Examining the Role of the Orexin System in Sleep and Stress in Persons With Opioid Use Disorder

Last updated: August 26, 2024
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

2

Condition

Sleep Disorders

Stimulant Use Disorder

Opioid Use Disorder

Treatment

Placebos

Suvorexant

Clinical Study ID

NCT04287062
IRB00223942
U01HL150835
  • Ages 21-65
  • All Genders

Study Summary

This study is designed to elucidate the role of the orexin neurotransmitter system in sleep disturbance and circadian rhythms of stress that might in turn influence relapse behaviors in persons on medication-assisted treatments (MAT) who are in early recovery from opioid use disorder (OUD). Briefly, the study will enroll recently abstinent OUD patients (N=200) maintained on either extended-release naltrexone (XR-NTX), buprenorphine, or methadone. Within each MAT group, participants will be randomized to either suvorexant or placebo. The study is expected to have a 20% treatment attrition rate which will result in N=160 completers in the entire study. Patients will be recruited from and treated at Ashley Addiction Treatment, Addiction Treatment Services at Johns Hopkins Bayview Medical Center, Man Alive, or community providers.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Between the ages of 21-65, inclusive.

  • Past 30-day sleep disturbance as evidenced by a Pittsburgh Sleep Quality Index TotalScore >5.

  • Enrolled in either outpatient methadone-maintenance, buprenorphine-maintenance, orXR-NTX treatment for OUD.

  • Willingness to be maintained on a protocolized dose starting between 60-130mgmethadone or 380mg XR-NTX for the duration of the study.

  • At least two weeks of continuous abstinence from illicit opioids as evidenced byself-report and urine drug screens collected as part of routine care.

  • Willing to comply with the study protocol, which will include weekly study visits,daily actigraphy and ecological momentary assessments.

  • Use of birth control throughout study.

  • Have no clinically significant chronic medical disorders or conditions that arejudged by the investigators to prevent participation.

Exclusion

Exclusion Criteria:

  • Serious mental illnesses that are unstable and could affect study participation (thought disorders, hallucinations, delusions, thoughts of harm to self/others).

  • Current moderate to severe substance use disorder other than OUD.

  • Current illicit stimulant use, including cocaine and methamphetamine.

  • Pregnant or breast feeding.

  • Have a known allergy to the study medications.

  • Past 30-day prescribed use of suvorexant.

  • Current use of a benzodiazepine or other schedule IV medication for insomnia.

  • Use of Cytochrome P450 3A inhibitors.

  • Current narcolepsy, sleep paralysis, or restless leg syndrome as assessed by medicalhistory

  • Apnea-hypopnea index > 30.

  • Use of glucocorticoid medications and any medication that would alter thehypothalamic-pituitary-adrenal axis.

  • Past 30-day suicidal behavior as assessed by the Columbia Suicide Severity RatingScale (C-SSRS).

  • Have circumstances that would interfere with study participation (e.g., impendingjail; severe clinical issues).

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Placebos
Phase: 2
Study Start date:
November 20, 2020
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Addiction Treatment Services at Johns Hopkins Bayview Medical Center

    Baltimore, Maryland 21224
    United States

    Active - Recruiting

  • Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical Center

    Baltimore, Maryland 21224
    United States

    Active - Recruiting

  • Man Alive Inc., Lane Treatment Center

    Baltimore, Maryland 21218
    United States

    Active - Recruiting

  • Ashley Addiction Treatment

    Bel Air, Maryland 21014
    United States

    Active - Recruiting

  • Ashley Addiction Treatment

    Elkton, Maryland 21921
    United States

    Active - Recruiting

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