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/NCT06038409</url>
    </required_header>
    <id_info>
      <org_study_id>RIVERFoundation 001</org_study_id>
      <nct_id>NCT06038409</nct_id>
    </id_info>
    <brief_title>Ketamine Treatment Plans for Chronic Conditions</brief_title>
    <official_title>Understanding the Safety of Home Ketamine Treatment Plans for Chronic Conditions</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>RIVER Foundation</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>RIVER Foundation</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        A study aimed to assess the efficacy of the various approaches to prescribing Ketamine&#xD;
        currently in use off-label. The focus will be to include ketamine within the study plan of&#xD;
        those with chronic conditions who are receiving ketamine.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Ketamine can be administered in multiple ways (IV, IM, SubQ, and Sublingual, among others),&#xD;
        and there have been few if any, studies that have compared the impact of Ketamine at home&#xD;
        without any thearpy.&#xD;
  &#xD;
        The study will identify other treatment modalities used in concurrence with Ketamine.&#xD;
        Psychotherapy, music therapy, and acutherapy are some of the most popular. How do these&#xD;
        adjunct therapies affect the outcomes of Ketamine treatments?&#xD;
  &#xD;
        Secondarily, the study will focus on these significant issues to observe the impact of&#xD;
        Ketamine treatments and suicidal ideation. Suicidal ideation is multifaceted and is one&#xD;
        reason for prescribing off-label Ketamine. Chronic issues such as depression, pain, and&#xD;
        anxiety have been identified as underlying causes and may be improvable with Ketamine.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Ketamine route of use acceptability.</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Compare and Contrast the different methods and uses of ketamine for acceptability for the route of use. (ie oral sublingual or nasal spray)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mental Health PHQ9</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>The use of psychological scales to measure participants' mental health with the use of ketamine. Three scales will be charted to examine the mental health of the participant.&#xD;
  The Patient Health Questionnaire-9 (PHQ9), Patient Health Questionnaire 9 has a possible range of 0-27. Zero being no depression and 27 being severe depression.&#xD;
  Participants will be given a baseline survey and will be given a survey to complete every time they request a ketamine renewal while participating in the study. A multiline graph will show the results of the amount of ketamine and the PHQ9 will be produced.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mental Health GAD7</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Participants will be screened using the Generalized Anxiety Disorder-7 (GAD7) with a total score for the seven items ranging from 0 to 21. Scores 5, 10, and 15 represent cut points for mild, moderate, and severe anxiety, respectively.&#xD;
  Participants will be given a baseline survey and will be given a survey to complete every time they request a ketamine renewal while participating in the study. A multiline graph will show the results of the amount of ketamine and the GAD7 will be produced.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Mental Health PCL5</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Participants will be screened using the Posttraumatic Stress Disorder Checklist (PCL-5) PCL-5. On a 4-point scale, scores can be tabulated for individual items to give information about the severity of the four DSM-5 symptom clusters. If a score of 2 (moderate) is considered to be a positive endorsement of a given criterion, the PCL-5 can be used in combination with a clinical interview to make a provisional DSM-5 diagnosis. Testing the PCL-5 with veterans has determined a score of 31 to 33 to be a valid cutoff for a positive screen. The scores range from 0-80, 0 being no symptoms to extreme issues with post-traumatic stress disorder.&#xD;
  Participants will be given a baseline survey and will be given a survey to complete every time they request a ketamine renewal while participating in the study. A multiline graph will show the results of the amount of ketamine and the PCL5 will be produced.</description>
    </primary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Chronic Pain</condition>
    <condition>Depressive Disorder</condition>
    <condition>Anxiety Disorders</condition>
    <condition>Chronic Disease</condition>
    <arm_group>
      <arm_group_label>Chronic Pain</arm_group_label>
      <description>The use of ketamine in chronic pain</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Depressive Disorders</arm_group_label>
      <description>The use of ketamine in depressive disorders</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Anxiety Disorders</arm_group_label>
      <description>The use of ketamine in anxiety disorders</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Chronic Condtions</arm_group_label>
      <description>The use of ketamine in chronic conditions</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ketamine</intervention_name>
      <description>The efficacy of the various approaches to prescribing Ketamine currently in use off-label. The focus will be to include ketamine within the treatment plan of those with chronic conditions</description>
      <arm_group_label>Anxiety Disorders</arm_group_label>
      <arm_group_label>Chronic Condtions</arm_group_label>
      <arm_group_label>Chronic Pain</arm_group_label>
      <arm_group_label>Depressive Disorders</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          People with chronic conditions that need either their mental health or pain controlled.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Must have an identifiable chronic condition.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Healthy population&#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>Edward Lesofski, MS</last_name>
      <role>Study Director</role>
      <affiliation>RIVER Foundation</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ed Lesofski</last_name>
      <phone>406-465-9504</phone>
      <email>ed@riverofchange.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>James Taggart, MD</last_name>
      <phone>415-713-6654</phone>
      <email>jrtaggartmd@aol.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>RIVER Telehealth</name>
        <address>
          <city>Helena</city>
          <state>Montana</state>
          <zip>59601</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ed Lesofski, MS</last_name>
        <phone>406-465-9504</phone>
        <email>ed@riverofchange.org</email>
      </contact>
      <investigator>
        <last_name>James Taggart, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Frank Yurasek, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Edward Lesofski, MS</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jeffery Newton</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://research.riverofchange.org</url>
      <description>RIVER's research web site</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>January 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Chronic Pain</mesh_term>
      <mesh_term>Chronic Disease</mesh_term>
      <mesh_term>Depressive Disorder</mesh_term>
      <mesh_term>Anxiety Disorders</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ketamine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Undecided</ipd_description>
    </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/NCT06038409
  org study id: RIVERFoundation 001
  nct id: NCT06038409
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  A study aimed to assess the efficacy of the various approaches to prescribing Ketamine
        currently in use off-label. The focus will be to include ketamine within the study plan of
        those with chronic conditions who are receiving ketamine.
  Ketamine can be administered in multiple ways (IV, IM, SubQ, and Sublingual, among others),
        and there have been few if any, studies that have compared the impact of Ketamine at home
        without any thearpy.
  
        The study will identify other treatment modalities used in concurrence with Ketamine.
        Psychotherapy, music therapy, and acutherapy are some of the most popular. How do these
        adjunct therapies affect the outcomes of Ketamine treatments?
  
        Secondarily, the study will focus on these significant issues to observe the impact of
        Ketamine treatments and suicidal ideation. Suicidal ideation is multifaceted and is one
        reason for prescribing off-label Ketamine. Chronic issues such as depression, pain, and
        anxiety have been identified as underlying causes and may be improvable with Ketamine.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Ketamine route of use acceptability.
  time frame: through study completion, an average of 1 year
  description: Compare and Contrast the different methods and uses of ketamine for acceptability for the route of use. (ie oral sublingual or nasal spray)
  measure: Mental Health PHQ9
  time frame: through study completion, an average of 1 year
  description: The use of psychological scales to measure participants' mental health with the use of ketamine. Three scales will be charted to examine the mental health of the participant.
  The Patient Health Questionnaire-9 (PHQ9), Patient Health Questionnaire 9 has a possible range of 0-27. Zero being no depression and 27 being severe depression.
  Participants will be given a baseline survey and will be given a survey to complete every time they request a ketamine renewal while participating in the study. A multiline graph will show the results of the amount of ketamine and the PHQ9 will be produced.
  measure: Mental Health GAD7
  time frame: through study completion, an average of 1 year
  description: Participants will be screened using the Generalized Anxiety Disorder-7 (GAD7) with a total score for the seven items ranging from 0 to 21. Scores 5, 10, and 15 represent cut points for mild, moderate, and severe anxiety, respectively.
  Participants will be given a baseline survey and will be given a survey to complete every time they request a ketamine renewal while participating in the study. A multiline graph will show the results of the amount of ketamine and the GAD7 will be produced.
  measure: Mental Health PCL5
  time frame: through study completion, an average of 1 year
  description: Participants will be screened using the Posttraumatic Stress Disorder Checklist (PCL-5) PCL-5. On a 4-point scale, scores can be tabulated for individual items to give information about the severity of the four DSM-5 symptom clusters. If a score of 2 (moderate) is considered to be a positive endorsement of a given criterion, the PCL-5 can be used in combination with a clinical interview to make a provisional DSM-5 diagnosis. Testing the PCL-5 with veterans has determined a score of 31 to 33 to be a valid cutoff for a positive screen. The scores range from 0-80, 0 being no symptoms to extreme issues with post-traumatic stress disorder.
  Participants will be given a baseline survey and will be given a survey to complete every time they request a ketamine renewal while participating in the study. A multiline graph will show the results of the amount of ketamine and the PCL5 will be produced.
  arm group label: Chronic Pain
  description: The use of ketamine in chronic pain
  arm group label: Depressive Disorders
  description: The use of ketamine in depressive disorders
  arm group label: Anxiety Disorders
  description: The use of ketamine in anxiety disorders
  arm group label: Chronic Condtions
  description: The use of ketamine in chronic conditions
  intervention type: Drug
  intervention name: Ketamine
  description: The efficacy of the various approaches to prescribing Ketamine currently in use off-label. The focus will be to include ketamine within the treatment plan of those with chronic conditions
  arm group label: Anxiety Disorders
  arm group label: Chronic Condtions
  arm group label: Chronic Pain
  arm group label: Depressive Disorders
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Edward Lesofski, MS
  role: Study Director
  affiliation: RIVER Foundation
  last name: Ed Lesofski
  phone: 406-465-9504
  email: ed@riverofchange.org
  last name: James Taggart, MD
  phone: 415-713-6654
  email: jrtaggartmd@aol.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  url: http://research.riverofchange.org
  description: RIVER's research web site
  responsible party type: Sponsor
  mesh term: Chronic Pain
  mesh term: Chronic Disease
  mesh term: Depressive Disorder
  mesh term: Anxiety Disorders
  mesh term: Ketamine
  sharing ipd: Undecided
  ipd description: Undecided