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

Recruiting now

Conditions studied: Opioid Use Disorder, Sleep Disturbance

In brief

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.

Key facts

Study ID

NCT06104280

Run by

University of Alabama at Birmingham

People needed

200

Starts

2025-01-06

Expected to finish

2029-01-01

Last updated by the study team

2026-05-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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