Sleep and Circadian Rhythm Assessments for Opioid Use Disorder

(MOUD Trial)

Overseen By Brionna Smith, B.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must be taking: Methadone, XR-NTX, Buprenorphine

Must not be taking: Illicit opioids, Stimulants, Benzodiazepines

Disqualifiers: Eye disease, Suicidal, Narcolepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be stable on your medication for opioid use disorder (no dose change) for the past month to participate.

What data supports the effectiveness of the treatment Multiple Sleep Latency Test, Polysomnography, Post-Illumination Pupillary Response (PIPR) for opioid use disorder?

Research shows that sleep problems are common in people with opioid use disorder, and treatments like methadone and buprenorphine can affect sleep patterns. Monitoring sleep with tools like wireless EEGs has been found useful in understanding sleep issues during opioid withdrawal, which suggests that assessing sleep and circadian rhythms could help improve treatment outcomes for opioid use disorder. ^{1 2 3 4 5}

Is the treatment for sleep and circadian rhythm assessments in opioid use disorder generally safe for humans?

The studies reviewed focus on sleep monitoring and treatments for opioid use disorder, but they do not provide specific safety data for the sleep and circadian rhythm assessments themselves. However, these assessments, like the Multiple Sleep Latency Test and Polysomnography, are commonly used in sleep studies and are generally considered safe for humans. ^{1 2 3 4 6}

How does this treatment for opioid use disorder differ from other treatments?

This treatment is unique because it uses a wireless EEG monitor to objectively assess sleep patterns in patients with opioid use disorder, providing precise measurements of sleep disturbances during opioid withdrawal, which is not typically addressed by standard opioid treatments like methadone or buprenorphine. ^{1 2 3 4 7}

What is the purpose of this trial?

Opioid use disorder (OUD) is a treatable medical illness with three medications FDA approved for treatment. However, persons with OUD report significant sleep disturbance, even when treated with medications for opioid use disorder, leading to high rates of relapse. In this project, we will investigate a special set of photosensitive neurons in the retina as an underlying mechanism for circadian rhythm and sleep disturbance from opioid use and medications for OUD that could lead to novel intervention and improve treatment outcomes.

Research Team

Karen Cropsey, Psy.D.

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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.

Inclusion Criteria

My drug screen was positive for buprenorphine or methadone, which were prescribed to me.

I am taking medication for opioid addiction or I am a healthy control.

Stable on MOUD (no dose change) for the past month

Exclusion Criteria

You have used illegal drugs or certain prescription drugs in the past month.

You have a severe alcohol or cannabis use problem, as determined by a checklist used by doctors.

I have a history of or currently have an eye condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MOUD therapy with methadone, buprenorphine, or extended-release naltrexone, and undergo assessments of ipRGC function, sleep, and circadian rhythms

6 months

Multiple visits for assessments and follow-ups

Follow-up

Participants are monitored for relapse and treatment outcomes, including self-reported drug cravings and withdrawal symptoms

6 months

Exploratory Assessment

10-day assessment of daily sleep-wake behavior and opioid craving/withdrawal symptoms in participants' normal environment

10 days

Treatment Details

Interventions

• Multiple Sleep Latency Test
• Polysomnography
• Post-Illumination Pupillary Response (PIPR)

Trial Overview 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).

Participant Groups

Group I: Non-opioid using controls Experimental Treatment 7 Interventions

non-opioid using controls

Group II: MOUD therapy methadone Experimental Treatment 7 Interventions

50 methadone participants

Group III: MOUD therapy extended-release naltrexone Experimental Treatment 7 Interventions

50 extended-release naltrexone (XR-NTX) participants

Group IV: MOUD therapy buprenorphine Experimental Treatment 7 Interventions

50 buprenorphine participants

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

In a study of 37 opioid-dependent participants receiving either methadone or buprenorphine, sleep duration and timing were significantly affected by drug use, with illicit opioid use leading to less sleep and later bedtimes.

The clinic hours for opioid agonist treatment (OAT) also influenced sleep patterns, as participants reported sleeping less and waking earlier when attending early morning clinic hours, indicating that clinic schedules can impact the sleep/wake cycles of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep reductions associated with illicit opioid use and clinic-hour changes during opioid agonist treatment for opioid dependence: Measurement by electronic diary and actigraphy. Bertz, JW., Epstein, DH., Reamer, D., et al.[2021]

A pilot study involving 8 male participants demonstrated that a wireless sleep EEG monitor (Sleep Profiler™) is a feasible tool for objectively measuring sleep outcomes during opioid withdrawal, with participants using it 85.6% of scheduled nights.

The wireless EEG provided more detailed insights into sleep architecture compared to self-reported sleep diaries, revealing significant associations between sleep quality and withdrawal severity, which could inform future treatment interventions for sleep issues in opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wireless electroencephalography (EEG) to monitor sleep among patients being withdrawn from opioids: Evidence of feasibility and utility. Dunn, KE., Finan, PH., Huhn, AS., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sleep reductions associated with illicit opioid use and clinic-hour changes during opioid agonist treatment for opioid dependence: Measurement by electronic diary and actigraphy. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Wireless electroencephalography (EEG) to monitor sleep among patients being withdrawn from opioids: Evidence of feasibility and utility. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Sleep-wake disorders in veterans with opioid use disorder: Prevalence and comorbidities. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Effects of methadone, buprenorphine, and naltrexone on actigraphy-based sleep-like parameters in male rhesus monkeys. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Sleep Health Among Adults in Outpatient Opioid Use Disorder Treatment: A Systematic Review. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Effects of chronic treatment with methadone and naltrexone on sleep in addicts. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Sleep and Rest-Activity Rhythms in Recovering Patients with Severe Concurrent Mental and Substance Use Disorder: A Pilot Study. [2023]