Recruiting

Bright Light Therapy

Sponsor:

University of Alabama at Birmingham

Code:

NCT06832007

Conditions

Opioid Use Disorder

Sleep

Circadian Rhythms

fMRI Research

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

AYO light glasses (experimental)

AYO light glasses (comparator)

Study Details

Brief 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. 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

Study ID

NCT06832007

Start date

Sep 6, 2025

Status verified date

Oct, 2025

Completion date

Sep 16, 2028

Anticipated

Primary completion date

Sep 16, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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

Study Design

Enrollment

105 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental light

MOUD participants

active comparator: Comparison light

MOUD participants

no intervention: Healthy control

Interventions

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.

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

Primary outcome measure

  • Dim light melatonin onset (DLMO) [ Time Frame: the day directly before and after the intervention ]
  • melatonin metabolites level [ Time Frame: the day directly before and after the intervention ]
  • Sleep-wake regularity [ Time Frame: From the enrollment to the end of the treatment at 24 days ]
  • Total sleep duration [ Time Frame: From the enrollment to the end of the treatment at 24 days; 2-3 nights per week ]
  • N3 sleep [ Time Frame: From the enrollment to the end of the treatment at 24 days; 2-3 nights per week ]
  • REM sleep [ Time Frame: From the enrollment to the end of the treatment at 24 days; 2-3 nights per week ]
  • sleep spindle [ Time Frame: From the enrollment to the end of the treatment at 24 days; 2-3 nights per week ]

Central Contacts and Locations

Central contacts

Rui Zhang, PhD

2059966170rzhang5@uab.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Rui Zhang

2059966170ruizhang@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Oct 20, 2025

Last verified

Oct, 2025

Keywords

  • opioid use disorder
  • sleep
  • circadian rhythms
  • fMRI research

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2025-10-20.