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Search / Trial NCT05995873

A Project to Test the Efficacy and Safety of An Innovative Treatment for Opiate Use Disorders.

Launched by MINDLIGHT, LLC · Aug 10, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people struggling with opioid addiction. The researchers want to see if a special type of light therapy, which involves shining near-infrared light on a specific part of the brain for just 4 minutes, can help those with mild to moderate symptoms of opioid use disorder. Participants in the trial will receive either the active treatment or a placebo (which looks like the real treatment but doesn't work) once or twice a week for 25 weeks. The goal is to find out if this approach is safe and effective in helping people overcome their addiction and to learn more about the connections between trauma and addiction.

To take part in this study, you need to be a male or non-pregnant female between the ages of 18 and 65 who is experiencing opioid use disorder with mild to moderate symptoms. However, individuals who are pregnant, have severe mental health issues, or are actively suicidal cannot participate. If you join the trial, you can expect to attend treatment sessions at one of the study sites and contribute to important research that could help others facing similar challenges in the future.

Gender

ALL

Eligibility 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.

About Mindlight, Llc

Mindlight, LLC is a pioneering clinical trial sponsor dedicated to advancing mental health treatments through innovative research and technology. With a focus on developing evidence-based therapeutic solutions, Mindlight leverages cutting-edge neuroscience and data analytics to enhance patient outcomes in the realm of mental health. The organization collaborates with healthcare professionals, researchers, and regulatory bodies to conduct rigorous clinical trials that aim to transform the understanding and management of mental health disorders. By prioritizing patient safety and scientific integrity, Mindlight is committed to delivering impactful therapies that improve the quality of life for individuals affected by mental health challenges.

Locations

Newton Highlands, Massachusetts, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported