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Medical Management of Sleep Disturbance During Opioid Tapering

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ClinicalTrials.gov Identifier: NCT03789214
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : July 4, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Opioid Dependence Opioid Withdrawal Sleep Disturbance Drug: Placebo oral capsule Drug: Low Dose Suvorexant Drug: High Dose Suvorexant Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Medical Management of Sleep Disturbance During Opioid Tapering
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders
Drug Information available for: Suvorexant

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo sleep medication (Placebo oral capsule)
Drug: Placebo oral capsule
Placebo Sleep Medication

Active Comparator: Low Dose Suvorexant
Low dose sleep medication
Drug: Low Dose Suvorexant
Low Dose Suvorexant

Active Comparator: High Dose Suvorexant
High dose sleep medication
Drug: High Dose Suvorexant
High Dose Suvorexant




Primary Outcome Measures :
  1. Total Sleep Time [ Time Frame: 8 nights ]
    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. Area-under-the-curve scores will represent two time frames: (1) four nights during an opioid taper, and (2) four nights post taper.

  2. Subjective Opiate Withdrawal Scale (SOWS) [ Time Frame: 6 days ]
    Area-under-the-curve of peak daily scores on the 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). Area-under-the-curve scores will represent two time frames: (1) three days during an opioid taper, and (2) three days post taper.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-reported male or female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789214


Contacts
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Contact: Andrew S Huhn, PhD 410-550-1971 ahuhn1@jhu.edu
Contact: Kelly E Dunn, PhD 410-550-2254 kdunn9@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Andrew S Huhn, PhD    410-550-1971    ahuhn1@jhu.edu   
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Andrew S Huhn, PhD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03789214     History of Changes
Other Study ID Numbers: IRB00198426
UG3DA048734 ( U.S. NIH Grant/Contract )
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Dyssomnias
Sleep Wake Disorders
Parasomnias
Opioid-Related Disorders
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Suvorexant
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Orexin Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action