Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders

NCT04340622 | Completed DMC FDA Device

• 2 other identifiers: R43DA0503581R43DA050358-01
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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 investigators determine to be healthier, more mature, and less traumatized. Investigators will compare an active and a sham treatment given twice weekly for 4-weeks. 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.

Conditions

Opioid-use Disorder; Opioid Dependence; Opioid Abuse

Outcome Measures

Primary Outcomes (2)

• Change in Opioid Craving Scale

  a published 3 question scale of opioid cravings. Each question asks the patient to rate his opioid cravings at the present time from 0 (none) to 9 (extreme). We use the average of the scores of the 3 questions. A low score is best.

  One year

• Change in Opioid drug use

  TimeLine FollowBack method, measures the daily amount of opioid drug use (mg's of pills or grams used) for the period between observations.

  One year

Secondary Outcomes (1)

• Change in Patient reports of opioid use by TimeLine FollowBack method

  One year

Study Arms (2)

Reduction in opioid cravings and use

ACTIVE COMPARATOR

These participants will receive twice-weekly transcranial photobiomodulation with and 810 nm LED for 4 min for a delivery to the brain of 2.1 J/cm2. The treatment will last 4 weeks. We anticipate a 60% reduction in opioid cravings in this group. We anticipate a reduction of at least 1.6 days of use per week on average.

Device: supra-luminous LED

Small reduction in opioid cravings and use

PLACEBO COMPARATOR

Sham condition.

Device: Sham

Interventions

supra-luminous LED DEVICE

810 nm light-emitting diode for the delivery of 2.1 J/cm2 to the brain.

Also known as: unilateral trancranial photobiomodulation, near-infrared mode

Reduction in opioid cravings and use

Sham DEVICE

Light-emitting diode covered with aluminium foil

Small reduction in opioid cravings and use

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• MindLight, LLC: lead
• Mclean Hospital: collaborator
• Harvard Medical School (HMS and HSDM): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MindLight, LLC

Newton Highlands, Massachusetts, 02461, United States

Location

Related Publications (1)

• Schiffer F, Khan A, Bolger E, Flynn E, Seltzer WP, Teicher MH. An Effective and Safe Novel Treatment of Opioid Use Disorder: Unilateral Transcranial Photobiomodulation. Front Psychiatry. 2021 Aug 10;12:713686. doi: 10.3389/fpsyt.2021.713686. eCollection 2021.

  PMID: 34447323 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Fredric Schiffer, MD

  MindLight, LLC

  PRINCIPAL INVESTIGATOR

• Martin Teicher, MD, PhD

  McLean Hospital and Harvard Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The sham is created by putting a piece of aluminum foil over the light-emitting diode. It will be placed there or not placed there by a 3rd party so that neither the participant nor the outcomes assessor will know the condition of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 20 participants will receive twice a week active treatment for 4-weeks of a 4-minute near-infrared light treatment through the forehead to a brain hemisphere and 20 will receive a sham treatment.

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: April 9, 2020
• Study Start: November 12, 2019
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: May 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: upon completion of the study
• Access Criteria: Investigators will not share any individual participant identifying data. Each participant will be given a participant number and this number will be shared with the participant's data. All participant data will be shared but without any participant, personal identifying data.

Locations

US (2)