Opioid Use DisorderNCT06832007
The Effect of Light Intervention on Recovery in Individuals With Opioid Use Disorder (OUD)
A study testing AYO light glasses (experimental) and AYO light glasses (comparator) in people with Opioid Use Disorder and Sleep, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Opioid use disorder (OUD) is a chronic relapsing disorder and is well-known for its high-risk rate of overdoses and death. In OUD, sleep and circadian disruptions are highly prevalent, interfere with opioid maintenance treatment outcomes and increase the risk of relapse. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder, Sleep, Circadian Rhythms
- What is being tested?
- AYO light glasses (experimental) and AYO light glasses (comparator)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2025to 16 Sep 2028
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All Participants
- Between 18 and 60 years old
- Fluent in English
- Able to provide written informed consent
- OUD
- DSM-5 diagnosis of an OUD.
Show all 10Show fewer
- ≥12 months of lifetime opioid use
- Positive on urine drug screen for buprenorphine or methadone
- Receiving opioid agonist therapy for OUD (e.g., methadone or buprenorphine) with a stable dose for the past month. Must have been stabilized on OMT medication, since the increasing of doses during induction phase might interfere with outcomes and unstable patients might experience strong withdrawal symptoms in the morning which makes them unsuitable for a home-based BLT.
- Other substance use was not exclusionary, but opioids were identified as primary.
Who cannot join
- All Participants
- Head trauma with loss of consciousness for more than 30 minutes as determined by medical history.
- history of seizures/epilepsy.
- Pregnant and/or currently breast-feeding.
- Presence of ferromagnetic objects in the body that are contraindicated for MRI or fear of enclosed spaces.
- Eye disease including disease of the anterior and posterior segment of the eye, cataracts, retinopathy, glaucoma, amblyopia, scotoma, color or night blindness, corneal pathologies, macular degeneration, or retinitis pigmentosa reported by history or identified by eye exam
Show all 17Show fewer
- History of eye surgery
- Chronic migraine triggered by bright light
- worked night shift or traveled across>2 time zones in the past month
- OUD
- diagnosis of substance use disorder other than for opioids that was deemed to be primary
- lifetime diagnosis of schizophrenia, bipolar disorder, or suicidality.
- History of light treatment
- Unstable dose of psychiatric medication (hypnotics, sleep aids, and antidepressants must be stable for 30 days before and during the study)
- HC
- Current or past DSM-IV or DSM-5 diagnosis of a psychiatric disorder including substance use disorder (except for nicotine/caffeine).
- Current DSM-5 sleep-wake disorders including insomnia disorder
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, 35294
Rui Zhang, 2059966170, ruizhang@uabmc.edu
About this study
Opioid use disorder (OUD) is a chronic relapsing disorder and is well-known for its high-risk rate of overdoses and death. In OUD, sleep and circadian disruptions are highly prevalent, interfere with opioid maintenance treatment outcomes and increase the risk of relapse. So far, commonly used pharmacological sleep treatments fail to improve sleep or decrease illicit drug use in OUD. Thus, there is an urgent need to fill this research gap.
Previous work showed that OUD patients who were receiving opioid agonist treatment (MOUD+) exhibited greater irregularity of sleep-wake cycle. In OUD patients, sleep-wake irregularity was associated with years of heroin use and low light exposure. Bright light therapy (BLT) is a very promising circadian/sleep intervention for several sleep, psychiatric and neurological disorders. BLT improved circadian, sleep outcomes and negative mood. In a pilot study, BLT improved objective and subjective sleep in patients with alcohol use disorder. Here investigators proposed an intervention study for MOUD+ patients to determine effects of BLT as an adjunct treatment on sleep and circadian outcomes including endogenous circadian rhythm, rest-activity rhythm and sleep neurophysiology (Primary objectives); and to determine effects of BLT on brain function and on clinical outcomes including negative affect, craving and illicit drug use and whether changes in sleep and circadian rhythm mediate the BLT effect on brain recovery and clinical outcomes (Secondary objectives).
Fifty MOUD+ will be assigned either to bright light or to dim light group for 2 weeks. The groups will be matched for age, sex, race and OUD medication (Methadone vs Buprenorphine). The study will run throughout the year such that it occurs during all seasons. Light exposure will be measured with light sensor for additional control. All MOUD+ participants will have a daily 30-min light exposure (bright or dim blue light) in the morning after their habitual wake-up time and will be asked to avoid evening light before bed. Dim light melatonin onset, accelerometer, sleep EEG and questionnaires will be used to measure objective and subjective sleep and circadian outcomes. For brain function, cue-reactivity task will be used to assess brain activation during drug craving. Resting state functional connectivity and brain state dynamics will be assessed by rsfMRI. Mood, opiate craving and illicit drug use will be assessed. All measures will be repeated before and after the treatment. Investigators expect that BLT would normalize sleep and circadian outcomes, attenuate impairments in brain functions and result in better clinical outcomes. If successful, light therapy will provide add-on benefits to opioid agonist therapy and facilitate OUD recovery process.
- Conditions
- Opioid Use Disorder, Sleep, Circadian Rhythms, fMRI Research
- Being tested
- AYO light glasses (experimental), AYO light glasses (comparator)
- Keywords
- opioid use disorder, sleep, circadian rhythms, fMRI research
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AYO light glasses (experimental)Device
OUD patients are asked to wear AYO light therapy glasses (wavelength 470nm ± 2nm, irradiance 250 μW/cm2 or approx.1500 m-EDI) daily for 30 min after habitual wake-up times for two weeks.
AYO light glasses (comparator)Device
The comparison group will wear the same AYO glasses but with lower intensity (1% light intensity) compared to the experimental group. This group will also self-administer 30 min of light from commercially available light glasses each morning for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental light | Experimental | MOUD participants Receives: Device: AYO light glasses (experimental) |
| Comparison light | Active comparator | MOUD participants Receives: Device: AYO light glasses (comparator) |
| Healthy control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dim light melatonin onset (DLMO)
DLMO is assessed for endogenous circadian phase.Participants will be asked to remain awake in dim light < 5 lux. Salivary melatonin sample will be collected hourly and start 5h before habitual bedtime. Melatonin concentration will be later radioimmunoassayed. DLMO will be calculated as the time when melatonin concentration exceeds and remains above 4 pg/mL.
Measured: the day directly before and after the intervention
melatonin metabolites level
Participants will be asked to collect their first morning urine void (overnight urine) upon waking. Urinary metabolite of melatonin 6-sulphatoxymelatonin (aMT6s) will be quantified and normalized to urinary creatinine concentrations to account for variations in urine concentration.
Measured: the day directly before and after the intervention
Sleep-wake regularity
To record rest-activity/sleep-wake patterns, participants are asked to wear a triaxial accelerometer placed on the non-dominant wrist continuously throughout the study.
Measured: From the enrollment to the end of the treatment at 24 days
Total sleep duration
total sleep duration (hours) will be measured by sleep EEG. Participants will be asked to wear a wireless sleep monitor device during sleep in their home environment.
Measured: From the enrollment to the end of the treatment at 24 days; 2-3 nights per week
N3 sleep
N3 sleep (hours) will be measured by sleep EEG. Participants will be asked to wear a wireless sleep monitor device during sleep in their home environment.
Measured: From the enrollment to the end of the treatment at 24 days; 2-3 nights per week
REM sleep
REM sleep (hours) will be measured by sleep EEG. Participants will be asked to wear a wireless sleep monitor device during sleep in their home environment.
Measured: From the enrollment to the end of the treatment at 24 days; 2-3 nights per week
sleep spindle
Amount of sleep spindle will be measured by sleep EEG. Participants will be asked to wear a wireless sleep monitor device during sleep in their home environment.
Measured: From the enrollment to the end of the treatment at 24 days; 2-3 nights per week
Secondary outcomes (3)
brain signiture of craving measured by cue reactivity task
Participants will passively view neutral, food and opioid related pictures. Brain activity during the picture viewing will be captured.
Measured: the day prior to the intervention and the day after the intervention
brain functions during resting state
resting state fMRI data will be collected over an 8-min period of time. Brain functional connectivity and brain state transitions will be calculated
Measured: the day before and after light intervention
Ecological momentary assessment (EMA)
self-reported mood, opioid craving, withdrawal symptoms and illicit drug use will be captured by EMA surveys. The MetricWire platform will be utilized for EMA surveys. Sleep-related questions will be prompted within 1 hour of the participant's habitual wake-up time. For the OUD group, additional questions will include prior day's illicit drug use and the usage of buprenorphine and methadone (time and dose). Light therapy-related questions, including onset and offset times, adverse effects, and changes in positive and negative mood after the daily therapy session, will be collected before 1 pm. Questions on mood, craving, and pain severity will be delivered at six semi-random timepoints each day during the participant's waking hours.
Measured: From the enrollment to the end of the treatment at 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start6 Sep 2025
- Primary completion16 Sep 2028 (estimated)
- Study completion16 Sep 2028 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rui Zhang, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832007
- Sponsor's protocol ID
- IRB-300014352
- Other IDs
- 31322
- Status last verified
- Oct 2026
- First submitted
- 6 Feb 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Light Intervention on Recovery in Individuals With Opioid Use Disorder (OUD)
- ClinicalTrials.gov ID
- NCT06832007
- Acronym / sponsor ID
- IRB-300014352
- Conditions
- Opioid Use Disorder, Sleep, Circadian Rhythms, fMRI Research
- Keywords
- opioid use disorder, sleep, circadian rhythms, fMRI research
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 6 Sep 2025 (actual)
- Primary completion
- 16 Sep 2028 (estimated)
- Study completion
- 16 Sep 2028 (estimated)
- First posted
- 18 Feb 2025 (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 chronic relapsing disorder and is well-known for its high-risk rate of overdoses and death. In OUD, sleep and circadian disruptions are highly prevalent, interfere with opioid maintenance treatment outcomes and increase the risk of relapse. So far, commonly used pharmacological sleep treatments fail to improve sleep or decrease illicit drug use in OUD. Thus, there is an urgent need to fill this research gap.
Previous work showed that OUD patients who were receiving opioid agonist treatment (MOUD+) exhibited greater irregularity of sleep-wake cycle. In OUD patients, sleep-wake irregularity was associated with years of heroin use and low light exposure. Bright light therapy (BLT) is a very promising circadian/sleep intervention for several sleep, psychiatric and neurological disorders. BLT improved circadian, sleep outcomes and negative mood. In a pilot study, BLT improved objective and subjective sleep in patients with alcohol use disorder. Here investigators proposed an intervention study for MOUD+ patients to determine effects of BLT as an adjunct treatment on sleep and circadian outcomes including endogenous circadian rhythm, rest-activity rhythm and sleep neurophysiology (Primary objectives); and to determine effects of BLT on brain function and on clinical outcomes including negative affect, craving and illicit drug use and whether changes in sleep and circadian rhythm mediate the BLT effect on brain recovery and clinical outcomes (Secondary objectives).
Fifty MOUD+ will be assigned either to bright light or to dim light group for 2 weeks. The groups will be matched for age, sex, race and OUD medication (Methadone vs Buprenorphine). The study will run throughout the year such that it occurs during all seasons. Light exposure will be measured with light sensor for additional control. All MOUD+ participants will have a daily 30-min light exposure (bright or dim blue light) in the morning after their habitual wake-up time and will be asked to avoid evening light before bed. Dim light melatonin onset, accelerometer, sleep EEG and questionnaires will be used to measure objective and subjective sleep and circadian outcomes. For brain function, cue-reactivity task will be used to assess brain activation during drug craving. Resting state functional connectivity and brain state dynamics will be assessed by rsfMRI. Mood, opiate craving and illicit drug use will be assessed. All measures will be repeated before and after the treatment. Investigators expect that BLT would normalize sleep and circadian outcomes, attenuate impairments in brain functions and result in better clinical outcomes. If successful, light therapy will provide add-on benefits to opioid agonist therapy and facilitate OUD recovery process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental light | Experimental | Device: AYO light glasses (experimental)MOUD participants |
| Comparison light | Active comparator | Device: AYO light glasses (comparator)MOUD participants |
| Healthy control | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- All Participants
- Between 18 and 60 years old
- Fluent in English
- Able to provide written informed consent
- OUD
Key exclusion criteria (17 listed)
- All Participants
- Head trauma with loss of consciousness for more than 30 minutes as determined by medical history.
- history of seizures/epilepsy.
- Pregnant and/or currently breast-feeding.
- Presence of ferromagnetic objects in the body that are contraindicated for MRI or fear of enclosed spaces.
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 |
|---|---|---|
| AYO light glasses (experimental)OUD patients are asked to wear AYO light therapy glasses (wavelength 470nm ± 2nm, irradiance 250 μW/cm2 or approx.1500 m-EDI) daily for 30 min after habitual wake-up times for two weeks. | Device | Experimental light |
| AYO light glasses (comparator)The comparison group will wear the same AYO glasses but with lower intensity (1% light intensity) compared to the experimental group. This group will also self-administer 30 min of light from commercially available light glasses each morning for two weeks | Device | Comparison light |
Primary outcome
Dim light melatonin onset (DLMO)
Time frame: the day directly before and after the intervention
DLMO is assessed for endogenous circadian phase.Participants will be asked to remain awake in dim light < 5 lux. Salivary melatonin sample will be collected hourly and start 5h before habitual bedtime. Melatonin concentration will be later radioimmunoassayed. DLMO will be calculated as the time when melatonin concentration exceeds and remains above 4 pg/mL.
melatonin metabolites level
Time frame: the day directly before and after the intervention
Participants will be asked to collect their first morning urine void (overnight urine) upon waking. Urinary metabolite of melatonin 6-sulphatoxymelatonin (aMT6s) will be quantified and normalized to urinary creatinine concentrations to account for variations in urine concentration.
Sleep-wake regularity
Time frame: From the enrollment to the end of the treatment at 24 days
To record rest-activity/sleep-wake patterns, participants are asked to wear a triaxial accelerometer placed on the non-dominant wrist continuously throughout the study.
Total sleep duration
Time frame: From the enrollment to the end of the treatment at 24 days; 2-3 nights per week
total sleep duration (hours) will be measured by sleep EEG. Participants will be asked to wear a wireless sleep monitor device during sleep in their home environment.
N3 sleep
Time frame: From the enrollment to the end of the treatment at 24 days; 2-3 nights per week
N3 sleep (hours) will be measured by sleep EEG. Participants will be asked to wear a wireless sleep monitor device during sleep in their home environment.
REM sleep
Time frame: From the enrollment to the end of the treatment at 24 days; 2-3 nights per week
REM sleep (hours) will be measured by sleep EEG. Participants will be asked to wear a wireless sleep monitor device during sleep in their home environment.
sleep spindle
Time frame: From the enrollment to the end of the treatment at 24 days; 2-3 nights per week
Amount of sleep spindle will be measured by sleep EEG. Participants will be asked to wear a wireless sleep monitor device during sleep in their home environment.
3 secondary outcomes
brain signiture of craving measured by cue reactivity task
Time frame: the day prior to the intervention and the day after the intervention
brain functions during resting state
Time frame: the day before and after light intervention
Ecological momentary assessment (EMA)
Time frame: From the enrollment to the end of the treatment at 24 days
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 9 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AYO light glasses (experimental) and AYO light glasses (comparator) in people with Opioid Use Disorder and Sleep, 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 10 inclusion and 17 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 9 Oct 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 Rui Zhang, PhD (2059966170, rzhang5@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dim light melatonin onset (DLMO) (time frame: the day directly before and after the intervention). The study lists 7 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 9 Oct 2026.