23 Participants Needed

Bright Light Therapy for Opioid Use Disorder

CJ
NW
Overseen ByNina Winsick, M.S.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Arizona State University
Must be taking: Methadone, Buprenorphine

What You Need to Know Before You Apply

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.12345

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.23567

Who Is on the Research Team?

CJ

Chung Jung Mun, Ph.D.

Principal Investigator

Arizona State University

Are You a Good Fit for This Trial?

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
See 3 more

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
See 8 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bright light therapy groupExperimental Treatment1 Intervention
Group II: Dim light (placebo) groupPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials
311
Recruited
109,000+

Published Research Related to This Trial

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.
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.
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.
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]

Citations

A Prescription Digital Therapeutic to Support Unsupervised Buprenorphine Initiation for Patients With Opioid Use Disorder: Protocol for a Proof-of-Concept Study. [2023]
Real-world evidence for a prescription digital therapeutic to treat opioid use disorder. [2021]
Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. [2021]
Clinical Trial Design Challenges and Opportunities for Emerging Treatments for Opioid Use Disorder: A Review. [2023]
An Effective and Safe Novel Treatment of Opioid Use Disorder: Unilateral Transcranial Photobiomodulation. [2023]
Real-world use and clinical outcomes after 24 weeks of treatment with a prescription digital therapeutic for opioid use disorder. [2022]
Comparison of Healthcare Resource Utilization Between Patients Who Engaged or Did Not Engage With a Prescription Digital Therapeutic for Opioid Use Disorder. [2022]
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