UnknownNot Applicable

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

United States130 participantsStarted 2024-01-22

Plain-language 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 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

percent of participants that achieve abstenense

Timeframe: up to 26 weeks

Trial details

NCT IDNCT05995873

SponsorMindLight, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-30

Contact for this trial

Fredric Schiffer, MD

781-405-8800 fred.schiffermd@gmail.com