Bright Light Therapy for Opioid Use Disorder

Overseen By Nina Winsick, M.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Arizona State University

Must be taking: Methadone, Buprenorphine

Must not be taking: Photosensitizing, Melatonin

Disqualifiers: Bipolar, Narcolepsy, Seizures, Sleep apnea, others

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

23 Participants Needed

Trial Summary

What is the purpose of this trial?

Investigators propose to conduct a pilot single-blind, parallel arm, randomized placebo-controlled trial evaluating the feasibility, acceptability, and preliminary efficacy of bright light therapy on reward system functioning among patients undergoing medication-assisted treatment for opioid use disorder.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you must be on a stable dose of methadone or buprenorphine for at least one month. You cannot participate if you are taking photosensitizing medications or regularly using melatonin.

Is bright light therapy safe for humans?

In a study evaluating a similar light-based treatment for opioid use disorder, no adverse effects were reported, suggesting it is generally safe for humans. ^{1 2 3 4 5}

How does bright light therapy differ from other treatments for opioid use disorder?

Bright light therapy is unique because it uses light exposure to potentially influence brain activity and reduce opioid cravings, unlike traditional treatments that often involve medication or behavioral therapy. This approach is non-invasive and focuses on altering brain function through light, which is different from the chemical interventions used in medication-assisted treatments. ^{2 3 5 6 7}

Research Team

Chung Jung Mun, Ph.D.

Principal Investigator

Arizona State University

Eligibility Criteria

This trial is for English-speaking adults aged 18-65 with opioid use disorder who are in outpatient treatment, have had stable medication doses for a month, and suffer from insomnia. They must own a smartphone. People with bipolar disorder, high risk of sleep apnea, eye conditions or surgeries, certain medication usage, recent night shift work or travel outside Arizona time zone can't participate.

Inclusion Criteria

I have been on a stable dose of methadone or buprenorphine for at least one month.

Been in medication-assisted treatment for at least 3 months

Ability to speak, write, and read in English

Exclusion Criteria

Currently wearing prescription glasses with blue-light protection

I have narcolepsy, sleep paralysis, or restless leg syndrome.

The STOP-Bang score for obstructive sleep apnea ≥ 5

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Baseline Assessment

Participants undergo baseline sleep assessment to determine average wake time

1 week

Treatment

Participants receive 30-minute morning bright light or dim light therapy for 2 weeks

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Wearable bright light therapy device
• Wearable placebo light therapy device

Trial Overview The study tests the effects of bright light therapy using wearable devices on patients' reward system functioning during opioid addiction treatment. Participants will be randomly assigned to either real bright light therapy or a placebo device without knowing which one they receive.

Participant Groups

Group I: Bright light therapy group Experimental Treatment 1 Intervention

Participants will receive 30-minute morning bright light therapy for 2 weeks. Participants will start the therapy within a few minutes of their designated wake up time, which is determined by their average wake time from the baseline week of sleep assessment.

Group II: Dim light (placebo) group Placebo Group 1 Intervention

Participants will receive 30-minute dim light (placebo) therapy for 2 weeks. Participants will start the therapy within a few minutes of their designated wake up time, which is determined by their average wake time from the baseline week of sleep assessment.

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

Findings from Research

The pilot study is evaluating the acceptability and effectiveness of a new digital therapeutic (PEAR-002b) designed to assist individuals with opioid use disorder (OUD) in initiating buprenorphine treatment at home, which is considered safe and effective.

The study aims to measure the success rate of unsupervised buprenorphine initiation, medication adherence, and participant satisfaction, using tools like PEAR-002b and reSET-O, with outcomes assessed through participant interviews, satisfaction surveys, and urine drug screenings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prescription Digital Therapeutic to Support Unsupervised Buprenorphine Initiation for Patients With Opioid Use Disorder: Protocol for a Proof-of-Concept Study. Luderer, H., Enman, N., Gerwien, R., et al.[2023]

In a study of 3144 patients with opioid use disorder, the prescription digital therapeutic (PDT) reSET-O showed high engagement, with 80% of patients completing at least 8 out of 67 therapeutic modules, which is linked to improved treatment outcomes.

Patients who engaged with reSET-O demonstrated significant abstinence rates, with 66% abstinent in the last 4 weeks of treatment and 91% meeting the responder definition, indicating that this digital tool can effectively support traditional buprenorphine therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world evidence for a prescription digital therapeutic to treat opioid use disorder. Maricich, YA., Xiong, X., Gerwien, R., et al.[2021]

A pilot study involving 26 adults with opioid use disorder (OUD) showed that using the mobile app 'uMAT-R' significantly increased interest in treatment from 32% to 48%.

Participants also reported improved attitudes towards medication-assisted treatment (MAT), with 88% believing the app would be helpful in making recovery decisions, indicating its potential as a supportive tool in addressing the opioid epidemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. Cavazos-Rehg, PA., Krauss, MJ., Costello, SJ., et al.[2021]

This review emphasizes the need for novel treatments for opioid use disorder (OUD) that target mechanisms beyond the traditional μ-opioid receptor system, highlighting the importance of innovative clinical trial designs for these emerging therapies.

Key recommendations for trial design include focusing on specific treatment stages, defining the role of new treatments in relation to existing therapies, and prioritizing patient-centered outcomes, while also monitoring for adverse events like relapse or overdose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Trial Design Challenges and Opportunities for Emerging Treatments for Opioid Use Disorder: A Review. Kiluk, BD., Kleykamp, BA., Comer, SD., et al.[2023]

In a randomized controlled trial involving 39 participants, unilateral transcranial photobiomodulation significantly reduced opioid cravings and use compared to a sham treatment, with a notable effect size of 1.5 for cravings at the last follow-up.

The treatment was effective for both participants on buprenorphine and those not on it, and importantly, no adverse effects were reported, indicating a safe profile for this novel intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Effective and Safe Novel Treatment of Opioid Use Disorder: Unilateral Transcranial Photobiomodulation. Schiffer, F., Khan, A., Bolger, E., et al.[2023]

In a study of 3,817 patients with opioid use disorder (OUD), those who received a second 12-week prescription of the reSET-O digital therapeutic showed an 86% abstinence rate from opioids in the last month of treatment, indicating high efficacy in reducing substance use.

Patients who completed the 24-week treatment had a 27% reduction in hospital encounters compared to those who only received the initial 12-week prescription, demonstrating improved clinical outcomes and retention in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world use and clinical outcomes after 24 weeks of treatment with a prescription digital therapeutic for opioid use disorder. Maricich, YA., Gerwien, R., Kuo, A., et al.[2022]

Patients with opioid use disorder (OUD) who engaged with the prescription digital therapeutic reSET-O® experienced a significant cost reduction of $2708 per patient over 9 months compared to those who did not engage with the therapy, despite similar adherence to buprenorphine treatment.

The study involved a retrospective analysis of 444 patients who engaged with reSET-O and 64 non-engaged patients, showing that engaging with the digital therapeutic led to lower healthcare resource utilization and costs for both inpatient and outpatient services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Healthcare Resource Utilization Between Patients Who Engaged or Did Not Engage With a Prescription Digital Therapeutic for Opioid Use Disorder. Velez, FF., Colman, S., Kauffman, L., et al.[2022]

References

1. Canada pubmed.ncbi.nlm.nih.gov

A Prescription Digital Therapeutic to Support Unsupervised Buprenorphine Initiation for Patients With Opioid Use Disorder: Protocol for a Proof-of-Concept Study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Real-world evidence for a prescription digital therapeutic to treat opioid use disorder. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. [2021]

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

Clinical Trial Design Challenges and Opportunities for Emerging Treatments for Opioid Use Disorder: A Review. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

An Effective and Safe Novel Treatment of Opioid Use Disorder: Unilateral Transcranial Photobiomodulation. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Real-world use and clinical outcomes after 24 weeks of treatment with a prescription digital therapeutic for opioid use disorder. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Comparison of Healthcare Resource Utilization Between Patients Who Engaged or Did Not Engage With a Prescription Digital Therapeutic for Opioid Use Disorder. [2022]