Medical Management of Sleep Disturbance During Opioid Tapering

Phase 2

Completed

Conditions: Sleep Disturbance
Opioid Withdrawal
Opioid Dependence

Interventions: Drug: Placebo oral capsule
Drug: High Dose Suvorexant
Drug: Low Dose Suvorexant

Registration Number: NCT03789214

Lead Sponsor: Johns Hopkins University

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 90

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo oral capsule	Placebo sleep medication (Placebo oral capsule)
High Dose Suvorexant	High Dose Suvorexant	High dose sleep medication
Low Dose Suvorexant	Low Dose Suvorexant	Low dose sleep medication

Primary Outcome Measures

Name	Time	Method
Total Sleep Time During Buprenorphine Taper	Four nights during a buprenorphine taper	Area-under-the-curve scores of total number of minutes slept per night as measured by a 3-lead wireless electroencephalography and wrist worn actigraphy.
Subjective Opiate Withdrawal Scale During Buprenorphine Taper	Three days during a buprenorphine taper	Area-under-the-curve of peak daily scores on the Subjective Opiate Withdrawal Scale (SOWS) (a 16-item self-reported scale that measures individual opioid withdrawal symptoms using a 0-4 Likert scale; total range of SOWS is 0-64; lower scores indicate mild opioid withdrawal relative to higher scores which indicate more severe opioid withdrawal).
Total Sleep Time During Post-taper	Four nights following buprenorphine discontinuation	Area-under-the-curve scores of total number of minutes slept per night as measured by a 3-lead wireless electroencephalography and wrist worn actigraphy.
Subjective Opiate Withdrawal Scale During Post-taper	Three days following buprenorphine discontinuation	Area-under-the-curve of peak daily scores on the Subjective Opiate Withdrawal Scale (SOWS) (a 16-item self-reported scale that measures individual opioid withdrawal symptoms using a 0-4 Likert scale; total range of SOWS is 0-64; lower scores indicate mild opioid withdrawal relative to higher scores which indicate more severe opioid withdrawal).
Abuse Liability as Assessed by Visual Analogue Scale	4 nights	Area-under-the-curve of self-reported feelings of drug "High" on the morning after study drug administration, measured each morning on a 0-100 point visual analogue scale of the question "Last night, did you feel HIGH?". A score of "0" indicates no abuse liability and a score of 100 indicates extreme abuse liability. This will be assessed over four nights during an opioid taper.