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OpenTrials
Completed

NCT Number: NCT03789214

Medical Management of Sleep Disturbance During Opioid Tapering

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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Key information

Conditions

Opioid Dependence Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Nervous System Diseases Opioid Withdrawal Opioid-Related Disorders Parasomnias Sleep Disturbance Sleep Wake Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Placebo oral capsule

Drug

Placebo Sleep Medication

Low Dose Suvorexant

Drug

Low Dose Suvorexant

High Dose Suvorexant

Drug

High Dose Suvorexant

Primary outcomes

  1. Abuse Liability as Assessed by Visual Analogue Scale

    Time frame: 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.

  2. Total Sleep Time During Buprenorphine Taper

    Time frame: 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.

  3. Total Sleep Time During Post-taper

    Time frame: 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.

  4. Subjective Opiate Withdrawal Scale During Buprenorphine Taper

    Time frame: 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).

  5. Subjective Opiate Withdrawal Scale During Post-taper

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 28, 2018
Registry last updated
Aug 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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