Status:
COMPLETED
Examining the Role of the Orexin System in Sleep and Stress in Persons With Opioid Use Disorder
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sleep Disturbance
Opioid-use Disorder
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
Brief 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 med...
Eligibility Criteria
Inclusion
- Between the ages of 21-65, inclusive.
- Past 30-day sleep disturbance as evidenced by a Pittsburgh Sleep Quality Index Total Score \>5.
- Enrolled in either outpatient methadone-maintenance, buprenorphine-maintenance, or XR-NTX treatment for OUD.
- Willingness to be maintained on a protocolized dose starting between 60-130mg methadone or 380mg XR-NTX for the duration of the study.
- At least two weeks of continuous abstinence from illicit opioids as evidenced by self-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 are judged by the investigators to prevent participation.
Exclusion
- 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 medical history
- Apnea-hypopnea index \> 30.
- Use of glucocorticoid medications and any medication that would alter the hypothalamic-pituitary-adrenal axis.
- Past 30-day suicidal behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).
- Have circumstances that would interfere with study participation (e.g., impending jail; severe clinical issues).
Key Trial Info
Start Date :
November 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2025
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT04287062
Start Date
November 20 2020
End Date
August 15 2025
Last Update
November 20 2025
Active Locations (5)
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1
Man Alive Inc., Lane Treatment Center
Baltimore, Maryland, United States, 21218
2
Addiction Treatment Services at Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
3
Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
4
Ashley Addiction Treatment
Bel Air, Maryland, United States, 21014