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NCT06104280 · ClinicalTrials.gov registry record
Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment
A clinical trial of Opioid Use Disorder and Sleep Disturbance, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- 200
- Enrollment target
- 2
- Study locations
NCT06104280: Recruiting study of Opioid Use Disorder and Sleep Disturbance, sponsored by University of Alabama at Birmingham.
NCT06104280 is a study of Opioid Use Disorder and Sleep Disturbance that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 200 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06104280, a study of Opioid Use Disorder and Sleep Disturbance, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
10-day at home actigraphy and ecological momentary assessments (EMA period), participants will be scheduled for Visit 3. Upon arrival, the non-dominant eye is dilated with Tropicamide 0.5% and Phenylephrine 2.5% (this lower-than-normal dilation dosage will be effective for the duration of the experiment but will fully dissipate within \~6 hours). Subjects are then seated in a dimly lit room (\< 5 lux, background light) for 30 minute to dark adapt and to ensure complete pupil dilation prior to th
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 |
What NCT06104280 shows while recruiting
NCT06104280 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (96% lower).
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.
NCT06104280 reports a single indexed study location in Alabama.
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.
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).
Who is sponsoring clinical trial NCT06104280?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06104280's enrollment target sits among peer trials
200 92nd of 257 higher than 163 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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