NCT06104280 Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment
| NCT ID | NCT06104280 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Opioid Use Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-01-06 |
| Primary Completion | 2028-12-28 |
Trial Parameters
Eligibility Fast-Check
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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 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.
Eligibility Criteria
Inclusion Criteria: 1. Adults (18+) 2. prescribed one of three medications for opioid use disorder (methadone, XR-NTX, buprenorphine) or healthy control 3. stable on MOUD (no dose change) for the past month 4. positive on urine drug screen (UDS) for buprenorphine or methadone if prescribed those medications Exclusion Criteria: 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. acutely suicidal, manic, intoxicated, or otherwise not stable enough to provide informed consent 3. self-reported use of illicit opioids, stimulants (prescribed or illicit), or benzodiazepines/sedative/hypnotics in the past month 4. alcohol or cannabis use disorder measured as severe on The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Checklist 5. positiv