Clinical trial NCT06832007: The Effect of Light Intervention on Recovery in Individuals with Opioid Use Disorder (OUD)
Official title: The Effect of Light Intervention on Recovery in Individuals with Opioid Use Disorder (OUD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Sleep
Circadian Rhythms
FMRI Research
Keywords: opioid use disorder
sleep
circadian rhythms
fMRI research
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Dim light melatonin onset (DLMO)
timeFrame: the day directly before and after the intervention
measure: melatonin metabolites level
timeFrame: the day directly before and after the intervention
measure: Sleep-wake regularity
timeFrame: From the enrollment to the end of the treatment at 24 days
measure: sleep architecture
timeFrame: From the enrollment to the end of the treatment at 24 days; 2-3 nights per week
Secondary outcomes:
measure: brain signiture of craving measured by cue reactivity task
timeFrame: the day prior to the intervention and the day after the intervention
measure: brain functions during resting state
timeFrame: the day before and after light intervention
measure: Ecological momentary assessment (EMA)
timeFrame: From the enrollment to the end of the treatment at 24 days
Other outcomes:
measure: post-illumination pupil response
timeFrame: study visit prior to the treatment
Locations:
city: Birmingham
country: United States
facility: Rui Zhang
state: Alabama
Study officials:
References: