Daily bright-light glasses to improve sleep and recovery in people with opioid use disorder
The Effect of Light Intervention on Recovery in Individuals With Opioid Use Disorder (OUD)
This trial will test whether wearing AYO bright-light glasses each morning can improve sleep patterns and support recovery in adults receiving medication for opioid use disorder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06832007 on ClinicalTrials.gov |
What this trial studies
Adults with opioid use disorder who are stabilized on methadone or buprenorphine will be assigned to use AYO light glasses or a comparator AYO device and followed over a treatment period. The study collects both objective and subjective sleep measures and monitors circadian regularity and mood. Brain imaging (fMRI) is included as part of the research assessments to explore neural correlates. Outcomes will be compared between the AYO intervention and comparator groups to see if morning bright-light exposure improves sleep and related recovery measures.
Who should consider this trial
Good fit: Adults aged 18–60 with DSM-5 opioid use disorder who have used opioids for at least 12 months, are stabilized on methadone or buprenorphine (positive urine for these medications) with a stable dose for at least one month, fluent in English, and able to consent.
Not a fit: People not on opioid agonist therapy, those with unstable dosing or medical exclusions such as a history of prolonged loss of consciousness, seizures, pregnancy, or ferromagnetic implants that preclude MRI, and those outside the age range are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, the intervention could improve sleep regularity and mood and potentially lower relapse risk for people on opioid agonist therapy.
How similar studies have performed: Bright light therapy has improved circadian and sleep outcomes in several psychiatric and neurological conditions and a pilot study showed better sleep in people with alcohol use disorder, but its effectiveness specifically in opioid use disorder remains limited and relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All Participants * Between 18 and 60 years old * Fluent in English * Able to provide written informed consent OUD * 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 Criteria: 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 * 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
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Study coordinator: Rui Zhang, PhD
- Email: rzhang5@uab.edu
- Phone: 2059966170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.