Investigating how opioid use affects sleep and circadian rhythms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the relationship between opioid use disorder (OUD) and sleep disturbances, focusing on the role of photosensitive retinal ganglion cells in regulating circadian rhythms. It will involve 200 participants, including 150 individuals undergoing medication-assisted treatment for OUD with methadone, buprenorphine, or extended-release naltrexone. The study will utilize various assessments, such as polysomnography and ecological momentary assessments, to evaluate sleep patterns and potential biomarkers that could predict recovery and relapse. By understanding these mechanisms, the research seeks to identify novel interventions to improve treatment outcomes for patients with OUD.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting

Study contacts

• Principal investigator: Karen Cropsey, PsyD — University of Alabama at Birmingham
• Study coordinator: Karen Gamble, PhD
• Email: kcropsey@uabmc.edu
• Phone: 205-975-7809

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.