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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-01-06 with a primary completion date of 2028-12-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. positive on UDS for illicit opioids (e.g., morphine, oxycodone, fentanyl),stimulants, benzodiazepines/sedative/hypnotics 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. persons diagnosed with narcolepsy
Contact & Investigator
Karen Cropsey, PsyD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT06104280 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Opioid Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06104280 currently recruiting?
Yes, NCT06104280 is actively recruiting participants. Contact the research team at kcropsey@uabmc.edu for enrollment information.
Where is the NCT06104280 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT06104280 clinical trial?
NCT06104280 is sponsored by University of Alabama at Birmingham. The principal investigator is Karen Cropsey, PsyD at University of Alabama at Birmingham. The trial plans to enroll 200 participants.