xml: <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/NCT06021431</url>
    </required_header>
    <id_info>
      <org_study_id>00157860</org_study_id>
      <secondary_id>5R44DA053848</secondary_id>
      <nct_id>NCT06021431</nct_id>
    </id_info>
    <brief_title>Virtual Reality Cognitive-Affective Training for Opioid Use Disorder- A Phase 2 RCT</brief_title>
    <official_title>Digital Therapeutic Development of Virtual Cognitive-Affective Training for Opioid Use Disorder: A Phase 2 Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>BehaVR LLC</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Utah</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Institute on Drug Abuse (NIDA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>BehaVR 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 goal of this clinical trial is to examine the usefulness of a virtual reality-delivered&#xD;
        intervention for individuals with opioid use disorder who are taking medication. The main&#xD;
        question it aims to answer is will people with opioid use disorder who receive the study&#xD;
        intervention, Mindfulness-Oriented Recovery Enhancement in Virtual Reality (MORE-VR), have&#xD;
        fewer days in which they use opioids than will people who just receive their usual treatment.&#xD;
        Participants will be randomly assigned to either receive 8 weekly sessions of MORE-VR in&#xD;
        addition to their usual treatment, or treatment as usual only. Researchers will compare these&#xD;
        groups at the end of treatment and three months after treatment is over on number of days of&#xD;
        opioid use and time until first opioid use lapse, as well as drug craving and mood.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This project is a Phase II, two-arm, parallel randomized controlled trial (RCT) of a virtual&#xD;
        reality form of Mindfulness-Oriented Recovery Enhancement (MORE-VR) versus treatment as usual&#xD;
        (TAU) for patients receiving medications for opioid use disorder (MOUD) to assess the&#xD;
        efficacy of the MORE-VR system. Participants will be randomized (1:1) to either 8 weekly&#xD;
        sessions of MORE-VR or TAU. Participants will be assessed at intake, post-treatment, and a 3&#xD;
        month post-treatment follow-up. The primary outcome assessed will be days of opioid use.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">May 2026</completion_date>
    <primary_completion_date type="Anticipated">March 2026</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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Days of opioid use</measure>
      <time_frame>Baseline to post-treatment assessment (8 weeks)</time_frame>
      <description>Days of opioid use assessed with the Timeline Followback method, ecological momentary assessments, and/or drug toxicology screen</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Days of opioid use at follow-up</measure>
      <time_frame>Baseline to 3 months post treatment (20 weeks from baseline)</time_frame>
      <description>Days of opioid use assessed with the Timeline Followback method, ecological momentary assessments, and/or drug toxicology screen</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time until opioid lapse</measure>
      <time_frame>Baseline through 3 month post-treatment follow-up</time_frame>
      <description>Number of days until opioid lapse assessed with the Timeline Followback method, ecological momentary assessments, and/or drug toxicology screen</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time until dropout from opioid use disorder treatment</measure>
      <time_frame>Baseline through 3 month post-treatment follow-up</time_frame>
      <description>Number of days unti dropout from treatment, assessed by Timeline Followback and chart review</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Desire for drugs</measure>
      <time_frame>Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period</time_frame>
      <description>Desires for Drug Questionnaire, range from 14 to 98, higher scores indicating more intense desires for drugs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Opioid craving</measure>
      <time_frame>Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period</time_frame>
      <description>0-10 numeric rating scale via ecological momentary assessment (0=no craving, 10=extreme craving).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Positive Affect</measure>
      <time_frame>Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period</time_frame>
      <description>0-10 numeric rating scale via ecological momentary assessment (0=no positive affect, 10=extremely strong positive affect).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Negative Affect</measure>
      <time_frame>Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period</time_frame>
      <description>0-10 numeric rating scale via ecological momentary assessment (0=no negative affect, 10=extremely strong negative affect).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Positive and Negative Affect Schedule</measure>
      <time_frame>Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period</time_frame>
      <description>A 20-item scale measuring both positive and negative affect, where each affective term is rated on a scale of 1 (not at all) to 5 (very much)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Distress</measure>
      <time_frame>Baseline through 3 month post-treatment follow-up</time_frame>
      <description>Emotional distress measured by the Depression Anxiety Stress Scale, range from 0 to 63, higher scores indicating worse distress.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related Quality of Life</measure>
      <time_frame>Baseline through 3 month post-treatment follow-up</time_frame>
      <description>World Health Organization Quality of Life Scale Quality of life measured by the World Health Organization Quality of Life Scale (WHO-5), scores ranging from 0 to 25, with higher scores indicating better quality of life.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Drug cue reactivity</measure>
      <time_frame>Baseline to immediately after the intervention</time_frame>
      <description>For a subset of participants, we will asses change from baseline in neurophysiological response during lab-based task involving presentation of drug cues designed to measure cue-reactivity.</description>
    </other_outcome>
    <other_outcome>
      <measure>Emotion regulation</measure>
      <time_frame>Baseline to immediately after the intervention</time_frame>
      <description>For a subset of participants, we will assess change from baseline in neurophysiological response during lab-based task involving presentation of emotional stimuli.</description>
    </other_outcome>
    <other_outcome>
      <measure>Theta oscillations</measure>
      <time_frame>Baseline to immediately after the intervention</time_frame>
      <description>For a subset of participants, we will assess theta oscillations as measured by EEG during meditation</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">128</enrollment>
    <condition>Opioid Use Disorder</condition>
    <arm_group>
      <arm_group_label>MORE-VR</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>An 8-session version of Mindfulness-Oriented Recovery Enhancement (MORE) delivered by virtual reality. The treatment involves training in mindfulness, reappraisal, and savoring techniques to address OUD.&#xD;
  Participants in this arm will also receive Treatment as usual (TAU) with medications for opioid use disorder (MOUD) such as buprenorphine or methadone plus any psychological counseling they are already receiving in their standard care.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment as Usual (TAU)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Treatment as usual (TAU) with medications for opioid use disorder (MOUD) such as buprenorphine or methadone plus any psychological counseling they are already receiving in their standard care.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>MORE-VR</intervention_name>
      <description>An 8-session version of Mindfulness-Oriented Recovery Enhancement (MORE) delivered by virtual reality. The treatment involves training in mindfulness,reappraisal, and savoring techniques to address OUD.&#xD;
  Combination Product: Participants in this arm will also receive Treatment as usual (TAU) with medications for opioid use disorder (MOUD). Usual addictions treatment with medications such as buprenorphine or methadone plus psychological counseling.</description>
      <arm_group_label>MORE-VR</arm_group_label>
      <other_name>Mindfulness-Oriented Recovery Enhancement in Virtual Reality</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Treatment as Usual</intervention_name>
      <description>Participants will receive their usual treatment for OUD, including medications such as buprenorphine or methadone and any counseling they might already be receiving</description>
      <arm_group_label>MORE-VR</arm_group_label>
      <arm_group_label>Treatment as Usual (TAU)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years of age or older&#xD;
  &#xD;
            -  current DSM-5 OUD diagnosis&#xD;
  &#xD;
            -  prescribed medications for opioid use disorder (e.g., buprenorphine, methadone)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  completion of a standardized mindfulness intervention (e.g., MORE, MBRP, MBSR)&#xD;
  &#xD;
            -  active psychosis or suicidality&#xD;
  &#xD;
            -  reports, or is noted by clinical or study staff as showing cognitive impairment&#xD;
  &#xD;
            -  condition which might be contraindicated for VR use including seizure disorder,&#xD;
               vertigo, severe motion sickness, recent concussion&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Risa Weisberg, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>BehaVR LLC</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Risa Weisberg, PhD</last_name>
      <phone>502-777-1593</phone>
      <email>risaweisberg@behavr.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Eric Garland, PhD</last_name>
      <phone>801-581-3826</phone>
      <email>eric.garland@socwk.utah.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Utah</name>
        <address>
          <city>Salt Lake City</city>
          <state>Utah</state>
          <zip>84112</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Eric Garland, PhD</last_name>
        <phone>801-581-3826</phone>
        <email>eric.garland@socwk.utah.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Mindfulness</keyword>
    <keyword>Virtual Reality</keyword>
    <keyword>Opioid Use Disorder</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Opioid-Related Disorders</mesh_term>
      <mesh_term>Substance-Related Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Data will be available after publication of the primary, secondary, and mechanistic outcomes of the trial.</ipd_time_frame>
      <ipd_access_criteria>Data will be available with a signed data access agreement</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06021431
  org study id: 00157860
  secondary id: 5R44DA053848
  nct id: NCT06021431
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  The goal of this clinical trial is to examine the usefulness of a virtual reality-delivered
        intervention for individuals with opioid use disorder who are taking medication. The main
        question it aims to answer is will people with opioid use disorder who receive the study
        intervention, Mindfulness-Oriented Recovery Enhancement in Virtual Reality (MORE-VR), have
        fewer days in which they use opioids than will people who just receive their usual treatment.
        Participants will be randomly assigned to either receive 8 weekly sessions of MORE-VR in
        addition to their usual treatment, or treatment as usual only. Researchers will compare these
        groups at the end of treatment and three months after treatment is over on number of days of
        opioid use and time until first opioid use lapse, as well as drug craving and mood.
  This project is a Phase II, two-arm, parallel randomized controlled trial (RCT) of a virtual
        reality form of Mindfulness-Oriented Recovery Enhancement (MORE-VR) versus treatment as usual
        (TAU) for patients receiving medications for opioid use disorder (MOUD) to assess the
        efficacy of the MORE-VR system. Participants will be randomized (1:1) to either 8 weekly
        sessions of MORE-VR or TAU. Participants will be assessed at intake, post-treatment, and a 3
        month post-treatment follow-up. The primary outcome assessed will be days of opioid use.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Days of opioid use
  time frame: Baseline to post-treatment assessment (8 weeks)
  description: Days of opioid use assessed with the Timeline Followback method, ecological momentary assessments, and/or drug toxicology screen
  measure: Days of opioid use at follow-up
  time frame: Baseline to 3 months post treatment (20 weeks from baseline)
  description: Days of opioid use assessed with the Timeline Followback method, ecological momentary assessments, and/or drug toxicology screen
  measure: Time until opioid lapse
  time frame: Baseline through 3 month post-treatment follow-up
  description: Number of days until opioid lapse assessed with the Timeline Followback method, ecological momentary assessments, and/or drug toxicology screen
  measure: Time until dropout from opioid use disorder treatment
  time frame: Baseline through 3 month post-treatment follow-up
  description: Number of days unti dropout from treatment, assessed by Timeline Followback and chart review
  measure: Desire for drugs
  time frame: Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period
  description: Desires for Drug Questionnaire, range from 14 to 98, higher scores indicating more intense desires for drugs
  measure: Opioid craving
  time frame: Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period
  description: 0-10 numeric rating scale via ecological momentary assessment (0=no craving, 10=extreme craving).
  measure: Positive Affect
  time frame: Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period
  description: 0-10 numeric rating scale via ecological momentary assessment (0=no positive affect, 10=extremely strong positive affect).
  measure: Negative Affect
  time frame: Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period
  description: 0-10 numeric rating scale via ecological momentary assessment (0=no negative affect, 10=extremely strong negative affect).
  measure: Positive and Negative Affect Schedule
  time frame: Baseline, post-treatment, 3 month post-treatment follow-up, and weekly during intervention period
  description: A 20-item scale measuring both positive and negative affect, where each affective term is rated on a scale of 1 (not at all) to 5 (very much)
  measure: Distress
  time frame: Baseline through 3 month post-treatment follow-up
  description: Emotional distress measured by the Depression Anxiety Stress Scale, range from 0 to 63, higher scores indicating worse distress.
  measure: Health-related Quality of Life
  time frame: Baseline through 3 month post-treatment follow-up
  description: World Health Organization Quality of Life Scale Quality of life measured by the World Health Organization Quality of Life Scale (WHO-5), scores ranging from 0 to 25, with higher scores indicating better quality of life.
  measure: Drug cue reactivity
  time frame: Baseline to immediately after the intervention
  description: For a subset of participants, we will asses change from baseline in neurophysiological response during lab-based task involving presentation of drug cues designed to measure cue-reactivity.
  measure: Emotion regulation
  time frame: Baseline to immediately after the intervention
  description: For a subset of participants, we will assess change from baseline in neurophysiological response during lab-based task involving presentation of emotional stimuli.
  measure: Theta oscillations
  time frame: Baseline to immediately after the intervention
  description: For a subset of participants, we will assess theta oscillations as measured by EEG during meditation
  arm group label: MORE-VR
  arm group type: Experimental
  description: An 8-session version of Mindfulness-Oriented Recovery Enhancement (MORE) delivered by virtual reality. The treatment involves training in mindfulness, reappraisal, and savoring techniques to address OUD.
  Participants in this arm will also receive Treatment as usual (TAU) with medications for opioid use disorder (MOUD) such as buprenorphine or methadone plus any psychological counseling they are already receiving in their standard care.
  arm group label: Treatment as Usual (TAU)
  arm group type: Active Comparator
  description: Treatment as usual (TAU) with medications for opioid use disorder (MOUD) such as buprenorphine or methadone plus any psychological counseling they are already receiving in their standard care.
  intervention type: Device
  intervention name: MORE-VR
  description: An 8-session version of Mindfulness-Oriented Recovery Enhancement (MORE) delivered by virtual reality. The treatment involves training in mindfulness,reappraisal, and savoring techniques to address OUD.
  Combination Product: Participants in this arm will also receive Treatment as usual (TAU) with medications for opioid use disorder (MOUD). Usual addictions treatment with medications such as buprenorphine or methadone plus psychological counseling.
  arm group label: MORE-VR
  other name: Mindfulness-Oriented Recovery Enhancement in Virtual Reality
  intervention type: Other
  intervention name: Treatment as Usual
  description: Participants will receive their usual treatment for OUD, including medications such as buprenorphine or methadone and any counseling they might already be receiving
  arm group label: MORE-VR
  arm group label: Treatment as Usual (TAU)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Risa Weisberg, PhD
  role: Principal Investigator
  affiliation: BehaVR LLC
  last name: Risa Weisberg, PhD
  phone: 502-777-1593
  email: risaweisberg@behavr.com
  last name: Eric Garland, PhD
  phone: 801-581-3826
  email: eric.garland@socwk.utah.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Opioid-Related Disorders
  mesh term: Substance-Related Disorders
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Data will be available after publication of the primary, secondary, and mechanistic outcomes of the trial.
  ipd access criteria: Data will be available with a signed data access agreement