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Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment
NCT06104280 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- OTHER Post-Illumination Pupillary Response (PIPR)
- OTHER Polysomnography
- OTHER Multiple Sleep Latency Test
- BEHAVIORAL Ecological Momentary Assessments
- DEVICE Actigraphy
Study Locations (2)
Alabama
- University of Alabama at Birmingham — Birmingham
- University of Alabama at Birmingham — Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2025-01-06 |
| Est. Completion | 2029-01-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06104280
The ClinicalTrials.gov registry entry for NCT06104280 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,315 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 5 interventions — of which Post-Illumination Pupillary Response (PIPR) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06104280 reports 2 study locations spanning 1 distinct geographic area — top geographies include Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06104280 about?
NCT06104280 is a clinical study titled "Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment". 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 investiga...
What is the current status of trial NCT06104280?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2025-01-06. Estimated completion is 2029-01-01.
What conditions does trial NCT06104280 study?
This clinical trial studies the following conditions: Opioid Use Disorder, Sleep Disturbance. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06104280?
The interventions under investigation include: Post-Illumination Pupillary Response (PIPR) (OTHER), Polysomnography (OTHER), Multiple Sleep Latency Test (OTHER), Ecological Momentary Assessments (BEHAVIORAL), Actigraphy (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06104280?
This trial is sponsored by University of Alabama at Birmingham, which has 1,315 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06104280 being conducted?
This trial has 2 study locations across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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