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NCT06832007 · ClinicalTrials.gov registry record · NA

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

A NA study of Opioid Use Disorder and Sleep, sponsored by University of Alabama at Birmingham.

Recruiting
Registry status
NA
Development phase
105
Enrollment target
1
Study location

NCT06832007 is a NA study of Opioid Use Disorder and Sleep that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 105 participants, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06832007, a NA study of Opioid Use Disorder and Sleep, is actively recruiting participants, sponsored by University of Alabama at Birmingham.

RECRUITING
Registry status
NA
Development phase
105 participants
Enrollment target
1
Study location

Study 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 b

Interventions

  • DEVICE AYO light glasses (experimental)
  • DEVICE AYO light glasses (comparator)

Study Locations (1)

Alabama

  • University of Alabama at Birmingham - Birmingham

Trial Details

FieldValue
Enrollment Target 105 participants
Start Date 2025-09-06
Est. Completion 2028-09-16
Phase NA

Sponsor

University of Alabama at Birmingham

1,160 total trials

What the Registry Record Tells You About NCT06832007

The ClinicalTrials.gov registry entry for NCT06832007 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (98% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which AYO light glasses (experimental) is the first listed.

NCT06832007 reports 1 study location spanning 1 distinct geographic area - top geographies include Alabama.

Frequently Asked Questions

What is clinical trial NCT06832007 about?

NCT06832007 is a clinical study titled "The Effect of Light Intervention on Recovery in Individuals With Opioid Use Disorder (OUD)". 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 pharma...

What is the current status of trial NCT06832007?

This trial is currently recruiting. It is a NA study. The enrollment target is 105 participants. The study started on 2025-09-06. Estimated completion is 2028-09-16.

What conditions does trial NCT06832007 study?

This clinical trial studies the following conditions: Opioid Use Disorder, Sleep, Circadian Rhythms, fMRI Research.

What interventions are being tested in trial NCT06832007?

The interventions under investigation include: AYO light glasses (experimental) (DEVICE), AYO light glasses (comparator) (DEVICE).

Who is sponsoring clinical trial NCT06832007?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06832007 being conducted?

This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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