Transcranial Photobiomodulation for the Treatment of Opioid Cravings

NCT04417738 | Completed DMC FDA Device

• 1 other identifier: NEIRB001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators wish to test the hypothesis that transcranial photobiomodulation (tPBM) (i.e., 4-minutes of 810nm near-infrared light at 250 mW/cm2 by LED to the forehead at F3 or F4 versus an indistinguishable placebo treatment) can safely reduce opioid craving in individuals with opioid dependence in a within-patient study.

Conditions

Opioid-use Disorder; Depression, Anxiety; Craving

Keywords

opioid craving; opioid use disorder; depression; anxiety; transcranial photobiomodulation; near infra-red light; dual-brain psychology; cerebral laterality

Outcome Measures

Primary Outcomes (1)

• Opioid Craving Scale, OCS

  A published scale that consists of 3 questions, each rated by the patient from 0 to 9. with 9 indicating severe cravings.

  immediately before and after treatments and one week later

Secondary Outcomes (3)

• Hamilton Depression Rating Scale, HDRS

  Before each treatment and 1 week later

• Hamilton Anxiety Rating Scale, HARS

  Before each treatment and 1 week later

• The Positive and Negative Affect Scale, PANAS

  Before each treatment and 1 week later

Study Arms (2)

Active

ACTIVE COMPARATOR

Patients will receive the active treatment.

Device: unilateral transcranial photobiomodulation, near infrared mode

Sham

SHAM COMPARATOR

Patients will receive the sham treatment (the identical LED covered by aluminum foil).

Device: Sham treatment

Interventions

unilateral transcranial photobiomodulation, near infrared mode DEVICE

The investigators are applying a supra luminous LED at 810 nm and 250 mW/cm2 to the forehead of the participant at F3 and F4.

Active

Sham treatment DEVICE

The sham treatment is identical to the active treatment except that the sham treatment has a piece of aluminum foil covering the led so that the participant will experience warmth but receive no photons.

Sham

Eligibility Criteria

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

You may qualify if:

• patients complain of opioid cravings
• between the ages of 18 and 65.
• meet criteria for a history of opioid dependence by DSM V.

You may not qualify if:

• a past history of a psychotic disorder (including schizophrenia or schizoaffective disorder)
• a history of violent behavior
• a history of a past suicide attempt
• a history of current suicidal ideation
• a history of a neurological condition (e.g. epilepsy, traumatic brain injury, stroke), pregnancy,
• any current acute or chronic medical condition that might confound the study.
• Any patient judged by an investigator to have an impaired decision-making capacity

Sponsors & Collaborators

• MindLight, LLC: lead

Study Sites (1)

MindLight, LLC

Newton Highlands, Massachusetts, 02461, United States

Location

Related Links

• published paper describing the study

MeSH Terms

Conditions

Opioid-Related Disorders; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Fredric Schiffer

  MindLight, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: One experimenter will act as the blinder and treater. Only he will know whether the patient receives the active or sham treatment and only he will prepare and provide the treatment. The patient and outcomes assessors will be blind to the treatment.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will come to the lab on 3 consecutive weekly visits. On the first, they go through the consent process and if signed, will have a clinical interview and ROS then be given baseline measures and then treated with transcranial photobiomodulation, following which they will undergo post-treatment measures. The treatment the first week will be randomized to active or sham and the second week they will receive the opposite treatment. The third week will be a follow-up of the second treatment.

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 5, 2020
• Study Start: July 1, 2019
• Primary Completion: November 15, 2019
• Study Completion: November 15, 2019
• Last Updated: May 26, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will become available publication of the study and will be available online if the study is published.

Locations

US (1)