<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/NCT04470050</url>
  </required_header>
  <id_info>
    <org_study_id>BXCL501-201</org_study_id>
    <nct_id>NCT04470050</nct_id>
  </id_info>
  <brief_title>Dexmedetomidine in the Treatment of Symptoms Of Acute Opioid Withdrawal</brief_title>
  <acronym>RELEASE</acronym>
  <official_title>A Phase 1b/2 Randomized, Double-Blind, Placebo-Controlled, Ascending- Dose Study of BXCL501 to Treat Symptoms of Acute Opioid Withdrawal in Patients With Opioid Use Disorder Who Are Physically Dependent on Opioids</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioXcel Therapeutics Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Cognitive Research Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>BioXcel Therapeutics Inc</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a dose-ranging study to support the safety and efficacy evaluation of BXCL501 to&#xD;
      treat the symptoms of acute opioid withdrawal. The BXCL501-201 study is designed to&#xD;
      characterize the efficacy, safety, tolerability, and pharmacokinetics of escalating doses of&#xD;
      BXCL501 (sublingual film formulation of DEX, HCl) versus placebo following discontinuation of&#xD;
      morphine maintenance in patients with opioid use disorder who are physically dependent on&#xD;
      opioids.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will enroll approximately 125 patients randomized 4:1 to dose regimens of twice a&#xD;
      day dosing of 30µg, 60µg, 90µg, 120µg, and 180µg of BXCL501 or placebo. Male and female&#xD;
      adults with opioid use disorder who are physically dependent on opioids will be enrolled to&#xD;
      treat symptoms of acute opioid withdrawal following discontinuation of morphine maintenance.&#xD;
      Patients will be domiciled in an inpatient unit to remain under medical supervision after&#xD;
      deemed eligible for the study. Efficacy and safety assessments will be conducted periodically&#xD;
      before and after dosing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 12, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Phase 1b/2, randomized, double-blind, placebo-controlled, ascending dose</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double-blind, placebo-controlled</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Adverse Events</measure>
    <time_frame>14 days</time_frame>
    <description>Incidence of Adverse Events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reasons for withdrawal related to safety</measure>
    <time_frame>14 days</time_frame>
    <description>Listings of subjects who withdraw from the study due to an AE, serious AEs and/or death or lack of treatment effect</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of abnormal vital signs</measure>
    <time_frame>14 days</time_frame>
    <description>Incidence of abnormal vital signs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peak SOWS (Subjective Opiate Withdrawal Scale) scores</measure>
    <time_frame>14 days</time_frame>
    <description>After the morphine maintenance phase, treatment differences between BXCL501 and placebo on peak SOWS (Subjective Opiate Withdrawal Scale, range 0-64 with higher score meaning worse outcome) scores will be analyzed using linear regression or Mixed Model Repeated Measures [MMRM].</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">125</enrollment>
  <condition>Opioid Withdrawal</condition>
  <arm_group>
    <arm_group_label>Cohort 1- 30 Micrograms</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sublingual film containing 30 Micrograms Dexmedetomidine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2- 60 Micrograms</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sublingual film containing 60 Micrograms Dexmedetomidine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3- 90 Micrograms</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sublingual film containing 90 Micrograms Dexmedetomidine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4- 120 Micrograms</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sublingual film containing 120 Micrograms Dexmedetomidine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 5- 180 Micrograms</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sublingual film containing 180 Micrograms Dexmedetomidine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 6- Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sublingual placebo film</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sublingual film containing Dexmedetomidine (BXCL501)</intervention_name>
    <description>Sublingual film containing Dexmedetomidine (BXCL501)</description>
    <arm_group_label>Cohort 1- 30 Micrograms</arm_group_label>
    <arm_group_label>Cohort 2- 60 Micrograms</arm_group_label>
    <arm_group_label>Cohort 3- 90 Micrograms</arm_group_label>
    <arm_group_label>Cohort 4- 120 Micrograms</arm_group_label>
    <arm_group_label>Cohort 5- 180 Micrograms</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo film for BXCL501</intervention_name>
    <description>Placebo film for BXCL501</description>
    <arm_group_label>Cohort 6- Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        A patient will be eligible for inclusion in the study if he or she meets the following&#xD;
        criteria:&#xD;
&#xD;
          1. Male and female patients between the ages of 18-64, inclusive.&#xD;
&#xD;
          2. Patients who have met DSM-5 criteria for moderate to severe opioid use disorder&#xD;
             confirmed by the Mini-International Neuropsychiatric Interview (MINI) with&#xD;
             physiological dependence as evidenced by a Clinical Opiate Withdrawal (COWS) score of&#xD;
             &gt;5 or a positive naloxone challenge upon inpatient admission.&#xD;
&#xD;
          3. Patients who read, understand, and provide written informed consent.&#xD;
&#xD;
          4. Participants who agree to use a medically acceptable and effective birth control&#xD;
             method.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        A patient will be excluded from the study if he or she meets the following criteria:&#xD;
&#xD;
          1. Female patients who have a positive urine pregnancy test at screening or when tested&#xD;
             or currently breast feeding.&#xD;
&#xD;
          2. Clinically significant history of cardiac disease.&#xD;
&#xD;
          3. History or presence of a significant medical disease or disorder.&#xD;
&#xD;
          4. Hepatic dysfunction at the screening visit.&#xD;
&#xD;
          5. Acute active Hepatitis B or C.&#xD;
&#xD;
          6. Patients with ECG abnormalities considered clinically significant by the investigator.&#xD;
&#xD;
          7. Any psychiatric disorder that would compromise ability to complete study requirements.&#xD;
&#xD;
          8. Currently meets DSM-5 criteria for substance abuse disorder, moderate or severe, for&#xD;
             any substance other than opioids, caffeine, or nicotine.&#xD;
&#xD;
          9. History of suicidal behavior within the last 1 year prior to screening.&#xD;
&#xD;
         10. Patients who have received an investigational drug within 30 days prior to screening.&#xD;
&#xD;
         11. Use of any excluded medication at screening or anticipated/required use during the&#xD;
             study period.&#xD;
&#xD;
         12. Patients with a history of intolerance to morphine.&#xD;
&#xD;
         13. Any finding that, in the view of the investigator, would compromise the patient's&#xD;
             ability to fulfill the protocol visit schedule or visit requirements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Cedric Burg</last_name>
    <phone>475-238-6837</phone>
    <email>cburg@bioxceltherapeutics.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>BioXcel Clinical Research Site</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>BioXcel CTM</last_name>
      <phone>475-238-6837</phone>
      <email>info@bioxceltherapeutics.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>BioXcel Clinical Research Site</name>
      <address>
        <city>Marlton</city>
        <state>New Jersey</state>
        <zip>08053</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>BioXcel CTM</last_name>
      <phone>475-238-6837</phone>
      <email>info@bioxceltherapeutics.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>BioXcel Clinical Research Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>BioXcel CTM</last_name>
      <phone>475-238-6837</phone>
      <email>info@bioxceltherapeutics.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</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>Substance Withdrawal Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>August 11, 2023</submitted>
    <returned>September 5, 2023</returned>
  </pending_results>
  <!-- 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/NCT04470050
org study id: BXCL501-201
nct id: NCT04470050
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a dose-ranging study to support the safety and efficacy evaluation of BXCL501 to
      treat the symptoms of acute opioid withdrawal. The BXCL501-201 study is designed to
      characterize the efficacy, safety, tolerability, and pharmacokinetics of escalating doses of
      BXCL501 (sublingual film formulation of DEX, HCl) versus placebo following discontinuation of
      morphine maintenance in patients with opioid use disorder who are physically dependent on
      opioids.
The study will enroll approximately 125 patients randomized 4:1 to dose regimens of twice a
      day dosing of 30µg, 60µg, 90µg, 120µg, and 180µg of BXCL501 or placebo. Male and female
      adults with opioid use disorder who are physically dependent on opioids will be enrolled to
      treat symptoms of acute opioid withdrawal following discontinuation of morphine maintenance.
      Patients will be domiciled in an inpatient unit to remain under medical supervision after
      deemed eligible for the study. Efficacy and safety assessments will be conducted periodically
      before and after dosing.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Phase 1b/2, randomized, double-blind, placebo-controlled, ascending dose
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double-blind, placebo-controlled
measure: Incidence of Adverse Events
time frame: 14 days
description: Incidence of Adverse Events
measure: Reasons for withdrawal related to safety
time frame: 14 days
description: Listings of subjects who withdraw from the study due to an AE, serious AEs and/or death or lack of treatment effect
measure: Incidence of abnormal vital signs
time frame: 14 days
description: Incidence of abnormal vital signs
measure: Peak SOWS (Subjective Opiate Withdrawal Scale) scores
time frame: 14 days
description: After the morphine maintenance phase, treatment differences between BXCL501 and placebo on peak SOWS (Subjective Opiate Withdrawal Scale, range 0-64 with higher score meaning worse outcome) scores will be analyzed using linear regression or Mixed Model Repeated Measures [MMRM].
arm group label: Cohort 1- 30 Micrograms
arm group type: Experimental
description: Sublingual film containing 30 Micrograms Dexmedetomidine
arm group label: Cohort 2- 60 Micrograms
arm group type: Experimental
description: Sublingual film containing 60 Micrograms Dexmedetomidine
arm group label: Cohort 3- 90 Micrograms
arm group type: Experimental
description: Sublingual film containing 90 Micrograms Dexmedetomidine
arm group label: Cohort 4- 120 Micrograms
arm group type: Experimental
description: Sublingual film containing 120 Micrograms Dexmedetomidine
arm group label: Cohort 5- 180 Micrograms
arm group type: Experimental
description: Sublingual film containing 180 Micrograms Dexmedetomidine
arm group label: Cohort 6- Placebo
arm group type: Placebo Comparator
description: Sublingual placebo film
intervention type: Drug
intervention name: Sublingual film containing Dexmedetomidine (BXCL501)
description: Sublingual film containing Dexmedetomidine (BXCL501)
arm group label: Cohort 1- 30 Micrograms
arm group label: Cohort 2- 60 Micrograms
arm group label: Cohort 3- 90 Micrograms
arm group label: Cohort 4- 120 Micrograms
arm group label: Cohort 5- 180 Micrograms
intervention type: Drug
intervention name: Placebo film for BXCL501
description: Placebo film for BXCL501
arm group label: Cohort 6- Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Cedric Burg
phone: 475-238-6837
email: cburg@bioxceltherapeutics.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Substance Withdrawal Syndrome
mesh term: Dexmedetomidine
submitted: August 11, 2023
returned: September 5, 2023