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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-20

Study Completion Date

2025-08-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Sleep Disturbance Opioid-use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo sleep medication (2 placebo oral capsules)

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Weight and color matched placebo

Suvorexant

Sleep medication (20mg suvorexant; 2 10mg capsules; patients can self-titrate to 1 10mg capsule)

Group Type ACTIVE_COMPARATOR

Suvorexant

Intervention Type DRUG

Dual orexin receptor antagonist

Interventions

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Suvorexant

Dual orexin receptor antagonist

Intervention Type DRUG

Placebos

Weight and color matched placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 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 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).

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No