Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment
Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Oct 24, 2023
Trial Information
Current as of July 21, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring how certain medications for opioid use disorder (OUD) affect sleep and circadian rhythms, which are our natural sleep-wake cycles. Although there are effective FDA-approved medications for OUD, many people still experience sleep problems, which can lead to a higher chance of relapse. Researchers will look at specific neurons in the eye that might be linked to these sleep disturbances to find better ways to help improve treatment for individuals struggling with OUD.
To participate, you need to be an adult aged 18 or older who is currently stable on one of the three approved OUD medications (methadone, buprenorphine, or XR-NTX) for at least a month. You will also need to have a positive urine drug test for the medication you are taking. However, if you have certain eye diseases, a history of severe mental health issues, or use illicit drugs or alcohol, you may not be eligible. Participants can expect to engage in research that could lead to new insights on how to improve sleep and overall treatment outcomes for those with OUD.
Gender
ALL
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
About University Of Alabama At Birmingham
The University of Alabama at Birmingham (UAB) is a prominent academic institution and research hub dedicated to advancing healthcare through innovative clinical trials. Renowned for its commitment to medical discovery and education, UAB conducts cutting-edge research across a wide array of disciplines, including oncology, cardiology, neurology, and public health. With a robust infrastructure for clinical research, UAB fosters collaboration among interdisciplinary teams, leveraging state-of-the-art facilities and resources to enhance the translation of scientific findings into effective treatments and interventions. As a leader in clinical research, UAB aims to improve patient outcomes and contribute to the broader medical community through rigorous trial design and implementation.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Patients applied
Trial Officials
Karen Cropsey, PsyD
Principal Investigator
University of Alabama at Birmingham
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported