RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 investigators determine to be healthier, more mature, and less traumatized. Investigators will compare among actively using participants an active and a sham treatment given either once or twice weekly for 25-weeks at 2 sites. Investigators hope this will lead to a significant weapon in the battle against the opioid epidemic as well as lead to psychological and physiological insights into possible relations among trauma, cerebral laterality, and addiction.

Official Title

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

Quick Facts

Study Start:2024-01-22
Study Completion:2024-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05995873

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or non-pregnant females between 18-65 years of age
  2. * Individuals having an opioid use disorder with mild-to-moderately severe symptoms
  1. * Individuals who are pregnant,
  2. * Individuals who are psychotic,
  3. * Individuals who are actively suicidal,
  4. * Individuals who are a danger to self or others,
  5. * Individuals who are who have a history of severe psychiatric or neurological disorders or life-threatening medical illness.
  6. * Individuals will be excluded with chronic pain requiring opioid treatment.
  7. * Individuals who are who are breastfeeding,
  8. * Individuals who are adults requiring a legally authorized representative.

Contacts and Locations

Study Contact

Fredric Schiffer, MD
CONTACT
781-405-8800
fred.schiffermd@gmail.com
Nawar Wood, BA
CONTACT
617-860-9002
nawar.wood@gmail.com

Study Locations (Sites)

MindLight, LLC
Newton Highlands, Massachusetts, 02461
United States

Collaborators and Investigators

Sponsor: MindLight, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-22
Study Completion Date2024-08-30

Study Record Updates

Study Start Date2024-01-22
Study Completion Date2024-08-30

Terms related to this study

Additional Relevant MeSH Terms

  • Opioid Use Disorder, Moderate
  • Opioid Use
  • Opioid Dependence
  • Opioid Abuse
  • Opiate Dependence
  • Opioid Use, Unspecified