Transcranial Photobiomodulation for the Treatment of Opioid Cravings
Unilateral Transcranial Photobiomodulation for the Treatment of Opioid Cravings: A Blinded Placebo-Controlled Evaluation of Efficacy and Safety
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Massachusetts
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Newton Highlands, Massachusetts, United States, 02461
- MindLight, LLC
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Active
Patients will receive the active treatment.
|
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 Comparator: Sham
Patients will receive the sham treatment (the identical LED covered by aluminum foil).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opioid Craving Scale, OCS
Time Frame: immediately before and after treatments and one week later
|
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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hamilton Depression Rating Scale, HDRS
Time Frame: Before each treatment and 1 week later
|
Standard depression rating scale; 0 to 53, a low score is less depressed.
0 to 7 is no depression.
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Before each treatment and 1 week later
|
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Hamilton Anxiety Rating Scale, HARS
Time Frame: Before each treatment and 1 week later
|
A standard anxiety rating scale; 0 to 56, a lower score suggests less anxiety
|
Before each treatment and 1 week later
|
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The Positive and Negative Affect Scale, PANAS
Time Frame: Before each treatment and 1 week later
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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.
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Before each treatment and 1 week later
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fredric Schiffer, MindLight, LLC
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEIRB001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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