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Medical Management of Sleep Disturbance During Opioid Tapering

Primary Purpose

Opioid Dependence, Opioid Withdrawal, Sleep Disturbance

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo oral capsule
Low Dose Suvorexant
High Dose Suvorexant
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Dependence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

Low Dose Suvorexant

High Dose Suvorexant

Arm Description

Placebo sleep medication (Placebo oral capsule)

Low dose sleep medication

High dose sleep medication

Outcomes

Primary Outcome Measures

Abuse Liability as Assessed by Visual Analogue Scale
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.
Total Sleep Time During 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.
Total Sleep Time During Post-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
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).
Subjective Opiate Withdrawal Scale During Post-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).

Secondary Outcome Measures

Full Information

First Posted
December 26, 2018
Last Updated
July 12, 2022
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03789214
Brief Title
Medical Management of Sleep Disturbance During Opioid Tapering
Official Title
Medical Management of Sleep Disturbance During Opioid Tapering
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
June 10, 2021 (Actual)
Study Completion Date
June 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence, Opioid Withdrawal, Sleep Disturbance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo sleep medication (Placebo oral capsule)
Arm Title
Low Dose Suvorexant
Arm Type
Active Comparator
Arm Description
Low dose sleep medication
Arm Title
High Dose Suvorexant
Arm Type
Active Comparator
Arm Description
High dose sleep medication
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Placebo Sleep Medication
Intervention Type
Drug
Intervention Name(s)
Low Dose Suvorexant
Intervention Description
Low Dose Suvorexant
Intervention Type
Drug
Intervention Name(s)
High Dose Suvorexant
Intervention Description
High Dose Suvorexant
Primary Outcome Measure Information:
Title
Abuse Liability as Assessed by Visual Analogue Scale
Description
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.
Time Frame
4 nights
Title
Total Sleep Time During Buprenorphine Taper
Description
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.
Time Frame
Four nights during a buprenorphine taper
Title
Total Sleep Time During Post-taper
Description
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.
Time Frame
Four nights following buprenorphine discontinuation
Title
Subjective Opiate Withdrawal Scale During Buprenorphine Taper
Description
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).
Time Frame
Three days during a buprenorphine taper
Title
Subjective Opiate Withdrawal Scale During Post-taper
Description
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).
Time Frame
Three days following buprenorphine discontinuation

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Self-reported male or female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew S Huhn, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Medical Management of Sleep Disturbance During Opioid Tapering

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