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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: Recruiting NA study of Opioid Use Disorder and Sleep, sponsored by University of Alabama at Birmingham.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE AYO light glasses (experimental)
- DEVICE AYO light glasses (comparator)
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2025-09-06 |
| Est. Completion | 2028-09-16 |
| Phase | NA |
What NCT06832007 shows while recruiting
NCT06832007 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 4,656-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06832007's enrollment target sits among peer trials
105 126th of 257 higher than 132 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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