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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversity of Alabama at Birmingham

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Post-Illumination Pupillary Response (PIPR)
  • Polysomnography
  • Multiple Sleep Latency Test
  • Ecological Momentary Assessments
  • Actigraphy
  • DLMO
  • Melatonin Suppression Test

Treatment groups

200 Participants
are divided into 4 treatment groups

Sponsors and collaborators

University of Alabama at Birmingham

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator