Light Intervention for Opioid Use Disorder (OUD) Recovery

This study is exploring whether light therapy can help people with Opioid Use Disorder (OUD) improve their sleep and overall recovery. Many individuals with OUD experience sleep problems, which can make recovery harder. This research aims to see if using AYO light glasses, which deliver a specific type of light, can help regulate sleep patterns. You would wear these glasses for 30 minutes each morning for two weeks. The study will compare a group using the full-intensity AYO light glasses to a group using the same glasses at a lower intensity. Researchers will measure changes in your melatonin levels (a hormone that helps with sleep) and how regular your sleep-wake cycle is. To join, you need to be between 18 and 60 years old, fluent in English, and have an OUD diagnosis, receiving stable opioid agonist therapy (like methadone or buprenorphine). The current status of this study is unclear, and it plans to enroll 105 participants.

Study design
This is an interventional study comparing two groups using AYO light glasses. It plans to enroll 105 participants.
What's involved
You would wear AYO light glasses for 30 minutes each morning for two weeks. Researchers will measure your melatonin levels before and after the intervention, and track your sleep-wake regularity for 24 days.
Compensation
Not stated in the trial record.
Follow-up
Your sleep-wake regularity will be measured from enrollment to the end of the treatment at 24 days.

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NCT06832007

The Effect of Light Intervention on Recovery in Individuals With Opioid Use Disorder (OUD)

Recruiting
NAAges 18–60InterventionalTreatment
University of Alabama at Birmingham
~105 participants
Updated 2025-10-20 on ClinicalTrials.gov
What's tested:AYO light glasses (experimental)AYO light glasses (comparator)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dim light melatonin onset (DLMO)
Measured over the day directly before and after the intervention
+6 more outcomes measured
Opioid Use Disorder
Sleep
Circadian Rhythms
fMRI Research
1 sites across 1 states
Alabama1

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Eligibility criteria

Inclusion

All Participants
Between 18 and 60 years old
Fluent in English
Able to provide written informed consent
DSM-5 diagnosis of an OUD.
≥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.

Exclusion

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
History of eye surgery
Chronic migraine triggered by bright light
worked night shift or traveled across\>2 time zones in the past month
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)
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
  • Dim light melatonin onset (DLMO)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 levelthe 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 regularityFrom 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 durationFrom 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 sleepFrom 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 sleepFrom 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 spindleFrom 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.