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/NCT06001372</url>
    </required_header>
    <id_info>
      <org_study_id>HCI160227</org_study_id>
      <nct_id>NCT06001372</nct_id>
    </id_info>
    <brief_title>Ketamine-assisted Psychotherapy (KAP) for Patients With Existential Distress Associated With Non-operable GI Cancers</brief_title>
    <acronym>TREK</acronym>
    <official_title>TREK: Ketamine-assisted Psychotherapy (KAP) for Patients With Existential Distress Associated With Non-operable GI Cancers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Utah</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Utah</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this open-label clinical trial is to assess the feasibility of Ketamine-assisted&#xD;
        psychotherapy (KAP) studies for adults with non-operable GI cancers suffering with&#xD;
        existential distress. The main questions it aims to answer are:&#xD;
  &#xD;
          -  Is it feasible to conduct a KAP study with this population?&#xD;
  &#xD;
          -  What is the safety and tolerability of KAP in this population?&#xD;
  &#xD;
          -  How prevalent is existential distress in this population?&#xD;
  &#xD;
        Participants will undergo KAP administered as standard of care at the HMHI Park City&#xD;
        Ketamine-Assisted Psychotherapy Clinic and will complete health assessments over the course&#xD;
        of the study, as well as during the therapy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
    <phase>Early Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Single group, open label pilot study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The rate of study completion by enrolled participants. Study completion is defined as participating in at least 2 of the 3 Ketamine-Assisted Psychotherapy (KAP) sessions.</measure>
      <time_frame>One year</time_frame>
      <description>To assess the feasibility of completion of the study intervention by 12 participants.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment.</measure>
      <time_frame>One year</time_frame>
      <description>To assess the safety and tolerability of ketamine-assisted therapy in the study population.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The proportion of screened patients that meet criteria on the Existential Distress Scale (EDS: Single domain ≥ 3 or total score ≥ 6).</measure>
      <time_frame>One year</time_frame>
      <description>To determine the prevalence of existential distress in patients with non-operable GI cancers.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Gastrointestinal Cancer</condition>
    <condition>Depression</condition>
    <condition>Anxiety</condition>
    <arm_group>
      <arm_group_label>Arm 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Three 2.5-3 hour Ketamine Assisted Psychotherapy sessions, each 2-7 days apart</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ketamine</intervention_name>
      <description>Ketamine, 0.5-1.2mg/kg, administered intramuscularly&#xD;
  Doses can range 0.5-1.2 mg/kg. Starting dose for all participants will be 0.5mg/kg.&#xD;
  Dose can be titrated up to maximum of 1.2 mg/kg or titrated down to 0.5 mg/kg based on response and clinical judgement.&#xD;
  Dose will be administered by injecting into large muscle mass (eg, deltoid, gluteal muscle, thigh)</description>
      <arm_group_label>Arm 1</arm_group_label>
      <other_name>Ketamine Assisted Psychotherapy</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participant aged ≥ 18 years.&#xD;
  &#xD;
            -  Participant with non-operable GI cancers&#xD;
  &#xD;
            -  Screen positivity for existential distress on the EDS, defined as scoring ≥ 3 on any&#xD;
               of the 10 component domains, or a total score ≥ 6&#xD;
  &#xD;
            -  ECOG Performance Status ≤ 2.&#xD;
  &#xD;
            -  Adequate hepatic function as defined as:&#xD;
  &#xD;
                 -  Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN) unless elevated&#xD;
                    bilirubin is related to Gilbert's Syndrome&#xD;
  &#xD;
                 -  AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN&#xD;
  &#xD;
                      -  Subjects with liver metastases will be allowed to enroll with AST and ALT&#xD;
                         levels ≤ 5 x ULN.&#xD;
  &#xD;
            -  For participants of childbearing potential: Negative pregnancy test or evidence of&#xD;
               post-menopausal status. The post-menopausal status will be defined as having been&#xD;
               amenorrheic for 12 months without an alternative medical cause. The following&#xD;
               age-specific requirements apply:&#xD;
  &#xD;
                 -  Participants &lt; 50 years of age:&#xD;
  &#xD;
                      -  Amenorrheic for ≥ 12 months following cessation of exogenous hormonal&#xD;
                         treatments; and&#xD;
  &#xD;
                      -  Luteinizing hormone and follicle-stimulating hormone levels in the&#xD;
                         post-menopausal range for the institution; or&#xD;
  &#xD;
                      -  Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).&#xD;
  &#xD;
                 -  Participants ≥ 50 years of age:&#xD;
  &#xD;
                      -  Amenorrheic for 12 months or more following cessation of all exogenous&#xD;
                         hormonal treatments; or&#xD;
  &#xD;
                      -  Had radiation-induced menopause with last menses &gt;1 year ago; or&#xD;
  &#xD;
                      -  Had chemotherapy-induced menopause with last menses &gt;1 year ago; or&#xD;
  &#xD;
                      -  Underwent surgical sterilization (bilateral oophorectomy, bilateral&#xD;
                         salpingectomy, or hysterectomy).&#xD;
  &#xD;
            -  Participants of childbearing potential and subjects with a sexual partner of&#xD;
               childbearing potential must agree to use a highly effective method of contraception.&#xD;
  &#xD;
            -  Participants with a sexual partner of childbearing potential must agree to use a&#xD;
               condom during intercourse for 24 hours post- ketamine dose.&#xD;
  &#xD;
            -  Agree to refrain from using any psychoactive drugs, including alcoholic beverages,&#xD;
               ondansetron, cannabis, and non-routine PRN medications within 24 hours of each&#xD;
               ketamine administration. Exceptions include daily use of caffeine, nicotine, and&#xD;
               opioid pain medication&#xD;
  &#xD;
            -  Able to provide informed consent and willing to sign an approved consent form that&#xD;
               conforms to federal and institutional guidelines.&#xD;
  &#xD;
            -  Agree that for one week preceding the ketamine session, he/she will refrain from&#xD;
               taking any nonprescription medication, nutritional supplement, or herbal supplement&#xD;
               except when approved by the research team. Exceptions will be evaluated by the&#xD;
               research team and will include acetaminophen, non-steroidal anti-inflammatory drugs,&#xD;
               and common doses of vitamins and minerals.&#xD;
  &#xD;
            -  Agree not to use nicotine for at least 2 hours before the ketamine administration or&#xD;
               for the duration of the ketamine session.&#xD;
  &#xD;
            -  Agree to consume approximately the same amount of caffeine-containing beverage (e.g.,&#xD;
               coffee, tea) that he/she consumes on a usual morning, before arriving at the research&#xD;
               unit on the morning of the ketamine session. If the participant does not routinely&#xD;
               consume caffeinated beverages, he or she must agree not to do so on the day of&#xD;
               ketamine administration.&#xD;
  &#xD;
            -  Participants requiring opioid use for pain are on a stable pain management regimen.&#xD;
               Note: Long-acting opioid medications (e.g., oxycodone sustained-release, morphine&#xD;
               sustained release) will be allowed if the last dose occurred at least 6 hours before&#xD;
               ketamine administration; such medication will not be taken again until at least 6&#xD;
               hours after ketamine administration.&#xD;
  &#xD;
            -  Fluent in English.&#xD;
  &#xD;
            -  Reading literacy and comprehension sufficient for understanding the consent form and&#xD;
               study questionnaires, as evaluated by study staff obtaining consent.&#xD;
  &#xD;
            -  Have a support person who is be able to escort the participant home from the ketamine&#xD;
               dosing sessions. Note: The use of ride services will not be permitted (e.g., Uber,&#xD;
               Lift, taxi, etc.)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Received ketamine treatments for a psychiatric condition within 6 months of&#xD;
               enrollment.&#xD;
  &#xD;
            -  Personal history or first- or second-degree relatives with schizophrenia, bipolar&#xD;
               affective disorder, delusional disorder, schizoaffective disorder, psychosis, or other&#xD;
               psychotic spectrum illness.&#xD;
  &#xD;
            -  Currently meeting DSM-5 criteria for Dissociative Disorder, or other psychiatric&#xD;
               conditions judged to be incompatible with the establishment of rapport or safe&#xD;
               exposure to ketamine.&#xD;
  &#xD;
            -  Currently meeting DSM-5 criteria for Cluster B Personality Disorder.&#xD;
  &#xD;
            -  Severe depression requiring immediate standard-of-care treatment (e.g.,&#xD;
               hospitalization).&#xD;
  &#xD;
            -  Suicidal ideation over the past month as assessed as a yes to question 3, 4, or 5 on&#xD;
               the Columbia-Suicide Severity Rating Scale, Suicidal Ideation section&#xD;
  &#xD;
            -  Cancer with known CNS involvement, previously treated brain metastasis, or other major&#xD;
               CNS disease.&#xD;
  &#xD;
            -  Current or history within the last two years of meeting DSM-V criteria of substance&#xD;
               use disorder (excluding caffeine and nicotine). Current substance use disorders may be&#xD;
               identified through the drug urine screening test.&#xD;
  &#xD;
            -  Current evidence of uncontrolled, significant intercurrent illness including, but not&#xD;
               limited to, the following conditions:&#xD;
  &#xD;
                 -  Cardiovascular disorders:&#xD;
  &#xD;
                      -  Any grade congestive heart failure, unstable angina pectoris, serious&#xD;
                         cardiac arrhythmias including tachycardia, or clinically significant&#xD;
                         screening ECG abnormalities.&#xD;
  &#xD;
                      -  Cardiac hypertrophy or artificial heart valve.&#xD;
  &#xD;
                      -  Stroke (including transient ischemic attack [TIA]), myocardial infarction&#xD;
                         (MI), or other ischemic events, or thromboembolic event (eg, deep venous&#xD;
                         thrombosis, pulmonary embolism), and/or significant coronary artery disease&#xD;
                         within 3 months before the first dose.&#xD;
  &#xD;
                      -  QTc prolongation defined as a QTcF &gt; 450 ms.&#xD;
  &#xD;
                      -  Known congenital long QT.&#xD;
  &#xD;
                      -  Uncontrolled hypertension defined as ≥ 140/90 as assessed from the mean of&#xD;
                         three consecutive blood pressure measurements taken over 10 minutes.&#xD;
  &#xD;
                 -  Seizure disorder&#xD;
  &#xD;
                 -  Moderate to severe dementia&#xD;
  &#xD;
                 -  History of significant traumatic brain injury&#xD;
  &#xD;
                 -  Requires the use of supplemental oxygen.&#xD;
  &#xD;
                 -  Renal insufficiency as defined as creatinine clearance &lt; 40 mL/min calculated by&#xD;
                    Cockcroft-Gault formula&#xD;
  &#xD;
                 -  Any other condition that would, in the Investigator's judgment, contraindicate&#xD;
                    the participant's participation in the clinical study due to safety concerns or&#xD;
                    compliance with clinical study procedures (e.g., infection/inflammation,&#xD;
                    intestinal obstruction, unable to swallow medication, [participants may not&#xD;
                    receive the drug through a feeding tube], social/ psychological issues, etc.)&#xD;
  &#xD;
            -  Known HIV infection with a detectable viral load within 6 months of the anticipated&#xD;
               start of treatment. Note: Participants on effective antiretroviral therapy with an&#xD;
               undetectable viral load within 6 months of the anticipated start of treatment are&#xD;
               eligible for this trial.&#xD;
  &#xD;
            -  Active infection including tuberculosis (clinical evaluation that includes clinical&#xD;
               history, physical examination, radiographic findings, and TB testing in line with&#xD;
               local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), or&#xD;
               hepatitis C. Note: Participants with a past or resolved HBV infection (defined as the&#xD;
               presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible.&#xD;
               Participants positive for hepatitis C (HCV) antibody are eligible only if polymerase&#xD;
               chain reaction is negative for HCV RNA.&#xD;
  &#xD;
            -  Medical, psychiatric, cognitive, or other conditions that may compromise the&#xD;
               participant's ability to understand the participant information, give informed&#xD;
               consent, comply with the study protocol or complete the study.&#xD;
  &#xD;
            -  Known prior severe hypersensitivity to ketamine or any component in its formulations&#xD;
               (NCI CTCAE v5.0 Grade ≥ 3).&#xD;
  &#xD;
            -  Participants taking prohibited medications as described in Section 6.5.1. A washout&#xD;
               period of prohibited medications for a period of at least five half-lives or as&#xD;
               clinically indicated should occur before the start of treatment.&#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>Benjamin Lewis, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Huntsman Cancer Institute/ University of Utah</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Susan Sharry</last_name>
      <phone>801-585-3453</phone>
      <email>susan.sharry@hci.utah.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Huntsman Cancer Institute</name>
        <address>
          <city>Salt Lake City</city>
          <state>Utah</state>
          <zip>84108</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Benjamin Lewis, MD</last_name>
        <phone>435-655-5128</phone>
        <email>ben.lewis@hsc.utah.edu</email>
      </contact>
      <investigator>
        <last_name>Benjamin Lewis, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Ketamine Assisted Therapy</keyword>
    <keyword>Existential Distress</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gastrointestinal Neoplasms</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>No</sharing_ipd>
    </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/NCT06001372
  org study id: HCI160227
  nct id: NCT06001372
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The goal of this open-label clinical trial is to assess the feasibility of Ketamine-assisted
        psychotherapy (KAP) studies for adults with non-operable GI cancers suffering with
        existential distress. The main questions it aims to answer are:
  
          -  Is it feasible to conduct a KAP study with this population?
  
          -  What is the safety and tolerability of KAP in this population?
  
          -  How prevalent is existential distress in this population?
  
        Participants will undergo KAP administered as standard of care at the HMHI Park City
        Ketamine-Assisted Psychotherapy Clinic and will complete health assessments over the course
        of the study, as well as during the therapy.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Single group, open label pilot study
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The rate of study completion by enrolled participants. Study completion is defined as participating in at least 2 of the 3 Ketamine-Assisted Psychotherapy (KAP) sessions.
  time frame: One year
  description: To assess the feasibility of completion of the study intervention by 12 participants.
  measure: The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment.
  time frame: One year
  description: To assess the safety and tolerability of ketamine-assisted therapy in the study population.
  measure: The proportion of screened patients that meet criteria on the Existential Distress Scale (EDS: Single domain ≥ 3 or total score ≥ 6).
  time frame: One year
  description: To determine the prevalence of existential distress in patients with non-operable GI cancers.
  arm group label: Arm 1
  arm group type: Experimental
  description: Three 2.5-3 hour Ketamine Assisted Psychotherapy sessions, each 2-7 days apart
  intervention type: Drug
  intervention name: Ketamine
  description: Ketamine, 0.5-1.2mg/kg, administered intramuscularly
  Doses can range 0.5-1.2 mg/kg. Starting dose for all participants will be 0.5mg/kg.
  Dose can be titrated up to maximum of 1.2 mg/kg or titrated down to 0.5 mg/kg based on response and clinical judgement.
  Dose will be administered by injecting into large muscle mass (eg, deltoid, gluteal muscle, thigh)
  arm group label: Arm 1
  other name: Ketamine Assisted Psychotherapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Benjamin Lewis, MD
  role: Principal Investigator
  affiliation: Huntsman Cancer Institute/ University of Utah
  last name: Susan Sharry
  phone: 801-585-3453
  email: susan.sharry@hci.utah.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Gastrointestinal Neoplasms
  mesh term: Ketamine
  sharing ipd: No