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Search / Trial NCT06104280

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

Opioid Use Disorder Sleep Circadian Rhythms Sleep Disruption

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.

Locations

Birmingham, Alabama, United States

Birmingham, Alabama, United States

Patients applied

0 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