RECRUITING

Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment

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

Opioid use disorder (OUD) is a treatable medical illness with three medications FDA approved for treatment. However, persons with OUD report significant sleep disturbance, even when treated with medications for opioid use disorder, leading to high rates of relapse. In this project, we will investigate a special set of photosensitive neurons in the retina as an underlying mechanism for circadian rhythm and sleep disturbance from opioid use and medications for OUD that could lead to novel intervention and improve treatment outcomes.

Official Title

Medications for Opioid Use Disorder Differentially Modulate Intrinsically Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment (MOUD)

Quick Facts

Study Start:2025-01-06
Study Completion:2029-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06104280

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:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adults (18+)
  2. 2. prescribed one of three medications for opioid use disorder (methadone, XR-NTX, buprenorphine) or healthy control
  3. 3. stable on MOUD (no dose change) for the past month
  4. 4. positive on urine drug screen (UDS) for buprenorphine or methadone if prescribed those medications
  1. 1. eye disease reported by history or noted on exam including disease of the anterior and posterior segment of the eye, cataracts, retinopathy, glaucoma, cataracts, amblyopia, scotoma, color or night blindness, corneal pathologies, macular degeneration, or retinitis pigmentosa;
  2. 2. acutely suicidal, manic, intoxicated, or otherwise not stable enough to provide informed consent
  3. 3. self-reported use of illicit opioids, stimulants (prescribed or illicit), or benzodiazepines/sedative/hypnotics in the past month
  4. 4. alcohol or cannabis use disorder measured as severe on The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Checklist
  5. 5. positive on UDS for illicit opioids (e.g., morphine, oxycodone, fentanyl),stimulants, benzodiazepines/sedative/hypnotics
  6. 6. shift workers who work outside normal 7 a.m. to 6 p.m. hours, according to the National Institute of Occupational Safety and Health (NIOSH)
  7. 7. persons diagnosed with narcolepsy

Contacts and Locations

Study Contact

Karen Cropsey, PsyD
CONTACT
205-975-7809
kcropsey@uabmc.edu
Brionna Smith, B.S.
CONTACT
205-975-7809
cropseylab@uabmc.edu

Principal Investigator

Karen Cropsey, PsyD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35226
United States
University of Alabama at Birmingham
Birmingham, Alabama, 35233
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Karen Cropsey, PsyD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

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 Date2025-01-06
Study Completion Date2029-01-01

Study Record Updates

Study Start Date2025-01-06
Study Completion Date2029-01-01

Terms related to this study

Keywords Provided by Researchers

  • opioid use disorder
  • sleep
  • circadian rhythms
  • sleep disruption

Additional Relevant MeSH Terms

  • Opioid Use Disorder
  • Sleep Disturbance