Opioid Use DisorderMOUDNCT06104280
Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment
An observational study of Opioid Use Disorder and Sleep Disturbance, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder, Sleep Disturbance
- What is being tested?
- Post-Illumination Pupillary Response (PIPR), Polysomnography and Multiple Sleep Latency Test
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2025to 1 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study involves people who are receiving one of three medications for opioid use disorder (methadone, buprenorphine or naltrexone) or healthy controls.
Who may be able to join
- Adults (18+)
- prescribed one of three medications for opioid use disorder (methadone, XR-NTX, buprenorphine) or healthy control
- stable on MOUD (no dose change) for the past month
- positive on urine drug screen (UDS) for buprenorphine or methadone if prescribed those medications
Who cannot join
- 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;
- acutely suicidal, manic, intoxicated, or otherwise not stable enough to provide informed consent
- self-reported use of illicit opioids, stimulants (prescribed or illicit), or benzodiazepines/sedative/hypnotics in the past month
- alcohol or cannabis use disorder measured as severe on The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Checklist
- positive on UDS for illicit opioids (e.g., morphine, oxycodone, fentanyl),stimulants, benzodiazepines/sedative/hypnotics
- 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)
- persons diagnosed with narcolepsy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Brionna Smith, B.S., 205-975-7809, Cropseylab@uabmc.edu
Susan Dufour, MD, cropseylab@uabmc.edu
About this study
Official title: Medications for Opioid Use Disorder Differentially Modulate Intrinsically Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment (MOUD)
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.
Read the detailed description
Three medications for OUD (MOUD) are FDA-approved and regularly used to treat OUD: methadone, buprenorphine, and extended-release naltrexone (XR-NTX). However, persons who use opioids, including those prescribed MOUDs, report sleep disruption. In addition to the sleep centers of the brain, mu opioid receptors (MORs) are also expressed in the retina (including the human retina), specifically in ganglion cells that are critically important for non-image forming photoreception including circadian regulation of sleep-wake behavior. Pre-clinical studies show that activation of MORs on these intrinsically photosensitive retinal ganglion cells (ipRGCs) reduces the electrophysiological response to light, impacting critical ipRGC functions such as synchronization of sleep-wake behavior and circadian rhythms to light (photoentrainment), light-induced melatonin suppression, and the post-illumination pupillary reflex (PIPR). Together, these results suggest that activation of MORs in the ipRGCs by opioid use and/or MOUDs may impair downstream ipRGC functions. This multi-disciplinary study will examine the novel overarching hypothesis that persistent alterations in sleep/wake behavior in OUD patients undergoing treatment are mediated by impaired ipRGC function, and biomarkers of this pathway can predict recovery and relapse. Three aims will be tested in a sample of 200 participants, 150 of whom will be engaged in MOUD therapy (e.g., 50 each on methadone, buprenorphine, and XR-NTX, respectively) and 50 of whom will be non-opioid using control participants. Aim 1 will test the hypothesis that MOUD differentially impacts function of ipRGC responses. Aim 2 will examine whether MOUD differentially impacts daytime sleepiness, daily sleep-wake behavior, sleep architecture, and sleep-disordered breathing. Finally, Aim 3 will determine if ipRGC function predicts opioid relapse among MOUD groups at 1-, 3- and 6- month follow-up. Compared to non-opioid using controls or persons receiving an opioid antagonist (XR-NTX), we predict that participants who are receiving an agonist (methadone) or partial-agonist (buprenorphine) MOUD will have the most ipRGC interference, as evidenced by reduced PIPR, attenuated light-induced melatonin suppression, reduced circadian rhythmic amplitude, increased sleep latency, and increased sleep fragmentation. Importantly, we hypothesize that impaired ipRGC function will predict worse treatment outcomes as indicated by opioid use by 6-month follow-up. Finally, an exploratory aim will examine whether the MOUD groups show different relationships between opioid craving/withdrawal symptoms and sleep-wake behavior over a 10-day assessment of the participants' daily lives within the normal environment. The results of this study will be highly significant because it would support the use of the pupillary response to light and other indicators of ipRGC function as novel biomarkers to predict the response and outcomes to MOUDs.
- Conditions
- Opioid Use Disorder, Sleep Disturbance
- Being tested
- Post-Illumination Pupillary Response (PIPR), Polysomnography, Multiple Sleep Latency Test, Ecological Momentary Assessments, Actigraphy
- Keywords
- opioid use disorder, sleep, circadian rhythms, sleep disruption
- Medical subject headings
- Opioid-Related Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-Illumination Pupillary Response (PIPR)Other
Also called PIPR
The PIPR is measured in six, 80-s 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
PolysomnographyOther
Also called PSG
Measure electroencephalography (EEG), electrooculography (EOG), electromyography (EMG), electrocardiography (ECG), respiratory channels (effort and nasal pressure), and oxygen saturation.
Multiple Sleep Latency TestOther
Also called MSLT
Assist in the diagnosis of disorders of hypersomnolence,63 it is also used in research to quantify daytime sleepiness and serves as a more objective measure of daytime sleepiness than self-report questionnaires
Ecological Momentary AssessmentsBehavioural
Also called EMA
Morning after overnight Visit 2, participants will complete ecological momentary assessments (EMAs) over a 10-day assessment period. Using EMA through the InsightTM mHealth platform to capture momentary craving, withdrawal and mood states across 10 days among persons who smoke and nonsmokers prior to an overnight procedures. Participants will complete morning and evening sleep diaries via the EMA InsightTM mHealth platform self-reported sleep and wake information, fatigue, naps, opioid craving and withdrawal.
ActigraphyDevice
7-day actigraphy period will be used to determine the habitual sleep start and wake times. The CamNTech MotionWatch8 (Cambridge, UK) is a solid-state piezo-electric accelerometer that collects data on activity (i.e., arm motion) and ambient light.Actigraphy data are downloaded from the MotionWatch8 into the software (MotionWare) for analysis, management, and exportation. Bed and wake times will be entered by the subjects via a REDCap link and this information coupled with the sleep diary reports will be entered to determine sleep intervals. Algorithms in the Motion Watch 8 software will determine sleep start, sleep end, total sleep time (duration), sleep quality, sleep efficiency, wake after sleep onset, and sleep fragmentation
DLMOOther
Also called Dim Light Melatonin Onset
Participants will be given an evening meal and then be accompanied to the UAB Highlands Hospital Sleep Unit by 5:30pm. The sleep unit allows for strict control of light exposure (< 5 lux at eye level), room temperature and oral intake factors that could alter melatonin levels.Participants will be allowed to sleep in darkness until 8:00am, at which time they will be provided transportation.We will also bank frozen samples taken prior to the light exposure for later calculation of the Dim Light Melatonin Onset (DLMO), a circadian phase estimate.
Melatonin Suppression TestOther
The sleep unit allows for strict control of light exposure (< 5 lux at eye level), room temperature and oral intake factors that could alter melatonin levels. Participants will be asked to refrain from caffeine consumption 12 hours before reporting to the sleep unit and will provide 2-3 ml of saliva every 30 minutes starting at 6:00pm and ending after the light exposure. For melatonin suppression, 2-hours light exposure will begin 2 hours before the calculated mid-sleep time. Collection saliva samples 1-h, 30-min, and immediately before the light exposure and every 30 min throughout exposure. Samples will be centrifuged and frozen/stored at -20ºC until assay and remaining samples stored at -80ºC. Melatonin levels will be assayed via the Buhlmann Direct Saliva Melatonin. Melatonin suppression will be calculated as the percent decrease from the sample taken immediately prior to the light exposure
| Study group | Role | What they receive |
|---|---|---|
| MOUD therapy methadone | 50 methadone participants Receives: Other: Post-Illumination Pupillary Response (PIPR); Other: Polysomnography; Other: Multiple Sleep Latency Test; Behavioral: Ecological Momentary Assessments; Device: Actigraphy; Other: DLMO; Other: Melatonin Suppression Test | |
| MOUD therapy buprenorphine | 50 buprenorphine participants Receives: Other: Post-Illumination Pupillary Response (PIPR); Other: Polysomnography; Other: Multiple Sleep Latency Test; Behavioral: Ecological Momentary Assessments; Device: Actigraphy; Other: DLMO; Other: Melatonin Suppression Test | |
| MOUD therapy extended-release naltrexone | 50 extended-release naltrexone (XR-NTX) participants Receives: Other: Post-Illumination Pupillary Response (PIPR); Other: Polysomnography; Other: Multiple Sleep Latency Test; Behavioral: Ecological Momentary Assessments; Device: Actigraphy; Other: DLMO; Other: Melatonin Suppression Test | |
| Non-opioid using controls | non-opioid using controls Receives: Other: Post-Illumination Pupillary Response (PIPR); Other: Polysomnography; Other: Multiple Sleep Latency Test; Behavioral: Ecological Momentary Assessments; Device: Actigraphy; Other: DLMO; Other: Melatonin Suppression Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1: Post-Illumination Pupillary Response (PIPR)
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.
Measured: 45 minutes
Aim 2: Polysomnography
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.
Measured: 2 night PSG
Aim 3: Number of Participants Multiple Sleep Latency Test
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).
Measured: 2 night PSG
Aim 4: Number of Participants with Relapse
Self reported drug cravings, and self-reported withdrawal symptoms by 6-month follow up.Self-reported and urine drug screen confirmed drug use.
Measured: 6-month follow up
Secondary outcomes (2)
Dim Light Melatonin Onset (DLMO)
Samples taken prior to the light exposure for later calculation of the Dim Light Melatonin Onset (DLMO)
Measured: 12 hours
Melatonin suppression test
Melatonin suppression test, actigraphy parameters (rhythmic amplitude, inter-daily stability, intra-daily variation, sleep fragmentation, sleep efficiency, sleep duration, mid-sleep time, and wake after sleep onset), and sleep architecture (PSG). provide 2-3 ml of saliva every 30 min starting at 6:00pm and ending after the light exposure.Participants will be seated in a chair in front of a white light source lights will be calibrated for intensity and spectral distribution at eye level with a PR-670 spectrophotometer). During the light exposure, participants will be allowed to watch an unexciting movie on a 15-inch iPad tablet. Collect saliva samples 1-h, 30-min, and immediately before the light exposure and every 30 min throughout exposure. After the last sample, participants will be allowed to sleep in darkness until 8:00 am
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start6 Jan 2025
- Primary completion28 Dec 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Karen Gamble, University of Alabama at Birmingham
- Investigators
- Karen Cropsey, PsyD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104280
- Sponsor's protocol ID
- IRB-300011499
- Other IDs
- R01DA059471-01
- Acronym
- MOUD
- Status last verified
- Aug 2026
- First submitted
- 19 Sep 2023
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medications for Opioid Use Disorder Differentially Modulate Intrinsically Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment (MOUD)
- ClinicalTrials.gov ID
- NCT06104280
- Acronym / sponsor ID
- MOUD / IRB-300011499
- Conditions
- Opioid Use Disorder, Sleep Disturbance
- Keywords
- opioid use disorder, sleep, circadian rhythms, sleep disruption
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 28 Dec 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Three medications for OUD (MOUD) are FDA-approved and regularly used to treat OUD: methadone, buprenorphine, and extended-release naltrexone (XR-NTX). However, persons who use opioids, including those prescribed MOUDs, report sleep disruption. In addition to the sleep centers of the brain, mu opioid receptors (MORs) are also expressed in the retina (including the human retina), specifically in ganglion cells that are critically important for non-image forming photoreception including circadian regulation of sleep-wake behavior. Pre-clinical studies show that activation of MORs on these intrinsically photosensitive retinal ganglion cells (ipRGCs) reduces the electrophysiological response to light, impacting critical ipRGC functions such as synchronization of sleep-wake behavior and circadian rhythms to light (photoentrainment), light-induced melatonin suppression, and the post-illumination pupillary reflex (PIPR). Together, these results suggest that activation of MORs in the ipRGCs by opioid use and/or MOUDs may impair downstream ipRGC functions. This multi-disciplinary study will examine the novel overarching hypothesis that persistent alterations in sleep/wake behavior in OUD patients undergoing treatment are mediated by impaired ipRGC function, and biomarkers of this pathway can predict recovery and relapse. Three aims will be tested in a sample of 200 participants, 150 of whom will be engaged in MOUD therapy (e.g., 50 each on methadone, buprenorphine, and XR-NTX, respectively) and 50 of whom will be non-opioid using control participants. Aim 1 will test the hypothesis that MOUD differentially impacts function of ipRGC responses. Aim 2 will examine whether MOUD differentially impacts daytime sleepiness, daily sleep-wake behavior, sleep architecture, and sleep-disordered breathing. Finally, Aim 3 will determine if ipRGC function predicts opioid relapse among MOUD groups at 1-, 3- and 6- month follow-up. Compared to non-opioid using controls or persons receiving an opioid antagonist (XR-NTX), we predict that participants who are receiving an agonist (methadone) or partial-agonist (buprenorphine) MOUD will have the most ipRGC interference, as evidenced by reduced PIPR, attenuated light-induced melatonin suppression, reduced circadian rhythmic amplitude, increased sleep latency, and increased sleep fragmentation. Importantly, we hypothesize that impaired ipRGC function will predict worse treatment outcomes as indicated by opioid use by 6-month follow-up. Finally, an exploratory aim will examine whether the MOUD groups show different relationships between opioid craving/withdrawal symptoms and sleep-wake behavior over a 10-day assessment of the participants' daily lives within the normal environment. The results of this study will be highly significant because it would support the use of the pupillary response to light and other indicators of ipRGC function as novel biomarkers to predict the response and outcomes to MOUDs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MOUD therapy methadone | – | Other: Post-Illumination Pupillary Response (PIPR), Other: Polysomnography, Other: Multiple Sleep Latency Test, Behavioral: Ecological Momentary Assessments, Device: Actigraphy, Other: DLMO, Other: Melatonin Suppression Test50 methadone participants |
| MOUD therapy buprenorphine | – | Other: Post-Illumination Pupillary Response (PIPR), Other: Polysomnography, Other: Multiple Sleep Latency Test, Behavioral: Ecological Momentary Assessments, Device: Actigraphy, Other: DLMO, Other: Melatonin Suppression Test50 buprenorphine participants |
| MOUD therapy extended-release naltrexone | – | Other: Post-Illumination Pupillary Response (PIPR), Other: Polysomnography, Other: Multiple Sleep Latency Test, Behavioral: Ecological Momentary Assessments, Device: Actigraphy, Other: DLMO, Other: Melatonin Suppression Test50 extended-release naltrexone (XR-NTX) participants |
| Non-opioid using controls | – | Other: Post-Illumination Pupillary Response (PIPR), Other: Polysomnography, Other: Multiple Sleep Latency Test, Behavioral: Ecological Momentary Assessments, Device: Actigraphy, Other: DLMO, Other: Melatonin Suppression Testnon-opioid using controls |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study involves people who are receiving one of three medications for opioid use disorder (methadone, buprenorphine or naltrexone) or healthy controls.
Key inclusion criteria (4 listed)
- Adults (18+)
- prescribed one of three medications for opioid use disorder (methadone, XR-NTX, buprenorphine) or healthy control
- stable on MOUD (no dose change) for the past month
- positive on urine drug screen (UDS) for buprenorphine or methadone if prescribed those medications
Key exclusion criteria (7 listed)
- 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;
- acutely suicidal, manic, intoxicated, or otherwise not stable enough to provide informed consent
- self-reported use of illicit opioids, stimulants (prescribed or illicit), or benzodiazepines/sedative/hypnotics in the past month
- alcohol or cannabis use disorder measured as severe on The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Checklist
- positive on UDS for illicit opioids (e.g., morphine, oxycodone, fentanyl),stimulants, benzodiazepines/sedative/hypnotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post-Illumination Pupillary Response (PIPR)Also: PIPRThe PIPR is measured in six, 80-s 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 | Other | MOUD therapy buprenorphine, MOUD therapy extended-release naltrexone, MOUD therapy methadone, Non-opioid using controls |
| PolysomnographyAlso: PSGMeasure electroencephalography (EEG), electrooculography (EOG), electromyography (EMG), electrocardiography (ECG), respiratory channels (effort and nasal pressure), and oxygen saturation. | Other | MOUD therapy buprenorphine, MOUD therapy extended-release naltrexone, MOUD therapy methadone, Non-opioid using controls |
| Multiple Sleep Latency TestAlso: MSLTAssist in the diagnosis of disorders of hypersomnolence,63 it is also used in research to quantify daytime sleepiness and serves as a more objective measure of daytime sleepiness than self-report questionnaires | Other | MOUD therapy buprenorphine, MOUD therapy extended-release naltrexone, MOUD therapy methadone, Non-opioid using controls |
| Ecological Momentary AssessmentsAlso: EMAMorning after overnight Visit 2, participants will complete ecological momentary assessments (EMAs) over a 10-day assessment period. Using EMA through the InsightTM mHealth platform to capture momentary craving, withdrawal and mood states across 10 days among persons who smoke and nonsmokers prior to an overnight procedures. Participants will complete morning and evening sleep diaries via the EMA InsightTM mHealth platform self-reported sleep and wake information, fatigue, naps, opioid craving and withdrawal. | Behavioural | MOUD therapy buprenorphine, MOUD therapy extended-release naltrexone, MOUD therapy methadone, Non-opioid using controls |
| Actigraphy7-day actigraphy period will be used to determine the habitual sleep start and wake times. The CamNTech MotionWatch8 (Cambridge, UK) is a solid-state piezo-electric accelerometer that collects data on activity (i.e., arm motion) and ambient light.Actigraphy data are downloaded from the MotionWatch8 into the software (MotionWare) for analysis, management, and exportation. Bed and wake times will be entered by the subjects via a REDCap link and this information coupled with the sleep diary reports will be entered to determine sleep intervals. Algorithms in the Motion Watch 8 software will determine sleep start, sleep end, total sleep time (duration), sleep quality, sleep efficiency, wake after sleep onset, and sleep fragmentation | Device | MOUD therapy buprenorphine, MOUD therapy extended-release naltrexone, MOUD therapy methadone, Non-opioid using controls |
| DLMOAlso: Dim Light Melatonin OnsetParticipants will be given an evening meal and then be accompanied to the UAB Highlands Hospital Sleep Unit by 5:30pm. The sleep unit allows for strict control of light exposure (< 5 lux at eye level), room temperature and oral intake factors that could alter melatonin levels.Participants will be allowed to sleep in darkness until 8:00am, at which time they will be provided transportation.We will also bank frozen samples taken prior to the light exposure for later calculation of the Dim Light Melatonin Onset (DLMO), a circadian phase estimate. | Other | MOUD therapy buprenorphine, MOUD therapy extended-release naltrexone, MOUD therapy methadone, Non-opioid using controls |
| Melatonin Suppression TestThe sleep unit allows for strict control of light exposure (< 5 lux at eye level), room temperature and oral intake factors that could alter melatonin levels. Participants will be asked to refrain from caffeine consumption 12 hours before reporting to the sleep unit and will provide 2-3 ml of saliva every 30 minutes starting at 6:00pm and ending after the light exposure. For melatonin suppression, 2-hours light exposure will begin 2 hours before the calculated mid-sleep time. Collection saliva samples 1-h, 30-min, and immediately before the light exposure and every 30 min throughout exposure. Samples will be centrifuged and frozen/stored at -20ºC until assay and remaining samples stored at -80ºC. Melatonin levels will be assayed via the Buhlmann Direct Saliva Melatonin. Melatonin suppression will be calculated as the percent decrease from the sample taken immediately prior to the light exposure | Other | MOUD therapy buprenorphine, MOUD therapy extended-release naltrexone, MOUD therapy methadone, Non-opioid using controls |
Primary outcome
Aim 1: Post-Illumination Pupillary Response (PIPR)
Time frame: 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: Polysomnography
Time frame: 2 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 Test
Time frame: 2 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 Relapse
Time frame: 6-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.
2 secondary outcomes
Dim Light Melatonin Onset (DLMO)
Time frame: 12 hours
Melatonin suppression test
Time frame: 12 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karen Cropsey, PsyD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use Disorder and Sleep Disturbance, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen Gamble, PhD (205-975-7809, kcropsey@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1: Post-Illumination Pupillary Response (PIPR) (time frame: 45 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.