Medical Management of Sleep Disturbance During Opioid Tapering
Condition: Opioid Dependence; Opioid Withdrawal; Sleep Disturbance
MeSH terms: Dyssomnias; Parasomnias; Opioid-Related Disorders
Intervention: Placebo oral capsule; Low Dose Suvorexant; High Dose Suvorexant
Intervention description: Placebo Sleep Medication; Low Dose Suvorexant; High Dose Suvorexant
Intervention MeSH terms: Suvorexant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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)