Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders
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|ClinicalTrials.gov Identifier: NCT04340622|
Recruitment Status : Completed
First Posted : April 9, 2020
Last Update Posted : May 25, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Opioid-use Disorder Opioid Dependence Opioid Abuse||Device: supra-luminous LED Device: Sham||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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.|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||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.|
|Official Title:||A Project to Test The Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders|
|Actual Study Start Date :||November 12, 2019|
|Actual Primary Completion Date :||March 30, 2021|
|Actual Study Completion Date :||March 30, 2021|
Active Comparator: Reduction in opioid cravings and use
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.
Device: supra-luminous LED
810 nm light-emitting diode for the delivery of 2.1 J/cm2 to the brain.
Other Name: unilateral trancranial photobiomodulation, near-infrared mode
Placebo Comparator: Small reduction in opioid cravings and use
Light-emitting diode covered with aluminium foil
- Change in Opioid Craving Scale [ Time Frame: One year ]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.
- Change in Opioid drug use [ Time Frame: One year ]TimeLine FollowBack method, measures the daily amount of opioid drug use (mg's of pills or grams used) for the period between observations.
- Change in Patient reports of opioid use by TimeLine FollowBack method [ Time Frame: One year ]patient reports supported by urine drug screens and a drug hair test at the end of the study
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|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- all patients must between the ages of 18 and 70
- meet criterion for a history of Opioid Use Disorder (OUD) on a Diagnostic Interview.
- have opioid cravings
- Enrollment will be made without regard to gender or ethnicity.
- Patients who are receiving treatment for OUD or other psychiatric disorders, either psychological or pharmacological treatments, may continue their treatment during the time of the study but will be asked to try not to alter their treatment from the onset of the experiment until its conclusion. The statistical analysis will include covariates for doses of buprenorphine and methadone and use of non-prescribed opioids
- past history of a psychotic disorder (including schizophrenia or schizoaffective disorder)
- history of violent behavior
- history of a past suicide gesture or attempt, a history of current suicidal ideation, *history of a neurological condition (e.g. epilepsy, traumatic brain injury, stroke), *pregnancy
- current acute or chronic medical condition requiring a medication that has psychological side-effects.
- impaired decision-making capacity in the judgment of the investigators.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04340622
|United States, Massachusetts|
|Belmont, Massachusetts, United States, 02478|
|Newton Highlands, Massachusetts, United States, 02461|
|Principal Investigator:||Fredric Schiffer, MD||MindLight, LLC|
|Principal Investigator:||Martin Teicher, MD, PhD||McLean Hospital and Harvard Medical School|
|Responsible Party:||MindLight, LLC|
|Other Study ID Numbers:||
R43DA050358 ( U.S. NIH Grant/Contract )
1R43DA050358-01 ( U.S. NIH Grant/Contract )
|First Posted:||April 9, 2020 Key Record Dates|
|Last Update Posted:||May 25, 2021|
|Last Verified:||May 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||Without any identifying participant information, study data may be shared at the investigator's discretion.|
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
|Time Frame:||upon completion of the study|
|Access Criteria:||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.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Product Manufactured in and Exported from the U.S.:||No|