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

Not Applicable

Not yet recruiting

• Conditions: Opioid Use Disorder; Sleep; Circadian Rhythms; FMRI Research

• Registration Number: NCT06832007
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Study First Posted: 2025-02-18
• Last Update Posted: 2025-02-18
• Study Start: 2025-05-01
• Primary Completion: 2028-05-01
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 105

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 level	the 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 regularity	From 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.
sleep architecture	From the enrollment to the end of the treatment at 24 days; 2-3 nights per week	N3, REM, sleep spindle and total sleep duration will be measured by sleep EEG. Participants will be asked to wear a wireless sleep monitor device during sleep in their home environment.

Secondary Outcome Measures

Name	Time	Method
brain signiture of craving measured by cue reactivity task	the day prior to the intervention and the day after the intervention	Participants will passively view neutral, food and opioid related pictures. Brain activity during the picture viewing will be captured.
brain functions during resting state	the day before and after light intervention	resting state fMRI data will be collected over an 8-min period of time. Brain functional connectivity and brain state transitions will be calculated
Ecological momentary assessment (EMA)	From the enrollment to the end of the treatment at 24 days	self-reported mood, opioid craving, withdrawal symptoms and illicit drug use will be captured by EMA surveys. The MetricWire platform will be utilized for EMA surveys. Sleep-related questions will be prompted within 1 hour of the participant's habitual wake-up time. For the OUD group, additional questions will include prior day's illicit drug use and the usage of buprenorphine and methadone (time and dose). Light therapy-related questions, including onset and offset times, adverse effects, and changes in positive and negative mood after the daily therapy session, will be collected before 1 pm. Questions on mood, craving, and pain severity will be delivered at six semi-random timepoints each day during the participant's waking hours.

Trial Locations

Locations (1)

Rui Zhang; 🇺🇸 Birmingham, Alabama, United States