Transcranial Photobiomodulation for the Treatment of Opioid Cravings

Opioid-use Disorder Clinical Trial

Official title:

Unilateral Transcranial Photobiomodulation for the Treatment of Opioid Cravings: A Blinded Placebo-Controlled Evaluation of Efficacy and Safety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04417738
• Other study ID #: NEIRB001
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: November 15, 2019

Study information

• Verified date: June 2020
• Source: MindLight, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Opioid use disorders (OUD) are an epidemic causing catastrophic consequences to individuals, families, and society despite treatments including psychotherapy, substitution therapy or receptor blockers, and psychoeducation. The investigators have developed a novel treatment that combines transcranial photobiomodulation (t-PBM) and Schiffer's Dual Brain Psychology (DBP) The investigators will use a randomized, double-blind, placebo-controlled protocol in which 22 patients with significant opioid cravings and a history of recent or current OUD attended three one-hour weekly sessions. After baseline measures of opioid craving, and other psychometrics, subjects will receive two unilateral t-PBM applications (810 nm CW LED, 250 mW/cm2, 60 J/cm2, 4 min) or a sham (foil-covered LED) at F3 or F4. Prior to any treatment, the investigators will use 2 tests to determine which hemisphere is more associated with a negative outlook and cravings and will treat that side before the more positive hemisphere. The primary outcome measure will be an opioid craving scale (OCS). plus weekly Hamilton Depression (HDRS) and Anxiety (HARS) Rating Scales prior to treatments. Patients will be closely monitored for any possible adverse side-effects from the treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: November 15, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Craving
• Depression
• Depression, Anxiety
• Opioid-use Disorder

Intervention

Device:
• unilateral transcranial photobiomodulation, near infrared mode
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.
• Sham treatment
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.

Locations

Country	Name	City	State
United States	MindLight, LLC	Newton Highlands	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
MindLight, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hamilton Depression Rating Scale, HDRS	Standard depression rating scale; 0 to 53, a low score is less depressed. 0 to 7 is no depression.	Before each treatment and 1 week later
Secondary	Hamilton Anxiety Rating Scale, HARS	A standard anxiety rating scale; 0 to 56, a lower score suggests less anxiety	Before each treatment and 1 week later
Secondary	The Positive and Negative Affect Scale, PANAS	Patient rated positive and negative affects from 1 to 5. Five indicates extreme positive or negative affect. Scores for Positive and Negative Affects range from 0 to 25. A higher positive affect score and a lower negative affect score are better.	Before each treatment and 1 week later

External Links

•   published paper describing the study