Opioid-use DisorderNCT04340622
Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders
A study testing supra-luminous LED in people with Opioid-use Disorder and Opioid Dependence, run by MindLight, LLC at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Opioid-use Disorder, Opioid Dependence, Opioid Abuse
- What is being tested?
- supra-luminous LED
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Nov 2019to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
McLean Hospital
Belmont, Massachusetts, 02478
MindLight, LLC
Newton Highlands, Massachusetts, 02461
About this study
Official title: A Project to Test The Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders
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.
Read the detailed description
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.
- Conditions
- Opioid-use Disorder, Opioid Dependence, Opioid Abuse
- Being tested
- supra-luminous LED, Sham
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
supra-luminous LEDDevice
Also called unilateral trancranial photobiomodulation, near-infrared mode
810 nm light-emitting diode for the delivery of 2.1 J/cm2 to the brain.
ShamDevice
Light-emitting diode covered with aluminium foil
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: supra-luminous LED |
| Small reduction in opioid cravings and use | Placebo comparator | Sham condition. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: One year
Secondary outcomes (1)
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
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start12 Nov 2019
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- MindLight, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mclean Hospital, Harvard Medical School (HMS and HSDM), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Fredric Schiffer, MD, Principal investigator, MindLight, LLCMartin Teicher, MD, PhD, Principal investigator, McLean Hospital and Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340622
- Sponsor's protocol ID
- R43DA050358
- Other IDs
- 1R43DA050358-01
- Status last verified
- May 2021
- First submitted
- 25 Sep 2019
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Without any identifying participant information, study data may be shared at the investigator's discretion.
Publications
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.
PubMed 34447323
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Project to Test The Efficacy And Safety Of An Innovative Treatment Of Opiate Use Disorders
- ClinicalTrials.gov ID
- NCT04340622
- Acronym / sponsor ID
- R43DA050358
- Conditions
- Opioid-use Disorder, Opioid Dependence, Opioid Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- MindLight, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Mclean Hospital, Harvard Medical School (HMS and HSDM), National Institute on Drug Abuse (NIDA)
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 9 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Reduction in opioid cravings and use | Active comparator | Device: supra-luminous LEDThese 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. |
| Small reduction in opioid cravings and use | Placebo comparator | Device: ShamSham condition. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| supra-luminous LEDAlso: unilateral trancranial photobiomodulation, near-infrared mode810 nm light-emitting diode for the delivery of 2.1 J/cm2 to the brain. | Device | Reduction in opioid cravings and use |
| ShamLight-emitting diode covered with aluminium foil | Device | Small reduction in opioid cravings and use |
Primary outcome
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.
1 secondary outcome
Change in Patient reports of opioid use by TimeLine FollowBack method
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Derived from this study: PubMed 34447323Schiffer 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.
- Individual participant dataSharing planned: Yes. Without any identifying participant information, study data may be shared at the investigator's discretion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fredric Schiffer, MD principal investigator
MindLight, LLC
Martin Teicher, MD, PhD principal investigator
McLean Hospital and Harvard Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing supra-luminous LED in people with Opioid-use Disorder and Opioid Dependence, run by MindLight, LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Opioid Craving Scale (time frame: One year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04340622, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.