Transcranial Photobiomodulation for the Treatment of Opioid Cravings
- Conditions
- Depression, AnxietyCravingOpioid-use Disorder
- Interventions
- Device: unilateral transcranial photobiomodulation, near infrared modeDevice: Sham treatment
- Registration Number
- NCT04417738
- Lead Sponsor
- MindLight, LLC
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- patients complain of opioid cravings
- between the ages of 18 and 65.
- meet criteria for a history of opioid dependence by DSM V.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Active unilateral transcranial photobiomodulation, near infrared mode Patients will receive the active treatment. Sham Sham treatment Patients will receive the sham treatment (the identical LED covered by aluminum foil).
- Primary Outcome Measures
Name Time Method Opioid Craving Scale, OCS 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.
- Secondary Outcome Measures
Name Time Method Hamilton Depression Rating Scale, HDRS 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.
Hamilton Anxiety Rating Scale, HARS Before each treatment and 1 week later A standard anxiety rating scale; 0 to 56, a lower score suggests less anxiety
The Positive and Negative Affect Scale, PANAS Before each treatment and 1 week later 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.
Trial Locations
- Locations (1)
MindLight, LLC
🇺🇸Newton Highlands, Massachusetts, United States