Observational Study on Opioid Use Disorder Medications, Vision, Sleep, and Circadian Rhythms
This study is looking at how medications for opioid use disorder (methadone, extended-release naltrexone, buprenorphine) might affect your vision, sleep, and body clock (circadian rhythms). Researchers believe that these medications might impact special cells in your eyes (photosensitive retinal ganglion cells) that help regulate sleep. You can join if you are an adult (18-80 years old) and are currently prescribed one of these medications for opioid use disorder, or if you are a healthy control. The study aims to understand if changes in these eye cells are linked to sleep problems in people with opioid use disorder, which could lead to new ways to improve treatment. The study plans to enroll 200 participants.
- Study design
- This is an observational study, meaning researchers will observe participants without providing new treatments. It plans to enroll 200 participants.
- What's involved
- You will undergo tests including measurements of your pupil response to light (PIPR), overnight sleep studies (polysomnography), and daytime sleepiness tests (Multiple Sleep Latency Test). You will also complete daily surveys on a mobile app for 10 days and wear a device to track your activity and sleep for 7 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your pupil response will be measured at 45 minutes, and sleep studies will involve 2 nights. Ecological Momentary Assessments will occur over a 10-day period, and actigraphy for 7 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Karen Cropsey, PsyD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Aim 1: Post-Illumination Pupillary Response (PIPR)45 minutes
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 the study. The PIPR is measured in six, 80-second test periods in which the stimulus, either Blue (470 nm) or Red (623 nm), is presented to the dilated eye while the pupil response of the un-dilated eye is measured (consensual pupil response). During a test period, after an initial 20-second fixation period, the stimulus is presented for 1 second followed by a 60-second fixation period. The red stimulus primarily serves as a control for any nonspecific influences on the PIPR.
- Aim 2: Polysomnography2 night PSG
Polysomnography (PSG)110: To avoid potential first-night effects often observed with PSG, participants will undergo two consecutive nights of PSG, scheduled to begin according to their habitual sleep/wake times. PSG will be conducted in dedicated research rooms located at the University of Alabama at Birmingham Sleep/Wake Disorders Center at Highlands Hospital (refer to Sleep and Circadian Research Core LOS). Trained staff will attach electrodes to measure electroencephalography (EEG), electrooculography (EOG), electromyography (EMG), electrocardiography (ECG), respiratory channels (effort and nasal pressure), and oxygen saturation. The values of the EEG, EOG, EMG, ECG respiratory channels, and oxygen saturation will be combined to report a single PSG value.
- Aim 3: Number of Participants Multiple Sleep Latency Test2 night PSG
On the morning following the second night of PSG, participants will undergo an MSLT following standardized guidelines. Briefly, the multiple sleep latency test (MSLT) consists of 5 nap opportunities that occur every two hours with the first nap beginning 1.5 to 3 hours after the end of the PSG (in this case, after the end of the 2nd night of PSG).
- Aim 4: Number of Participants with Relapse6-month follow up
Self reported drug cravings, and self-reported withdrawal symptoms by 6-month follow up.Self-reported and urine drug screen confirmed drug use.