<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04417738</url>
  </required_header>
  <id_info>
    <org_study_id>NEIRB001</org_study_id>
    <nct_id>NCT04417738</nct_id>
  </id_info>
  <brief_title>Transcranial Photobiomodulation for the Treatment of Opioid Cravings</brief_title>
  <official_title>Unilateral Transcranial Photobiomodulation for the Treatment of Opioid Cravings: A Blinded Placebo-Controlled Evaluation of Efficacy and Safety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MindLight, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MindLight, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators wish to test the hypothesis that transcranial photobiomodulation (tPBM)&#xD;
      (i.e., 4-minutes of 810nm near-infrared light at 250 mW/cm2 by LED to the forehead at F3 or&#xD;
      F4 versus an indistinguishable placebo treatment) can safely reduce opioid craving in&#xD;
      individuals with opioid dependence in a within-patient study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Opioid use disorders (OUD) are an epidemic causing catastrophic consequences to individuals,&#xD;
      families, and society despite treatments including psychotherapy, substitution therapy or&#xD;
      receptor blockers, and psychoeducation. The investigators have developed a novel treatment&#xD;
      that combines transcranial photobiomodulation (t-PBM) and Schiffer's Dual Brain Psychology&#xD;
      (DBP)&#xD;
&#xD;
      The investigators will use a randomized, double-blind, placebo-controlled protocol in which&#xD;
      22 patients with significant opioid cravings and a history of recent or current OUD attended&#xD;
      three one-hour weekly sessions. After baseline measures of opioid craving, and other&#xD;
      psychometrics, subjects will receive two unilateral t-PBM applications (810 nm CW LED, 250&#xD;
      mW/cm2, 60 J/cm2, 4 min) or a sham (foil-covered LED) at F3 or F4. Prior to any treatment,&#xD;
      the investigators will use 2 tests to determine which hemisphere is more associated with a&#xD;
      negative outlook and cravings and will treat that side before the more positive hemisphere.&#xD;
      The primary outcome measure will be an opioid craving scale (OCS). plus weekly Hamilton&#xD;
      Depression (HDRS) and Anxiety (HARS) Rating Scales prior to treatments. Patients will be&#xD;
      closely monitored for any possible adverse side-effects from the treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Actual">November 15, 2019</completion_date>
  <primary_completion_date type="Actual">November 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Opioid Craving Scale, OCS</measure>
    <time_frame>immediately before and after treatments and one week later</time_frame>
    <description>A published scale that consists of 3 questions, each rated by the patient from 0 to 9. with 9 indicating severe cravings.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hamilton Depression Rating Scale, HDRS</measure>
    <time_frame>Before each treatment and 1 week later</time_frame>
    <description>Standard depression rating scale; 0 to 53, a low score is less depressed. 0 to 7 is no depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hamilton Anxiety Rating Scale, HARS</measure>
    <time_frame>Before each treatment and 1 week later</time_frame>
    <description>A standard anxiety rating scale; 0 to 56, a lower score suggests less anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Positive and Negative Affect Scale, PANAS</measure>
    <time_frame>Before each treatment and 1 week later</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Opioid-use Disorder</condition>
  <condition>Depression, Anxiety</condition>
  <condition>Craving</condition>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive the active treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients will receive the sham treatment (the identical LED covered by aluminum foil).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>unilateral transcranial photobiomodulation, near infrared mode</intervention_name>
    <description>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.</description>
    <arm_group_label>Active</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham treatment</intervention_name>
    <description>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.</description>
    <arm_group_label>Sham</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients complain of opioid cravings&#xD;
&#xD;
          -  between the ages of 18 and 65.&#xD;
&#xD;
          -  meet criteria for a history of opioid dependence by DSM V.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a past history of a psychotic disorder (including schizophrenia or schizoaffective&#xD;
             disorder)&#xD;
&#xD;
          -  a history of violent behavior&#xD;
&#xD;
          -  a history of a past suicide attempt&#xD;
&#xD;
          -  a history of current suicidal ideation&#xD;
&#xD;
          -  a history of a neurological condition (e.g. epilepsy, traumatic brain injury, stroke),&#xD;
             pregnancy,&#xD;
&#xD;
          -  any current acute or chronic medical condition that might confound the study.&#xD;
&#xD;
          -  Any patient judged by an investigator to have an impaired decision-making capacity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fredric Schiffer</last_name>
    <role>Principal Investigator</role>
    <affiliation>MindLight, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MindLight, LLC</name>
      <address>
        <city>Newton Highlands</city>
        <state>Massachusetts</state>
        <zip>02461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.frontiersin.org/articles/10.3389/fpsyt.2020.00827/full</url>
    <description>published paper describing the study</description>
  </link>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>May 22, 2021</last_update_submitted>
  <last_update_submitted_qc>May 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>opioid craving</keyword>
  <keyword>opioid use disorder</keyword>
  <keyword>depression</keyword>
  <keyword>anxiety</keyword>
  <keyword>transcranial photobiomodulation</keyword>
  <keyword>near infra-red light</keyword>
  <keyword>dual-brain psychology</keyword>
  <keyword>cerebral laterality</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>No personal identifying information of the patients will ever be released, but data for patient numbers will be.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data will become available publication of the study and will be available online if the study is published.</ipd_time_frame>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04417738
org study id: NEIRB001
nct id: NCT04417738
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
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.
allocation: Randomized
intervention model: Sequential Assignment
intervention 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.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: 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.
measure: Opioid Craving Scale, OCS
time frame: immediately before and after treatments and one week later
description: A published scale that consists of 3 questions, each rated by the patient from 0 to 9. with 9 indicating severe cravings.
measure: Hamilton Depression Rating Scale, HDRS
time frame: Before each treatment and 1 week later
description: Standard depression rating scale; 0 to 53, a low score is less depressed. 0 to 7 is no depression.
measure: Hamilton Anxiety Rating Scale, HARS
time frame: Before each treatment and 1 week later
description: A standard anxiety rating scale; 0 to 56, a lower score suggests less anxiety
measure: The Positive and Negative Affect Scale, PANAS
time frame: Before each treatment and 1 week later
description: 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.
arm group label: Active
arm group type: Active Comparator
description: Patients will receive the active treatment.
arm group label: Sham
arm group type: Sham Comparator
description: Patients will receive the sham treatment (the identical LED covered by aluminum foil).
intervention type: Device
intervention name: unilateral transcranial photobiomodulation, near infrared mode
description: 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.
arm group label: Active
intervention type: Device
intervention name: Sham treatment
description: 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.
arm group label: Sham
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Fredric Schiffer
role: Principal Investigator
affiliation: MindLight, LLC
facility: 
country: United States
url: https://www.frontiersin.org/articles/10.3389/fpsyt.2020.00827/full
description: published paper describing the study
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
mesh term: Depression
sharing ipd: Yes
ipd description: No personal identifying information of the patients will ever be released, but data for patient numbers will be.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data will become available publication of the study and will be available online if the study is published.