Testing a new treatment for opioid addiction using light therapy
A Project to Test the Efficacy and Safety of An Innovative Treatment for Opiate Use Disorders.
This study is testing a new light therapy treatment for people with opioid addiction to see if it can help reduce cravings and improve their recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | MindLight, LLC Industry-sponsored |
| Locations | 1 site (Newton Highlands, Massachusetts) |
| Trial ID | NCT05995873 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the safety and efficacy of a novel treatment for opioid use disorder that utilizes a 4-minute application of intense near infra-red light to stimulate a healthier side of the brain. Participants will receive either the active treatment or a sham treatment once or twice weekly for 25 weeks across two sites. The study will assess the impact of this treatment on opioid use, cravings, and retention in therapy, with the goal of providing insights into the relationship between trauma, brain function, and addiction. The approach follows FDA guidance and seeks to achieve FDA clearance for the innovative therapy.
Who should consider this trial
Good fit: Ideal candidates are males or non-pregnant females aged 18-65 with mild-to-moderately severe opioid use disorder.
Not a fit: Patients who are pregnant, psychotic, actively suicidal, or have severe psychiatric or neurological disorders will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, non-invasive option for individuals struggling with opioid addiction.
How similar studies have performed: While this approach is innovative, similar studies using light therapy for other conditions have shown promise, but this specific application for opioid use disorder is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or non-pregnant females between 18-65 years of age * Individuals having an opioid use disorder with mild-to-moderately severe symptoms Exclusion Criteria: * Individuals who are pregnant, * Individuals who are psychotic, * Individuals who are actively suicidal, * Individuals who are a danger to self or others, * Individuals who are who have a history of severe psychiatric or neurological disorders or life-threatening medical illness. * Individuals will be excluded with chronic pain requiring opioid treatment. * Individuals who are who are breastfeeding, * Individuals who are adults requiring a legally authorized representative.
Where this trial is running
Newton Highlands, Massachusetts
- MindLight, LLC — Newton Highlands, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Fredric Schiffer, MD
- Email: fred.schiffermd@gmail.com
- Phone: 781-405-8800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.