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Sleep and Circadian Rhythm Assessments for Opioid Use Disorder (MOUD Trial)

N/A
Waitlist Available
Led By Karen Cropsey, PsyD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Positive on urine drug screen (UDS) for buprenorphine or methadone if prescribed those medications
Prescribed one of three medications for opioid use disorder (methadone, XR-NTX, buprenorphine) or healthy control
Must not have
Eye disease reported by history or noted on exam 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
Persons diagnosed with narcolepsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-month follow up
Awards & highlights
No Placebo-Only Group

Summary

This trial will explore how OUD affects sleep and how new treatments may help. Treatments will target special photosensitive neurons in the eye.

Who is the study for?
This trial is for adults over 18 who are on stable doses of FDA-approved medications for opioid use disorder, such as methadone, XR-NTX, or buprenorphine. Participants must have a positive drug screen if prescribed these medications but cannot be using illicit opioids or other drugs like stimulants and benzodiazepines.
What is being tested?
The study examines how certain neurons in the retina might affect sleep and circadian rhythms in people with opioid use disorder. It involves tests like sleep latency measurement, pupil response tracking after light exposure, momentary assessments during daily life activities, overnight sleep monitoring (polysomnography), melatonin suppression testing, activity tracking (actigraphy), and timing of melatonin onset in saliva (DLMO).
What are the potential side effects?
Since this trial focuses on assessments rather than medication administration to participants already taking their prescribed opioid treatment medications, it does not introduce new side effects beyond those possibly associated with the existing treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My drug screen was positive for buprenorphine or methadone, which were prescribed to me.
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I am taking medication for opioid addiction or I am a healthy control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of or currently have an eye condition.
Select...
I have been diagnosed with narcolepsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-month follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-month follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Aim 1: Post-Illumination Pupillary Response (PIPR)
Aim 2: Polysomnography
Aim 3: Number of Participants Multiple Sleep Latency Test
+1 more
Secondary study objectives
Dim Light Melatonin Onset (DLMO)
Melatonin suppression test

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Non-opioid using controlsExperimental Treatment7 Interventions
non-opioid using controls
Group II: MOUD therapy methadoneExperimental Treatment7 Interventions
50 methadone participants
Group III: MOUD therapy extended-release naltrexoneExperimental Treatment7 Interventions
50 extended-release naltrexone (XR-NTX) participants
Group IV: MOUD therapy buprenorphineExperimental Treatment7 Interventions
50 buprenorphine participants
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Actigraphy
2016
N/A
~430

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,573 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,586 Previous Clinical Trials
3,328,330 Total Patients Enrolled
Karen Cropsey, PsyDPrincipal InvestigatorUniversity of Alabama at Birmingham
2 Previous Clinical Trials
180 Total Patients Enrolled
~133 spots leftby Dec 2028
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