Light Therapy for Opioid Use Disorder

Overseen By Rui Zhang, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must be taking: Opioid agonists

Must not be taking: Unstable psychiatric meds

Disqualifiers: Seizures, Pregnancy, Eye disease, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

105 Participants Needed

Trial Summary

What is the purpose of this trial?

Opioid use disorder (OUD) is a chronic relapsing disorder and is well-known for its high-risk rate of overdoses and death. In OUD, sleep and circadian disruptions are highly prevalent, interfere with opioid maintenance treatment outcomes and increase the risk of relapse. So far, commonly used pharmacological sleep treatments fail to improve sleep or decrease illicit drug use in OUD. Thus, there is an urgent need to fill this research gap. Previous work showed that OUD patients who were receiving opioid agonist treatment (MOUD+) exhibited greater irregularity of sleep-wake cycle. In OUD patients, sleep-wake irregularity was associated with years of heroin use and low light exposure. Bright light therapy (BLT) is a very promising circadian/sleep intervention for several sleep, psychiatric and neurological disorders. BLT improved circadian, sleep outcomes and negative mood. In a pilot study, BLT improved objective and subjective sleep in patients with alcohol use disorder. Here investigators proposed an intervention study for MOUD+ patients to determine effects of BLT as an adjunct treatment on sleep and circadian outcomes including endogenous circadian rhythm, rest-activity rhythm and sleep neurophysiology (Primary objectives); and to determine effects of BLT on brain function and on clinical outcomes including negative affect, craving and illicit drug use and whether changes in sleep and circadian rhythm mediate the BLT effect on brain recovery and clinical outcomes (Secondary objectives). Fifty MOUD+ will be assigned either to bright light or to dim light group for 2 weeks. The groups will be matched for age, sex, race and OUD medication (Methadone vs Buprenorphine). The study will run throughout the year such that it occurs during all seasons. Light exposure will be measured with light sensor for additional control. All MOUD+ participants will have a daily 30-min light exposure (bright or dim blue light) in the morning after their habitual wake-up time and will be asked to avoid evening light before bed. Dim light melatonin onset, accelerometer, sleep EEG and questionnaires will be used to measure objective and subjective sleep and circadian outcomes. For brain function, cue-reactivity task will be used to assess brain activation during drug craving. Resting state functional connectivity and brain state dynamics will be assessed by rsfMRI. Mood, opiate craving and illicit drug use will be assessed. All measures will be repeated before and after the treatment. Investigators expect that BLT would normalize sleep and circadian outcomes, attenuate impairments in brain functions and result in better clinical outcomes. If successful, light therapy will provide add-on benefits to opioid agonist therapy and facilitate OUD recovery process.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that your opioid treatment dose is stable for the past month. Psychiatric medications like sleep aids and antidepressants must also be stable for 30 days before and during the study.

What data supports the effectiveness of the AYO light glasses treatment for opioid use disorder?

Research on a similar light-based treatment, unilateral transcranial photobiomodulation, showed significant reductions in opioid cravings and use compared to a placebo, with no adverse effects reported. This suggests that light therapy could be a promising approach for treating opioid use disorder. ^{1 2 3 4 5}

Is light therapy safe for treating opioid use disorder?

In a study using light therapy for opioid use disorder, no adverse effects were reported, suggesting it is generally safe for humans. ^{1 2 3 5 6}

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

Light therapy, specifically unilateral transcranial photobiomodulation, is unique because it uses a light-emitting diode applied to the forehead to reduce opioid cravings by targeting the brain hemisphere with a more positive emotional state. This non-invasive approach differs from traditional treatments like medication or psychotherapy by focusing on altering brain activity through light exposure. ^{1 3 5 7 8}

Eligibility Criteria

This trial is for individuals with Opioid Use Disorder who are currently on opioid agonist treatment. Participants should be willing to wear AYO light glasses daily and avoid evening light before bed. The study seeks a diverse group matched by age, sex, race, and medication type.

Inclusion Criteria

* All Participants

* Fluent in English

* Able to provide written informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily 30-min light exposure (bright or dim blue light) for 2 weeks

2 weeks

Daily sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AYO light glasses

Trial Overview The study tests if bright light therapy using AYO glasses can improve sleep and circadian rhythms in people with OUD as an add-on to their current treatment. It compares the effects of bright vs dim blue light exposure every morning for two weeks.

Participant Groups

Group I: Experimental light Experimental Treatment 1 Intervention

MOUD participants

Group II: Comparison light Active Control 1 Intervention

MOUD participants

Group III: Healthy control Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

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]

A novel treatment using unilateral transcranial photobiomodulation (t-PBM) significantly reduced opioid cravings by 51% one week after treatment, compared to only 15.8% reduction from a sham treatment, indicating its efficacy in addressing opioid use disorders.

The active t-PBM treatment also led to significant improvements in depression and anxiety scores, demonstrating its potential as a safe and effective intervention for individuals with opioid cravings and related mental health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Treatment of Opioid Cravings With an Effect Size of .73 for Unilateral Transcranial Photobiomodulation Over Sham. Schiffer, F., Reichmann, W., Flynn, E., et al.[2022]

Long-term opioid agonist therapy with methadone and buprenorphine has been shown to be highly effective in treating opioid use disorder (OUD), significantly reducing the risk of relapse and saving lives.

Despite the effectiveness of these treatments, the delivery of prevention and treatment for OUD is often hindered by coexisting health issues, lack of support, and varying public opinions, highlighting the need for better scientific communication and evidence-based strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid use disorder. Strang, J., Volkow, ND., Degenhardt, L., et al.[2021]

A pilot study involving three patients with long-standing opioid dependency showed that treatment with a high-intensity cold laser device allowed them to discontinue all opioid medications after 8-12 sessions over 3-4 weeks.

At follow-up 1-2 months later, these patients reported effective pain control using only over-the-counter non-opioid analgesics, suggesting that this non-pharmacologic approach may be a promising alternative for managing chronic pain and reducing opioid dependency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel treatment for chronic opioid use after surgery. White, PF., Elvir-Lazo, OL., Hernandez, H.[2018]

A study involving 1,107 individuals with opioid use disorder showed that engaging with the computer-assisted therapy program 'Breaking Free Online' led to significant reductions in opioid use and improvements in biopsychosocial functioning, with effect sizes ranging from 0.15 to 0.50.

Participants with greater baseline clinical impairment experienced more substantial improvements post-treatment, suggesting that CAT could be particularly beneficial for those with more complex psychosocial issues when combined with medications for opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between baseline opioid use disorder severity, mental health and biopsychosocial functioning, with clinical responses to computer-assisted therapy treatment. Elison-Davies, S., Märtens, K., Yau, C., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

2. 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]

3. Switzerland pubmed.ncbi.nlm.nih.gov

A Novel Treatment of Opioid Cravings With an Effect Size of .73 for Unilateral Transcranial Photobiomodulation Over Sham. [2022]

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

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

5. England pubmed.ncbi.nlm.nih.gov

Opioid use disorder. [2021]

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

Poor Sleep Quality and Other Risk Factors for Unemployment Among Patients on Opioid Agonist Treatment. [2022]

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

A novel treatment for chronic opioid use after surgery. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Associations between baseline opioid use disorder severity, mental health and biopsychosocial functioning, with clinical responses to computer-assisted therapy treatment. [2021]