5 years

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: TAU
Phase: 2
Study Start date:
July 25, 2024
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

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