search
Back to results

Examining the Role of the Orexin System in Sleep and Stress in Persons With Opioid Use Disorder

Primary Purpose

Sleep Disturbance, Opioid-use Disorder

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Suvorexant
Placebos
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disturbance

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Between the ages of 21-65, inclusive.
  • Past 30-day sleep disturbance as evidenced by a Pittsburgh Sleep Quality Index Total Score >5.
  • Enrolled in either outpatient methadone-maintenance, buprenorphine-maintenance, or XR-NTX treatment for OUD.
  • Willingness to be maintained on a protocolized dose starting between 60-130mg methadone or 380mg XR-NTX for the duration of the study.
  • At least two weeks of continuous abstinence from illicit opioids as evidenced by self-report and urine drug screens collected as part of routine care.
  • Willing to comply with the study protocol, which will include weekly study visits, daily actigraphy and ecological momentary assessments.
  • Use of birth control throughout study.
  • Have no clinically significant chronic medical disorders or conditions that are judged by the investigators to prevent participation.

Exclusion Criteria:

  • Serious mental illnesses that are unstable and could affect study participation (thought disorders, hallucinations, delusions, thoughts of harm to self/others).
  • Current moderate to severe substance use disorder other than OUD.
  • Current illicit stimulant use, including cocaine and methamphetamine.
  • Pregnant or breast feeding.
  • Have a known allergy to the study medications.
  • Past 30-day prescribed use of suvorexant.
  • Current use of a benzodiazepine or other schedule IV medication for insomnia.
  • Use of Cytochrome P450 3A inhibitors.
  • Current narcolepsy, sleep paralysis, or restless leg syndrome as assessed by medical history
  • Apnea-hypopnea index > 30.
  • Use of glucocorticoid medications and any medication that would alter the hypothalamic-pituitary-adrenal axis.
  • Past 30-day suicidal behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).
  • Have circumstances that would interfere with study participation (e.g., impending jail; severe clinical issues).

Sites / Locations

  • Man Alive Inc., Lane Treatment CenterRecruiting
  • Addiction Treatment Services at Johns Hopkins Bayview Medical CenterRecruiting
  • Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical CenterRecruiting
  • Ashley Addiction TreatmentRecruiting
  • Ashley Addiction TreatmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Suvorexant

Arm Description

Placebo sleep medication (2 placebo oral capsules)

Sleep medication (20mg suvorexant; 2 10mg capsules; patients can self-titrate to 1 10mg capsule)

Outcomes

Primary Outcome Measures

Total Sleep Time
Mean total number of minutes slept per night as measured by actigraphy and self-reported sleep diary. Mean total sleep time will be collected over a seven-night period in weeks 1, 4, and 8 of the trial.
Total Wake Time After Sleep Onset
Mean total number of minutes awake between initial sleep onset and final morning awakening, measured by actigraphy and self-reported sleep diary. Mean wake after sleep onset will be collected over a seven-night period in weeks 1, 4, and 8 of the trial.
Change in Perceived Stress Scale 4 (PSS-4) score
Mean daily scores on the PSS-4 (a four item scale self-reported scale than measures stress using a 0-4 Likert scale; total range of PSS-4 scores is 0-16; lower scores indicate lower daily stress relative to higher scores, which indicate higher daily stress). Mean PSS-4 scores will be collected over a seven-day period in weeks 1, 4, and 8 of the trial.

Secondary Outcome Measures

Full Information

First Posted
February 25, 2020
Last Updated
August 15, 2023
Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
search

1. Study Identification

Unique Protocol Identification Number
NCT04287062
Brief Title
Examining the Role of the Orexin System in Sleep and Stress in Persons With Opioid Use Disorder
Official Title
Examining the Role of the Orexin System in Sleep and Stress in Persons With Opioid Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

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
Yes

5. Study Description

Brief Summary
This study is designed to elucidate the role of the orexin neurotransmitter system in sleep disturbance and circadian rhythms of stress that might in turn influence relapse behaviors in persons on medication-assisted treatments (MAT) who are in early recovery from opioid use disorder (OUD). Briefly, the study will enroll recently abstinent OUD patients (N=200) maintained on either extended-release naltrexone (XR-NTX), buprenorphine, or methadone. Within each MAT group, participants will be randomized to either suvorexant or placebo. The study is expected to have a 20% treatment attrition rate which will result in N=160 completers in the entire study. Patients will be recruited from and treated at Ashley Addiction Treatment, Addiction Treatment Services at Johns Hopkins Bayview Medical Center, Man Alive, or community providers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance, Opioid-use Disorder

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo sleep medication (2 placebo oral capsules)
Arm Title
Suvorexant
Arm Type
Active Comparator
Arm Description
Sleep medication (20mg suvorexant; 2 10mg capsules; patients can self-titrate to 1 10mg capsule)
Intervention Type
Drug
Intervention Name(s)
Suvorexant
Intervention Description
Dual orexin receptor antagonist
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Weight and color matched placebo
Primary Outcome Measure Information:
Title
Total Sleep Time
Description
Mean total number of minutes slept per night as measured by actigraphy and self-reported sleep diary. Mean total sleep time will be collected over a seven-night period in weeks 1, 4, and 8 of the trial.
Time Frame
21 nights
Title
Total Wake Time After Sleep Onset
Description
Mean total number of minutes awake between initial sleep onset and final morning awakening, measured by actigraphy and self-reported sleep diary. Mean wake after sleep onset will be collected over a seven-night period in weeks 1, 4, and 8 of the trial.
Time Frame
21 nights
Title
Change in Perceived Stress Scale 4 (PSS-4) score
Description
Mean daily scores on the PSS-4 (a four item scale self-reported scale than measures stress using a 0-4 Likert scale; total range of PSS-4 scores is 0-16; lower scores indicate lower daily stress relative to higher scores, which indicate higher daily stress). Mean PSS-4 scores will be collected over a seven-day period in weeks 1, 4, and 8 of the trial.
Time Frame
21 days (collected over a seven-day period in weeks 1, 4, and 8 of the trial)

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Self-reported male or female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between the ages of 21-65, inclusive. Past 30-day sleep disturbance as evidenced by a Pittsburgh Sleep Quality Index Total Score >5. Enrolled in either outpatient methadone-maintenance, buprenorphine-maintenance, or XR-NTX treatment for OUD. Willingness to be maintained on a protocolized dose starting between 60-130mg methadone or 380mg XR-NTX for the duration of the study. At least two weeks of continuous abstinence from illicit opioids as evidenced by self-report and urine drug screens collected as part of routine care. Willing to comply with the study protocol, which will include weekly study visits, daily actigraphy and ecological momentary assessments. Use of birth control throughout study. Have no clinically significant chronic medical disorders or conditions that are judged by the investigators to prevent participation. Exclusion Criteria: Serious mental illnesses that are unstable and could affect study participation (thought disorders, hallucinations, delusions, thoughts of harm to self/others). Current moderate to severe substance use disorder other than OUD. Current illicit stimulant use, including cocaine and methamphetamine. Pregnant or breast feeding. Have a known allergy to the study medications. Past 30-day prescribed use of suvorexant. Current use of a benzodiazepine or other schedule IV medication for insomnia. Use of Cytochrome P450 3A inhibitors. Current narcolepsy, sleep paralysis, or restless leg syndrome as assessed by medical history Apnea-hypopnea index > 30. Use of glucocorticoid medications and any medication that would alter the hypothalamic-pituitary-adrenal axis. Past 30-day suicidal behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS). Have circumstances that would interfere with study participation (e.g., impending jail; severe clinical issues).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew S Huhn, PhD
Phone
410-550-1971
Email
ahuhn1@jhu.edu
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
Man Alive Inc., Lane Treatment Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Reese, M.A.
Phone
410-837-4292
Ext
300
Email
kreese@manaliveinc.org
Facility Name
Addiction Treatment Services at Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew S Huhn, PhD
Phone
410-550-1971
Email
ahuhn1@jhu.edu
Facility Name
Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew S Huhn, PhD
Phone
410-550-1971
Email
ahuhn1@jhu.edu
Facility Name
Ashley Addiction Treatment
City
Bel Air
State/Province
Maryland
ZIP/Postal Code
21014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew S Huhn, PhD
Phone
410-550-1971
Email
ahuhn1@jhu.edu
Facility Name
Ashley Addiction Treatment
City
Elkton
State/Province
Maryland
ZIP/Postal Code
21921
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew S Huhn, PhD
Phone
410-550-1971
Email
ahuhn1@jhu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Examining the Role of the Orexin System in Sleep and Stress in Persons With Opioid Use Disorder

We'll reach out to this number within 24 hrs