Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT06832007

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

Led by University of Alabama at Birmingham · Updated on 2025-10-20

105

Participants Needed

1

Research Sites

158 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Between 18 and 60 years old
  • Fluent in English
  • Able to provide written informed consent
  • Diagnosed with opioid use disorder (OUD) according to DSM-5
  • At least 12 months of lifetime opioid use
  • Positive urine screen for buprenorphine or methadone
  • Receiving stable opioid agonist therapy (methadone or buprenorphine) for at least one month
  • Other substance use allowed if opioids are the primary substance
Not Eligible

You will not qualify if you...

  • History of head trauma with loss of consciousness over 30 minutes
  • History of seizures or epilepsy
  • Pregnant or currently breastfeeding
  • Presence of ferromagnetic objects in body or fear of enclosed spaces preventing MRI
  • Eye diseases including cataracts, glaucoma, retinopathy, or history of eye surgery
  • Chronic migraine triggered by bright light
  • Worked night shifts or traveled across more than 2 time zones in past month
  • Primary diagnosis of substance use disorder other than opioids
  • Lifetime diagnosis of schizophrenia, bipolar disorder, or suicidality
  • Prior light therapy treatment
  • Unstable psychiatric medication doses
  • For healthy controls: any current or past psychiatric disorder or sleep-wake disorder including insomnia

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Actively Recruiting

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Research Team

R

Rui Zhang, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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