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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-month follow up

Awards & highlights

MOUD Trial 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.Check my eligibility

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).See study design

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.

MOUD Trial 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.

MOUD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-month follow up

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Aim 1: Post-Illumination Pupillary Response (PIPR)

Aim 2: Polysomnography

Aim 3: Number of Participants Multiple Sleep Latency Test

+1 more

Secondary outcome measures

Dim Light Melatonin Onset (DLMO)

Melatonin suppression test

MOUD 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

~410

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,583 Previous Clinical Trials

2,279,844 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,465 Previous Clinical Trials

2,618,433 Total Patients Enrolled

Karen Cropsey, PsyDPrincipal InvestigatorUniversity of Alabama at Birmingham

2 Previous Clinical Trials

180 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial open to those aged fifty and over?

"Potential participants of this medical trial must not exceed 80 years old and should be at least 18."

Answered by AI

Are individuals being invited to join this research endeavor?

"As per clinicaltrials.gov, this research study is no longer enrolling patients. First posted on January 1st 2024 and most recently updated October 24th 2023; though it is currently dormant, there are 654 other trials actively recruiting participants at the present time."

Answered by AI

Who qualifies to partake in this experimental research study?

"Individuals who desire to take part in this trial should have a diagnosis of opioid use disorder, and they must be between the ages of 18-80. Approximately 200 individuals will eventually join the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment

Karen Cropsey 2024. "Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06104280.

All > Sleep Disorder > Melatonin