Status:
RECRUITING
Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid Use Disorder
Sleep Disturbance
Eligibility:
All Genders
18-80 years
Brief Summary
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 medic...
Detailed Description
Three medications for OUD (MOUD) are FDA-approved and regularly used to treat OUD: methadone, buprenorphine, and extended-release naltrexone (XR-NTX). However, persons who use opioids, including those...
Eligibility Criteria
Inclusion
- Adults (18+)
- prescribed one of three medications for opioid use disorder (methadone, XR-NTX, buprenorphine) or healthy control
- stable on MOUD (no dose change) for the past month
- positive on urine drug screen (UDS) for buprenorphine or methadone if prescribed those medications
Exclusion
- 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;
- acutely suicidal, manic, intoxicated, or otherwise not stable enough to provide informed consent
- self-reported use of illicit opioids, stimulants (prescribed or illicit), or benzodiazepines/sedative/hypnotics in the past month
- alcohol or cannabis use disorder measured as severe on The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Checklist
- positive on UDS for illicit opioids (e.g., morphine, oxycodone, fentanyl),stimulants, benzodiazepines/sedative/hypnotics
- 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)
- persons diagnosed with narcolepsy
Key Trial Info
Start Date :
January 6 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06104280
Start Date
January 6 2025
End Date
January 1 2029
Last Update
April 13 2025
Active Locations (2)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35226
2
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233