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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | Patients will receive the active treatment. |
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| Sham | Sham Comparator | Patients will receive the sham treatment (the identical LED covered by aluminum foil). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Hamilton Anxiety Rating Scale, HARS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fredric Schiffer | MindLight, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MindLight, LLC | Newton Highlands | Massachusetts | 02461 | United States |
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| Label | URL |
|---|---|
| published paper describing the study | View source |
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No personal identifying information of the patients will ever be released, but data for patient numbers will be.
Data will become available publication of the study and will be available online if the study is published.
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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.
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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.
| 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. |
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A standard anxiety rating scale; 0 to 56, a lower score suggests less anxiety
| Before each treatment and 1 week later |
| 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 |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |