~70 spots leftby May 2028

Light Therapy for Opioid Use Disorder

Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University of Alabama at Birmingham
Stay on Your Current Meds
No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for individuals with Opioid Use Disorder who are currently on opioid agonist treatment. Participants should be willing to wear AYO light glasses daily and avoid evening light before bed. The study seeks a diverse group matched by age, sex, race, and medication type.

Inclusion Criteria

* All Participants
* Between 18 and 60 years old
* Fluent in English
See 7 more

Treatment Details

Interventions

  • AYO light glasses (Behavioural Intervention)
Trial OverviewThe study tests if bright light therapy using AYO glasses can improve sleep and circadian rhythms in people with OUD as an add-on to their current treatment. It compares the effects of bright vs dim blue light exposure every morning for two weeks.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Experimental lightExperimental Treatment1 Intervention
MOUD participants
Group II: Comparison lightActive Control1 Intervention
MOUD participants
Group III: Healthy controlActive Control1 Intervention

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
Rui ZhangBirmingham, AL
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Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1677
Patients Recruited
2,458,000+