Medical Management of Sleep Disturbance During Opioid Tapering

Johns Hopkins University

Status and phase: Completed; Phase 2

Conditions: Opioid Withdrawal; Sleep Disturbance; Opioid Dependence

Treatments: Drug: High Dose Suvorexant; Drug: Placebo oral capsule; Drug: Low Dose Suvorexant

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03789214

IRB00198426

UG3DA048734 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo sleep medication (Placebo oral capsule)

Treatment:

Drug: Placebo oral capsule

Low Dose Suvorexant

Active Comparator group

Description:

Low dose sleep medication

Treatment:

Drug: Low Dose Suvorexant

High Dose Suvorexant

Active Comparator group

Description:

High dose sleep medication

Treatment:

Drug: High Dose Suvorexant