Opioid-use DisorderNCT04417738
Transcranial Photobiomodulation for the Treatment of Opioid Cravings
A study testing unilateral transcranial photobiomodulation, near infrared mode in people with Opioid-use Disorder and Depression, Anxiety, run by MindLight, LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid-use Disorder, Depression, Anxiety, Craving
- What is being tested?
- unilateral transcranial photobiomodulation, near infrared mode
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 15 Nov 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients complain of opioid cravings
- between the ages of 18 and 65.
- meet criteria for a history of opioid dependence by DSM V.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
MindLight, LLC
Newton Highlands, Massachusetts, 02461
About this study
Official title: Unilateral Transcranial Photobiomodulation for the Treatment of Opioid Cravings: A Blinded Placebo-Controlled Evaluation of Efficacy and Safety
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.
Read the 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.
- Conditions
- Opioid-use Disorder, Depression, Anxiety, Craving
- Being tested
- unilateral transcranial photobiomodulation, near infrared mode, Sham treatment
- Keywords
- opioid craving, opioid use disorder, depression, anxiety, transcranial photobiomodulation, near infra-red light, dual-brain psychology, cerebral laterality
- Medical subject headings
- Opioid-Related Disorders, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unilateral transcranial photobiomodulation, near infrared modeDevice
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.
Sham treatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Patients will receive the active treatment. Receives: Device: unilateral transcranial photobiomodulation, near infrared mode |
| Sham | Sham comparator | Patients will receive the sham treatment (the identical LED covered by aluminum foil). Receives: Device: Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately before and after treatments and one week later
Secondary outcomes (3)
Hamilton Depression Rating Scale, HDRS
Standard depression rating scale; 0 to 53, a low score is less depressed. 0 to 7 is no depression.
Measured: Before each treatment and 1 week later
Hamilton Anxiety Rating Scale, HARS
A standard anxiety rating scale; 0 to 56, a lower score suggests less anxiety
Measured: 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.
Measured: Before each treatment and 1 week later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start1 Jul 2019
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Sequential
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- MindLight, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fredric Schiffer, Principal investigator, MindLight, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417738
- Sponsor's protocol ID
- NEIRB001
- Status last verified
- Jun 2020
- First submitted
- 2 Jun 2020
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: No personal identifying information of the patients will ever be released, but data for patient numbers will be.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral Transcranial Photobiomodulation for the Treatment of Opioid Cravings: A Blinded Placebo-Controlled Evaluation of Efficacy and Safety
- ClinicalTrials.gov ID
- NCT04417738
- Acronym / sponsor ID
- NEIRB001
- Conditions
- Opioid-use Disorder, Depression, Anxiety, Craving
- Keywords
- opioid craving, opioid use disorder, depression, anxiety, transcranial photobiomodulation, near infra-red light, dual-brain psychology, cerebral laterality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- MindLight, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 5 Jun 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: unilateral transcranial photobiomodulation, near infrared modePatients will receive the active treatment. |
| Sham | Sham comparator | Device: Sham treatmentPatients will receive the sham treatment (the identical LED covered by aluminum foil). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients complain of opioid cravings
- between the ages of 18 and 65.
- meet criteria for a history of opioid dependence by DSM V.
Key exclusion criteria (7 listed)
- 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,
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 |
|---|---|---|
| unilateral transcranial photobiomodulation, near infrared modeThe investigators are applying a supra luminous LED at 810 nm and 250 mW/cm2 to the forehead of the participant at F3 and F4. | Device | Active |
| Sham treatmentThe 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. | Device | Sham |
Primary outcome
Opioid Craving Scale, OCS
Time frame: 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.
3 secondary outcomes
Hamilton Depression Rating Scale, HDRS
Time frame: Before each treatment and 1 week later
Hamilton Anxiety Rating Scale, HARS
Time frame: Before each treatment and 1 week later
The Positive and Negative Affect Scale, PANAS
Time frame: Before each treatment and 1 week later
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 26 May 2021.
- published paper describing the studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. No personal identifying information of the patients will ever be released, but data for patient numbers will be.
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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 principal investigator
MindLight, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing unilateral transcranial photobiomodulation, near infrared mode in people with Opioid-use Disorder and Depression, Anxiety, run by MindLight, LLC at 1 site 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 3 inclusion and 7 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 26 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 1 site 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?
Opioid Craving Scale, OCS (time frame: immediately before and after treatments and one week later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2021.