Status:
UNKNOWN
A Project to Test the Efficacy and Safety of An Innovative Treatment for Opiate Use Disorders.
Lead Sponsor:
MindLight, LLC
Collaborating Sponsors:
Mclean Hospital
Conditions:
Opioid Use Disorder, Moderate
Opioid Use
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Investigators will test, for safety and efficacy, a novel treatment for opiate addiction that applies a 4-minute treatment of intense near infra-red light to stimulate a side of the brain that the inv...
Detailed Description
Approach. Investigators have had a and productive Pre-submission meeting with the FDA on April 21, 2022, and are following their guidance in our approach. The goal of this Phase II study is to test fu...
Eligibility Criteria
Inclusion
- Male or non-pregnant females between 18-65 years of age
- Individuals having an opioid use disorder with mild-to-moderately severe symptoms
Exclusion
- 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.
Key Trial Info
Start Date :
January 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2024
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT05995873
Start Date
January 22 2024
End Date
August 30 2024
Last Update
March 26 2024
Active Locations (1)
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1
MindLight, LLC
Newton Highlands, Massachusetts, United States, 02461