Light Therapy for Opioid Use Disorder

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether light therapy can help individuals with opioid use disorder (OUD) improve sleep and reduce drug cravings. Participants will use special light glasses (AYO light glasses) each morning, which may regulate sleep patterns and mood. The study compares bright light therapy with dim light to determine which is more effective. Individuals who have received stable opioid treatment, such as methadone or buprenorphine, and have used opioids for over a year might be suitable candidates. If successful, this treatment could complement existing opioid therapies. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for OUD.

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 prior data suggests that this light therapy is safe for opioid use disorder patients?

Research has shown that AYO light therapy glasses are generally safe to use. Important safety organizations, the FCC and CE, have approved them. The glasses emit a safe type of blue-enriched white light and do not produce harmful ultraviolet (UV) or infrared (IR) rays. Previous studies found no evidence of eye damage when these glasses are used correctly. This indicates they are well-tolerated and do not cause significant side effects in healthy individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about AYO light glasses for opioid use disorder because they offer a unique approach compared to traditional treatments like medications and behavioral therapies. Unlike standard options that typically involve pharmaceuticals or counseling, AYO light glasses use light therapy to potentially influence the brain's natural chemical balance, aiming to reduce cravings and withdrawal symptoms. This method provides a non-invasive and drug-free alternative, which could be particularly appealing for individuals seeking new ways to manage their recovery.

What evidence suggests that bright light therapy is effective for opioid use disorder?

This trial will compare the effects of different light therapies on individuals with opioid use disorder (OUD). Studies have shown that bright light therapy (BLT) can improve sleep and reset the body's internal clock in people with OUD. Research also indicates that BLT can lift mood and reduce cravings, common in OUD. Early findings suggest that BLT positively affects brain function and decreases the use of illegal drugs. In a small study, BLT improved sleep in people with alcohol use disorder, suggesting it might offer similar benefits for those with OUD. This evidence supports the potential effectiveness of BLT as an additional treatment for those undergoing opioid maintenance therapy. Participants in this trial will receive either an experimental light therapy or a comparison light therapy to evaluate these effects. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06832007?cond=sleep&aggFilters=status%3Arec

The Effect of Light Intervention on Recovery in Individuals ... Previous work showed that OUD patients who were receiving opioid agonist treatment (MOUD+) exhibited greater irregularity of sleep-wake cycle. In OUD patients, ...

2. withpower.com withpower.com/trial/phase-sleep-4-2025-0083c

Light Therapy for Opioid Use Disorder 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 ...

3. trialx.com trialx.com/clinical-trials/listings/325274/the-effect-of-light-intervention-on-recovery-in-individuals-with-opioid-use-disorder-oud/

The Effect of Light Intervention on Recovery in Individuals ... Investigators expect that BLT would normalize sleep and circadian outcomes, attenuate impairments in brain functions and result in better ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9608534/

Series of virtual light therapy interventions for fatigue The current study evaluates the feasibility, acceptability and effectiveness of a series of N-of-1 interventions for virtual delivery of BL ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05459922

Adjunctive Bright Light Therapy for Opioid Use Disorder Bright light therapy (BLT) is a simple, safe, and accessible intervention that can effectively ameliorates sleep disruptions, as well as circadian misalignment ...

6. goayo.com goayo.com/blog/are-ayo-light-therapy-glasses-safe-to-use/

Are AYO light therapy glasses safe to use? Discover the safety features of AYO light therapy glasses: "no risk" device, FCC and CE certified, emit safe blue-enriched white light, UV and IR-free.

7. goayo.com goayo.com/blog/are-light-therapy-glasses-safe-what-science-reveals/

Are Light Therapy Glasses Safe? [What Science Reveals] Light therapy glasses are generally safe for healthy individuals, with studies showing no evidence of ocular damage when used properly.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12518755/

Korean Clinical Practice Guideline of Korean Society for ... In addition, this guideline is expected to support healthcare providers in improving cessation success rates and contribute to the reduction of smoking-related ...