COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-11-20
Study Completion:2025-08-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04287062

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Between the ages of 21-65, inclusive.
  2. * Past 30-day sleep disturbance as evidenced by a Pittsburgh Sleep Quality Index Total Score \>5.
  3. * Enrolled in either outpatient methadone-maintenance, buprenorphine-maintenance, or XR-NTX treatment for OUD.
  4. * Willingness to be maintained on a protocolized dose starting between 60-130mg methadone or 380mg XR-NTX for the duration of the study.
  5. * 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.
  6. * Willing to comply with the study protocol, which will include weekly study visits, daily actigraphy and ecological momentary assessments.
  7. * Use of birth control throughout study.
  8. * Have no clinically significant chronic medical disorders or conditions that are judged by the investigators to prevent participation.
  1. * Serious mental illnesses that are unstable and could affect study participation (thought disorders, hallucinations, delusions, thoughts of harm to self/others).
  2. * Current moderate to severe substance use disorder other than OUD.
  3. * Current illicit stimulant use, including cocaine and methamphetamine.
  4. * Pregnant or breast feeding.
  5. * Have a known allergy to the study medications.
  6. * Past 30-day prescribed use of suvorexant.
  7. * Current use of a benzodiazepine or other schedule IV medication for insomnia.
  8. * Use of Cytochrome P450 3A inhibitors.
  9. * Current narcolepsy, sleep paralysis, or restless leg syndrome as assessed by medical history
  10. * Apnea-hypopnea index \> 30.
  11. * Use of glucocorticoid medications and any medication that would alter the hypothalamic-pituitary-adrenal axis.
  12. * Past 30-day suicidal behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).
  13. * Have circumstances that would interfere with study participation (e.g., impending jail; severe clinical issues).

Contacts and Locations

Principal Investigator

Andrew S Huhn, PhD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Man Alive Inc., Lane Treatment Center
Baltimore, Maryland, 21218
United States
Addiction Treatment Services at Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
United States
Behavioral Pharmacology Research Unit at the Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
United States
Ashley Addiction Treatment
Bel Air, Maryland, 21014
United States
Ashley Addiction Treatment
Elkton, Maryland, 21921
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Andrew S Huhn, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-20
Study Completion Date2025-08-15

Study Record Updates

Study Start Date2020-11-20
Study Completion Date2025-08-15

Terms related to this study

Additional Relevant MeSH Terms

  • Sleep Disturbance
  • Opioid-use Disorder