Medical Management of Sleep Disturbance During Opioid Tapering

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2021-06-10

Brief Summary

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This study will evaluate whether a dual orexin-receptor antagonist approved by the FDA for sleep disturbance, suvorexant (SUVO; Belsomra), will increase total sleep time in patients with opioid use disorder (OUD) undergoing supervised withdrawal. This study is designed as a dose-finding study of SUVO compared to placebo. Briefly, OUD patients seeking supervised withdrawal will be admitted into a clinical research unit and stabilized onto buprenorphine for three days before being randomly assigned to study condition. All participants will then undergo a routine four-day buprenorphine taper, followed by a four-day post-taper phase. Participants will be randomized to receive either placebo, Low Dose SUVO, or High Dose SUVO and the investigators hypothesize that one or both doses of SUVO will improve total sleep time relative to placebo. Patients will attend a single follow-up session, 5-10 days following discharge.

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Detailed Description

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Conditions

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Opioid Dependence Opioid Withdrawal Sleep Disturbance

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 (Placebo oral capsule)

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

Placebo Sleep Medication

Low Dose Suvorexant

Low dose sleep medication

Group Type ACTIVE_COMPARATOR

Low Dose Suvorexant

Intervention Type DRUG

Low Dose Suvorexant

High Dose Suvorexant

High dose sleep medication

Group Type ACTIVE_COMPARATOR

High Dose Suvorexant

Intervention Type DRUG

High Dose Suvorexant

Interventions

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Placebo oral capsule

Placebo Sleep Medication

Intervention Type DRUG

Low Dose Suvorexant

Intervention Type DRUG

High Dose Suvorexant

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged 18 years old and above
* Meets Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for OUD with evidence of physical dependence on opioids, and seeking treatment to stop using illicit opioids.
* Provides a urine sample that tests positive for opioids.
* Willing to comply with the study protocol.
* Have no clinically significant chronic medical or surgical disorders or conditions that are judged by the investigators to prevent participation.

Exclusion Criteria

* Seeking or currently enrolled in methadone or buprenorphine maintenance treatment for OUD
* Pregnant or breast feeding
* Have evidence of physical dependence on alcohol or benzodiazepines that requires medical detoxification
* Have a known allergy to the study medications
* Past 30-day prescribed use of suvorexant or benzodiazepines for the indication of insomnia
* Current use of a Selective Serotonin Reuptake Inhibitor (SSRI) or Monoamine oxidase (MAO) inhibitor for depression or insomnia, or other medications that are contraindicated with suvorexant
* Current narcolepsy, restless leg syndrome or sleep paralysis
* High risk for current sleep apnea
* Current major depressive disorder
* Past year suicidal behavior
* Severe hepatic or renal impairment

* Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \>3x ULN
* Total bilirubin \>2x Upper Limit of Normal (ULN)
* Creatinine \>1.5x ULN
* Have circumstances that would interfere with study participation (e.g., impending jail)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No