We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04287062
Recruitment Status : Recruiting
First Posted : February 27, 2020
Last Update Posted : May 20, 2022
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Sleep Disturbance Opioid-use Disorder Drug: Suvorexant Drug: Placebos Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Examining the Role of the Orexin System in Sleep and Stress in Persons With Opioid Use Disorder
Actual Study Start Date : November 20, 2020
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Suvorexant

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo sleep medication (2 placebo oral capsules)
Drug: Placebos
Weight and color matched placebo

Active Comparator: Suvorexant
Sleep medication (20mg suvorexant; 2 10mg capsules; patients can self-titrate to 1 10mg capsule)
Drug: Suvorexant
Dual orexin receptor antagonist




Primary Outcome Measures :
  1. Total Sleep Time [ Time Frame: 21 nights ]
    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.

  2. Total Wake Time After Sleep Onset [ Time Frame: 21 nights ]
    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.

  3. Change in Perceived Stress Scale 4 (PSS-4) score [ Time Frame: 21 days (collected over a seven-day period in weeks 1, 4, and 8 of the trial) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 65 Years   (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:

  • 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).

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): NCT04287062


Contacts
Layout table for location contacts
Contact: Andrew S Huhn, PhD 410-550-1971 ahuhn1@jhu.edu

Locations
Layout table for location information
United States, Maryland
Man Alive Inc., Lane Treatment Center Recruiting
Baltimore, Maryland, United States, 21218
Contact: Karen Reese, M.A.    410-837-4292 ext 300    kreese@manaliveinc.org   
Addiction Treatment Services at Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Andrew S Huhn, PhD    410-550-1971    ahuhn1@jhu.edu   
Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical Center Recruiting
Baltimore, Maryland, United States, 21224
Contact: Andrew S Huhn, PhD    410-550-1971    ahuhn1@jhu.edu   
Ashley Addiction Treatment Recruiting
Bel Air, Maryland, United States, 21014
Contact: Andrew S Huhn, PhD    410-550-1971    ahuhn1@jhu.edu   
Ashley Addiction Treatment Recruiting
Elkton, Maryland, United States, 21921
Contact: Andrew S Huhn, PhD    410-550-1971    ahuhn1@jhu.edu   
Sponsors and Collaborators
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Layout table for investigator information
Principal Investigator: Andrew S Huhn, PhD Johns Hopkins University
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04287062    
Other Study ID Numbers: IRB00223942
U01HL150835 ( U.S. NIH Grant/Contract )
First Posted: February 27, 2020    Key Record Dates
Last Update Posted: May 20, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Dyssomnias
Parasomnias
Opioid-Related Disorders
Substance-Related Disorders
Narcotic-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Sleep Wake Disorders
Nervous System Diseases
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