Investigating how opioid use affects sleep and circadian rhythms

Medications for Opioid Use Disorder Differentially Modulate Intrinsically Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment (MOUD)

This study is trying to see how opioid use affects sleep and body clock patterns in people with opioid use disorder to find better ways to help them recover.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of Alabama at Birmingham (other)
• Locations: 1 site (Birmingham, Alabama)
• Trial ID: NCT06104280 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are stable on one of the three FDA-approved medications for opioid use disorder.

Not a fit: Patients with significant eye diseases or those who are acutely unstable or have severe substance use disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for individuals with opioid use disorder by addressing sleep disturbances.

How similar studies have performed: While the specific approach of examining retinal ganglion cell function in relation to opioid use and sleep is novel, related studies have shown the importance of sleep in recovery from substance use disorders.

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

Where this trial is running

Birmingham, Alabama

• 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 Cropsey, PsyD

Conditions: Opioid Use Disorder, Sleep Disturbance, opioid use disorder, sleep, circadian rhythms, sleep disruption