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| ID | Type | Description | Link |
|---|---|---|---|
| 1R43DA050358-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Mclean Hospital | OTHER |
| Harvard Medical School (HMS and HSDM) | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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Investigators will test, for safety and efficacy, a novel treatment for opiate addiction that applies a 4-minute treatment of intense near infra-red light to stimulate a side of the brain that the investigators determine to be healthier, more mature, and less traumatized. Investigators will compare an active and a sham treatment given twice weekly for 4-weeks. Investigators hope this will lead to a significant weapon in the battle against the opioid epidemic as well as lead to psychological and physiological insights into possible relations among trauma, cerebral laterality, and addiction.
This project is to demonstrate that a novel treatment for opiate addiction is safe and far superior to a sham comparison treatment. The treatment is hoped to significantly aid in the battle against the opioid epidemic that is ravaging much of the country and the world. The treatment consists of using a 4-minute application of transcranial photobiomodulation, near infra-red mode, through a supra-luminous LED, to one side of the forehead over the brain hemisphere that we determine (through a proprietary test) to have a more positive emotional valence. Based on preliminary data, we anticipate that the treatment will be very effective in reducing drug cravings, anxiety, and depression as well as in reducing relapses. Aim I will offer twice-weekly treatments to two groups, active and sham, for 4-weeks and will look specifically for differences in opioid cravings, anxiety, depression, and opioid use. The investigators will evaluate participants weekly for safety and efficacy for 3-weeks post-treatment. In Aim II a highly-regarded product engineer will work with the company to design a marketable product that may have patentable elements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduction in opioid cravings and use | Active Comparator | These participants will receive twice-weekly transcranial photobiomodulation with and 810 nm LED for 4 min for a delivery to the brain of 2.1 J/cm2. The treatment will last 4 weeks. We anticipate a 60% reduction in opioid cravings in this group. We anticipate a reduction of at least 1.6 days of use per week on average. |
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| Small reduction in opioid cravings and use | Placebo Comparator | Sham condition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| supra-luminous LED | Device | 810 nm light-emitting diode for the delivery of 2.1 J/cm2 to the brain. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Opioid Craving Scale | a published 3 question scale of opioid cravings. Each question asks the patient to rate his opioid cravings at the present time from 0 (none) to 9 (extreme). We use the average of the scores of the 3 questions. A low score is best. | One year |
| Change in Opioid drug use | TimeLine FollowBack method, measures the daily amount of opioid drug use (mg's of pills or grams used) for the period between observations. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient reports of opioid use by TimeLine FollowBack method | patient reports supported by urine drug screens and a drug hair test at the end of the study | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fredric Schiffer, MD | MindLight, LLC | Principal Investigator |
| Martin Teicher, MD, PhD | McLean Hospital and Harvard Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States | ||
| MindLight, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34447323 | Derived | Schiffer F, Khan A, Bolger E, Flynn E, Seltzer WP, Teicher MH. An Effective and Safe Novel Treatment of Opioid Use Disorder: Unilateral Transcranial Photobiomodulation. Front Psychiatry. 2021 Aug 10;12:713686. doi: 10.3389/fpsyt.2021.713686. eCollection 2021. |
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Without any identifying participant information, study data may be shared at the investigator's discretion.
upon completion of the study
Investigators will not share any individual participant identifying data. Each participant will be given a participant number and this number will be shared with the participant's data. All participant data will be shared but without any participant, personal identifying data.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 18, 2026 |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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20 participants will receive twice a week active treatment for 4-weeks of a 4-minute near-infrared light treatment through the forehead to a brain hemisphere and 20 will receive a sham treatment.
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The sham is created by putting a piece of aluminum foil over the light-emitting diode. It will be placed there or not placed there by a 3rd party so that neither the participant nor the outcomes assessor will know the condition of the study.
| Sham | Device | Light-emitting diode covered with aluminium foil |
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| Newton Highlands |
| Massachusetts |
| 02461 |
| United States |