Status:
COMPLETED
Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders
Lead Sponsor:
MindLight, LLC
Collaborating Sponsors:
Mclean Hospital
Harvard Medical School (HMS and HSDM)
Conditions:
Opioid-use Disorder
Opioid Dependence
Eligibility:
All Genders
18-70 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
This project is to demonstrate that a novel treatment for opiate addiction is safe and far superior to a sham comparison treatment. The treatment is hoped to significantly aid in the battle against th...
Eligibility Criteria
Inclusion
- all patients must between the ages of 18 and 70
- meet criterion for a history of Opioid Use Disorder (OUD) on a Diagnostic Interview.
- have opioid cravings
- Enrollment will be made without regard to gender or ethnicity.
- Patients who are receiving treatment for OUD or other psychiatric disorders, either psychological or pharmacological treatments, may continue their treatment during the time of the study but will be asked to try not to alter their treatment from the onset of the experiment until its conclusion. The statistical analysis will include covariates for doses of buprenorphine and methadone and use of non-prescribed opioids
Exclusion
- past history of a psychotic disorder (including schizophrenia or schizoaffective disorder)
- history of violent behavior
- history of a past suicide gesture or attempt, a history of current suicidal ideation, \*history of a neurological condition (e.g. epilepsy, traumatic brain injury, stroke), \*pregnancy
- current acute or chronic medical condition requiring a medication that has psychological side-effects.
- impaired decision-making capacity in the judgment of the investigators.
Key Trial Info
Start Date :
November 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2021
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04340622
Start Date
November 12 2019
End Date
March 30 2021
Last Update
May 25 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
McLean Hospital
Belmont, Massachusetts, United States, 02478
2
MindLight, LLC
Newton Highlands, Massachusetts, United States, 02461